<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03032250</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00038084</org_study_id>
    <secondary_id>NCI-2016-02045</secondary_id>
    <secondary_id>CCCWFU 99616</secondary_id>
    <secondary_id>P30CA012197</secondary_id>
    <secondary_id>R03CA208560</secondary_id>
    <nct_id>NCT03032250</nct_id>
  </id_info>
  <brief_title>Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer CaregiversHead and Neck Cancer</brief_title>
  <official_title>Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer Caregivers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot clinical trial studies how well Prepare to Care kit works in improving caregiver&#xD;
      support in patients with stage I-IV head and neck cancer that is new or has come back.&#xD;
      Prepare to Care kit may increase knowledge about head and neck cancer and enhance&#xD;
      stress-management skills.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To assess feasibility (accrual, participation, and retention) and acceptability of a&#xD;
      supported self-management intervention for psycho-education and stress management skills&#xD;
      building designed for informal caregivers (intervention group n=20; waitlist control group,&#xD;
      n=20) of head and neck cancer (HNC) patients undergoing radiotherapy (RT).&#xD;
&#xD;
      II. To obtain preliminary data on caregiver intermediate (self-efficacy for [a] coping with&#xD;
      cancer and [b] abbreviated progressive muscle relaxation) and outcome variables (burden,&#xD;
      psychological distress, quality of life) in intervention caregivers and waitlist control&#xD;
      caregivers at the start of radiation (T1), end of radiation (T2), and 6-weeks post-radiation&#xD;
      (T3).&#xD;
&#xD;
      III. To compare intermediate (self-efficacy for (a) coping with cancer and (b) abbreviated&#xD;
      progressive muscle relaxation) and outcome variables (burden, psychological distress, quality&#xD;
      of life) between intervention caregivers and waitlist control caregivers at T1, T2, and T3.&#xD;
&#xD;
      IV. To obtain preliminary data on caregiver cortisol response (cortisol slope, cortisol&#xD;
      awakening&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 groups.&#xD;
&#xD;
      GROUP I: Caregivers watch introduction video on a digital video disc (DVD) over 10 minutes at&#xD;
      baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at&#xD;
      least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session&#xD;
      over 10-30 minutes weekly.&#xD;
&#xD;
      GROUP II: Caregivers receive educational intervention as in Group I but do not attend&#xD;
      interventionist sessions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2017</start_date>
  <completion_date type="Actual">April 10, 2020</completion_date>
  <primary_completion_date type="Actual">April 10, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions</measure>
    <time_frame>Six weeks post radiation therapy</time_frame>
    <description>10-item quantitative survey will be developed for study to assess how much caregivers liked different aspects of the intervention. Acceptability will be summarized quantitatively and qualitatively. These acceptability questions were asked only of caregivers in the intervention group - Group 1 Supportive Care (Prepare to Care Kit). All data is based on participants answering the acceptability questions as &quot;Quite a Bit/Very Much Helpful&quot; for the intervention materials. Not all participants answered this part of the outcome measure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Accrual Assessed by Number of Caregivers Who Agreed to Participate Divided by the Number of Months of Recruitment</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>38 patient/caregiver dyads agreed to participate, 22 months of recruitment, for accrual rate of 1.7 (caregiver) participants per month</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA)</measure>
    <time_frame>Baseline and following radiotherapy, assessed up to 1 year</time_frame>
    <description>21-item instrument assessing positive and negative aspects of caregiving (esteem, lack of family support, finances, schedule, and health). The CRA has been tested in cancer caregivers; demonstrated validity and reliability. Minimum and maximum scoring scale: BASELINE: Scores for esteem 15-31; lack of family support 5-15, impact of finances 3-12, impact of schedule 12-23, impact of health 11-16). AFTER RADIOTHERAPY: Scores for esteem 20-31; lack of family support 9-17, impact of finances 7-11, impact of schedule 14-22, impact of health 12-17). The higher the score the more the item being assessed impacted the participant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Psychological Distress - Center for Epidemiological Studies Depression (CESD)</measure>
    <time_frame>Before and after radiotherapy, assessed up to 1 year</time_frame>
    <description>The score is the sum of the 20 questions. Possible scoring range is 0-60. A score of 16 points or more is considered depressed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc)</measure>
    <time_frame>Before and after radiotherapy, assessed up to 1 year</time_frame>
    <description>35-item instrument assessing dimensions of caregiver quality of life (burden, disruptiveness, positive adaptation, financial concerns). The Cqol-Canc has demonstrated validity and reliability. Minimum and maximum score at baseline is a range of 9-78 and after radiotherapy a range of 2-73. The higher the score the greater the level of change in the quality of life for participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of Intervention Modules Utilized Assessed by Caregiver Logs</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Data on intervention resources used and time spent using them based on caregivers in intervention group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants in Agreement to Perform Interventions</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Participation assessed by number of eligible participants who agreed to participate and complete study interventions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retention Assessed by Number of Participants Who Completed the End of Radiotherapy Visit Divided by the Number Who Agreed to Participate</measure>
    <time_frame>Up to 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-efficacy in Abbreviated Progressive Muscle Relaxation (APMR)</measure>
    <time_frame>At baseline and up to the end of radiotherapy, assessed up to 1 year</time_frame>
    <description>A 3-item instrument developed for study to evaluate self-efficacy in APMR. Minimum to maximum scores range from 3-27. Higher scores demonstrate higher self efficacy in participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-efficacy in Coping With Cancer Caregiver Inventory</measure>
    <time_frame>At baseline and up to the end of radiotherapy, assessed up to 1 year</time_frame>
    <description>21-item instrument assessing caregivers' perceived self-efficacy for coping with cancer (managing medical information, caring for care recipient, caring for oneself, managing difficult interactions/emotions); demonstrated validity and reliability. Minimum and maximum scores range from 10-63. Higher scores indicate higher self-efficacy in coping with cancer from the participants.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Salivary Cortisol Collection</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>For eligible caregivers only - collected three times a day (at awakening, 30 minutes post-awakening, and bedtime) for two consecutive days following T1 (start of radiation), T2 (end of radiation), and T3 (6 weeks post radiation). To obtain preliminary data on caregiver cortisol response (cortisol slope, cortisol awakening response, area under the curve, and intra-individual cortisol variability). Investigators will use a mixed model to evaluate differences between the groups in these parameters at times T1 and T2 and T3</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Caregiver</condition>
  <condition>Malignant Head and Neck Neoplasm</condition>
  <condition>Paranasal Sinus Squamous Cell Carcinoma</condition>
  <condition>Salivary Gland Squamous Cell Carcinoma</condition>
  <condition>Stage I Hypopharyngeal Squamous Cell Carcinoma</condition>
  <condition>Stage I Laryngeal Squamous Cell Carcinoma</condition>
  <condition>Stage I Lip and Oral Cavity Squamous Cell Carcinoma</condition>
  <condition>Stage I Oropharyngeal Squamous Cell Carcinoma</condition>
  <condition>Stage II Hypopharyngeal Squamous Cell Carcinoma</condition>
  <condition>Stage II Laryngeal Squamous Cell Carcinoma</condition>
  <condition>Stage II Lip and Oral Cavity Squamous Cell Carcinoma</condition>
  <condition>Stage II Oropharyngeal Squamous Cell Carcinoma</condition>
  <condition>Stage III Hypopharyngeal Squamous Cell Carcinoma</condition>
  <condition>Stage III Laryngeal Squamous Cell Carcinoma</condition>
  <condition>Stage III Lip and Oral Cavity Squamous Cell Carcinoma</condition>
  <condition>Stage III Oropharyngeal Squamous Cell Carcinoma</condition>
  <condition>Stage IV Hypopharyngeal Squamous Cell Carcinoma</condition>
  <condition>Stage IV Laryngeal Squamous Cell Carcinoma</condition>
  <condition>Stage IV Lip and Oral Cavity Squamous Cell Carcinoma</condition>
  <condition>Stage IV Oropharyngeal Squamous Cell Carcinoma</condition>
  <condition>Stage IVA Hypopharyngeal Squamous Cell Carcinoma</condition>
  <condition>Stage IVA Laryngeal Squamous Cell Carcinoma</condition>
  <condition>Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma</condition>
  <condition>Stage IVA Oropharyngeal Squamous Cell Carcinoma</condition>
  <condition>Stage IVB Hypopharyngeal Squamous Cell Carcinoma</condition>
  <condition>Stage IVB Laryngeal Squamous Cell Carcinoma</condition>
  <condition>Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma</condition>
  <condition>Stage IVB Oropharyngeal Squamous Cell Carcinoma</condition>
  <condition>Stage IVC Hypopharyngeal Squamous Cell Carcinoma</condition>
  <condition>Stage IVC Laryngeal Squamous Cell Carcinoma</condition>
  <condition>Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma</condition>
  <condition>Stage IVC Oropharyngeal Squamous Cell Carcinoma</condition>
  <condition>Recurrent Head and Neck Squamous Cell Carcinoma</condition>
  <condition>Recurrent Hypopharyngeal Squamous Cell Carcinoma</condition>
  <condition>Recurrent Laryngeal Squamous Cell Carcinoma</condition>
  <condition>Recurrent Lip and Oral Cavity Squamous Cell Carcinoma</condition>
  <condition>Recurrent Oropharyngeal SCC</condition>
  <condition>Recurrent Paranasal Sinus Squamous Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>Group I Supportive Care (Prepare to Care kit)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II Control Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Communication Intervention</intervention_name>
    <description>Attend interventionist sessions</description>
    <arm_group_label>Group I Supportive Care (Prepare to Care kit)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Watch video</intervention_name>
    <description>Watch video on a DVD</description>
    <arm_group_label>Group I Supportive Care (Prepare to Care kit)</arm_group_label>
    <arm_group_label>Group II Control Group</arm_group_label>
    <other_name>Education for Intervention</other_name>
    <other_name>Intervention by Education</other_name>
    <other_name>Intervention through Education</other_name>
    <other_name>Intervention, Educational</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Module completion of the Prepare to Care kit</intervention_name>
    <description>Complete modules of the Prepare to Care kit</description>
    <arm_group_label>Group I Supportive Care (Prepare to Care kit)</arm_group_label>
    <arm_group_label>Group II Control Group</arm_group_label>
    <other_name>Education for Intervention</other_name>
    <other_name>Intervention by Education</other_name>
    <other_name>Intervention through Education</other_name>
    <other_name>Intervention, Educational</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Group I Supportive Care (Prepare to Care kit)</arm_group_label>
    <arm_group_label>Group II Control Group</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Group I Supportive Care (Prepare to Care kit)</arm_group_label>
    <arm_group_label>Group II Control Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Salivary cortisol collection</intervention_name>
    <description>Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.</description>
    <arm_group_label>Group I Supportive Care (Prepare to Care kit)</arm_group_label>
    <arm_group_label>Group II Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        CAREGIVERS:&#xD;
&#xD;
          -  Providing the majority of the informal (unpaid) care during radiation therapy for a&#xD;
             patient meeting inclusion criteria and participating in study&#xD;
&#xD;
        CARE-RECIPIENTS:&#xD;
&#xD;
          -  Has a new or recurrent American Joint Committee on Cancer (AJCC) stage I-IV squamous&#xD;
             cell carcinoma of the upper aerodigestive tract (including lip/oral cavity,&#xD;
             nasopharynx, salivary gland, oropharynx, hypopharynx, paranasal sinus, and larynx&#xD;
             cancers)&#xD;
&#xD;
          -  Has planned external beam radiotherapy (+/- chemotherapy) for 6-7 weeks&#xD;
&#xD;
          -  Has an informal (unpaid) caregiver during radiation therapy who is participating in&#xD;
             study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  CAREGIVERS: Has a current cancer diagnosis&#xD;
&#xD;
          -  CAREGIVERS: Cannot read/communicate in English&#xD;
&#xD;
          -  CAREGIVERS: Have an endocrine disorder (e.g., diabetes and thyroid disorders), or is&#xD;
             currently taking a steroid based medication will not be eligible to participate in the&#xD;
             saliva portion of the study&#xD;
&#xD;
          -  CARE-RECIPIENTS: Cannot read/communicate in English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chandylen Nightingale</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Comprehensive Cancer Center of Wake Forest University</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <results_first_submitted>April 23, 2021</results_first_submitted>
  <results_first_submitted_qc>June 9, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 1, 2021</results_first_posted>
  <last_update_submitted>December 14, 2022</last_update_submitted>
  <last_update_submitted_qc>December 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Head and Neck Neoplasms</mesh_term>
    <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydrocortisone</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 4, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT03032250/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form: Caregiver Informed Consent</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 19, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT03032250/ICF_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form: Patient Informed Consent</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 19, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT03032250/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Group I Supportive Care (Prepare to Care Kit)</title>
          <description>Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.&#xD;
Communication Intervention: Attend interventionist sessions&#xD;
Watch video: Watch video on a DVD&#xD;
Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Survey Administration: Ancillary studies&#xD;
Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.</description>
        </group>
        <group group_id="P2">
          <title>Group II Control Group</title>
          <description>Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study.&#xD;
Watch video: Watch video on a DVD&#xD;
Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Survey Administration: Ancillary studies&#xD;
Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group I Supportive Care (Prepare to Care Kit)</title>
          <description>Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.&#xD;
Communication Intervention: Attend interventionist sessions&#xD;
Watch video: Watch video on a DVD&#xD;
Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Survey Administration: Ancillary studies&#xD;
Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.</description>
        </group>
        <group group_id="B2">
          <title>Group II Control Group</title>
          <description>Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study.&quot;&#xD;
Watch video: Watch video on a DVD&#xD;
Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Survey Administration: Ancillary studies&#xD;
Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="17"/>
            <count group_id="B2" value="18"/>
            <count group_id="B3" value="35"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.3" spread="15.5"/>
                    <measurement group_id="B2" value="57.4" spread="11.8"/>
                    <measurement group_id="B3" value="56.4" spread="13.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions</title>
        <description>10-item quantitative survey will be developed for study to assess how much caregivers liked different aspects of the intervention. Acceptability will be summarized quantitatively and qualitatively. These acceptability questions were asked only of caregivers in the intervention group - Group 1 Supportive Care (Prepare to Care Kit). All data is based on participants answering the acceptability questions as &quot;Quite a Bit/Very Much Helpful&quot; for the intervention materials. Not all participants answered this part of the outcome measure.</description>
        <time_frame>Six weeks post radiation therapy</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group I Supportive Care (Prepare to Care Kit)</title>
            <description>Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.&#xD;
Communication Intervention: Attend interventionist sessions&#xD;
Watch video: Watch video on a DVD&#xD;
Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Survey Administration: Ancillary studies&#xD;
Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions</title>
          <description>10-item quantitative survey will be developed for study to assess how much caregivers liked different aspects of the intervention. Acceptability will be summarized quantitatively and qualitatively. These acceptability questions were asked only of caregivers in the intervention group - Group 1 Supportive Care (Prepare to Care Kit). All data is based on participants answering the acceptability questions as &quot;Quite a Bit/Very Much Helpful&quot; for the intervention materials. Not all participants answered this part of the outcome measure.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Introductory DVD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Meetings with study interventionist</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relaxation CD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weekly text reminders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weekly email reminders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Study website</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinic iPads</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cancer Education workbook</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Utilizing Resources workbook</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Managing Time workbook</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Seeking/Accepting Support workbook</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Communicating with Others workbook</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Healthy Behaviors workbook</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Positive Coping workbook</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Muscle Relaxation workbook</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Accrual Assessed by Number of Caregivers Who Agreed to Participate Divided by the Number of Months of Recruitment</title>
        <description>38 patient/caregiver dyads agreed to participate, 22 months of recruitment, for accrual rate of 1.7 (caregiver) participants per month</description>
        <time_frame>Up to 1 year</time_frame>
        <population>38 patient/caregiver dyads agreed to participate, 22 months of recruitment, for accrual rate of 1.7 (caregiver) participants per month</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.&#xD;
Communication Intervention: Attend interventionist sessions&#xD;
Watch video: Watch video on a DVD&#xD;
Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Survey Administration: Ancillary studies&#xD;
Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.</description>
          </group>
        </group_list>
        <measure>
          <title>Accrual Assessed by Number of Caregivers Who Agreed to Participate Divided by the Number of Months of Recruitment</title>
          <description>38 patient/caregiver dyads agreed to participate, 22 months of recruitment, for accrual rate of 1.7 (caregiver) participants per month</description>
          <population>38 patient/caregiver dyads agreed to participate, 22 months of recruitment, for accrual rate of 1.7 (caregiver) participants per month</population>
          <units>participants/months</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA)</title>
        <description>21-item instrument assessing positive and negative aspects of caregiving (esteem, lack of family support, finances, schedule, and health). The CRA has been tested in cancer caregivers; demonstrated validity and reliability. Minimum and maximum scoring scale: BASELINE: Scores for esteem 15-31; lack of family support 5-15, impact of finances 3-12, impact of schedule 12-23, impact of health 11-16). AFTER RADIOTHERAPY: Scores for esteem 20-31; lack of family support 9-17, impact of finances 7-11, impact of schedule 14-22, impact of health 12-17). The higher the score the more the item being assessed impacted the participant.</description>
        <time_frame>Baseline and following radiotherapy, assessed up to 1 year</time_frame>
        <population>Not all participants submitted information after completion of radiotherapy.</population>
        <group_list>
          <group group_id="O1">
            <title>Group I Supportive Care (Prepare to Care Kit)</title>
            <description>Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.&#xD;
Communication Intervention: Attend interventionist sessions&#xD;
Watch video: Watch video on a DVD&#xD;
Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Survey Administration: Ancillary studies&#xD;
Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.</description>
          </group>
          <group group_id="O2">
            <title>Group II No Interventionist Sessions</title>
            <description>Caregivers receive educational intervention as in Group I but do not attend interventionist sessions&#xD;
Watch video: Watch video on a DVD&#xD;
Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Survey Administration: Ancillary studies&#xD;
Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA)</title>
          <description>21-item instrument assessing positive and negative aspects of caregiving (esteem, lack of family support, finances, schedule, and health). The CRA has been tested in cancer caregivers; demonstrated validity and reliability. Minimum and maximum scoring scale: BASELINE: Scores for esteem 15-31; lack of family support 5-15, impact of finances 3-12, impact of schedule 12-23, impact of health 11-16). AFTER RADIOTHERAPY: Scores for esteem 20-31; lack of family support 9-17, impact of finances 7-11, impact of schedule 14-22, impact of health 12-17). The higher the score the more the item being assessed impacted the participant.</description>
          <population>Not all participants submitted information after completion of radiotherapy.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Esteem at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.98" spread="3.6"/>
                    <measurement group_id="O2" value="25.88" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lack of family support at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.29" spread="2.69"/>
                    <measurement group_id="O2" value="11.25" spread="2.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Impact on finances at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.29" spread="2.28"/>
                    <measurement group_id="O2" value="8.89" spread="1.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Impact on schedule at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.35" spread="3.31"/>
                    <measurement group_id="O2" value="16.78" spread="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Impact on health at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.94" spread="1.48"/>
                    <measurement group_id="O2" value="13.67" spread="1.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Esteem after radiotherapy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.75" spread="3.31"/>
                    <measurement group_id="O2" value="25.30" spread="4.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lack of family support after radiotherapy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.58" spread="2.23"/>
                    <measurement group_id="O2" value="11.19" spread="3.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Impact on finances after radiotherapy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.42" spread="1.16"/>
                    <measurement group_id="O2" value="8.25" spread="1.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Impact on schedule after radiotherapy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.33" spread="2.74"/>
                    <measurement group_id="O2" value="16.56" spread="4.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Impact on health after radiotherapy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.33" spread="1.61"/>
                    <measurement group_id="O2" value="14.38" spread="1.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Psychological Distress - Center for Epidemiological Studies Depression (CESD)</title>
        <description>The score is the sum of the 20 questions. Possible scoring range is 0-60. A score of 16 points or more is considered depressed.</description>
        <time_frame>Before and after radiotherapy, assessed up to 1 year</time_frame>
        <population>Not all participants completed this intervention after radiotherapy timeframe indicated for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Group I Supportive Care (Prepare to Care Kit)</title>
            <description>Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.&#xD;
Communication Intervention: Attend interventionist sessions&#xD;
Watch video: Watch video on a DVD&#xD;
Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Survey Administration: Ancillary studies&#xD;
Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.</description>
          </group>
          <group group_id="O2">
            <title>Group II No Interventionist Sessions</title>
            <description>Caregivers receive educational intervention as in Group I but do not attend interventionist sessions&#xD;
Watch video: Watch video on a DVD&#xD;
Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Survey Administration: Ancillary studies&#xD;
Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Psychological Distress - Center for Epidemiological Studies Depression (CESD)</title>
          <description>The score is the sum of the 20 questions. Possible scoring range is 0-60. A score of 16 points or more is considered depressed.</description>
          <population>Not all participants completed this intervention after radiotherapy timeframe indicated for this outcome measure</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Score at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.71" spread="13.05"/>
                    <measurement group_id="O2" value="19.28" spread="12.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Score after radiotherapy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.00" spread="15.66"/>
                    <measurement group_id="O2" value="13.58" spread="8.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc)</title>
        <description>35-item instrument assessing dimensions of caregiver quality of life (burden, disruptiveness, positive adaptation, financial concerns). The Cqol-Canc has demonstrated validity and reliability. Minimum and maximum score at baseline is a range of 9-78 and after radiotherapy a range of 2-73. The higher the score the greater the level of change in the quality of life for participants.</description>
        <time_frame>Before and after radiotherapy, assessed up to 1 year</time_frame>
        <population>Not all participants completed this intervention after radiotherapy as indicated for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Group I Supportive Care (Prepare to Care Kit)</title>
            <description>Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.&#xD;
Communication Intervention: Attend interventionist sessions&#xD;
Watch video: Watch video on a DVD&#xD;
Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Survey Administration: Ancillary studies&#xD;
Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.</description>
          </group>
          <group group_id="O2">
            <title>Group II No Interventionist Sessions</title>
            <description>Caregivers receive educational intervention as in Group I but do not attend interventionist sessions&#xD;
Watch video: Watch video on a DVD&#xD;
Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Survey Administration: Ancillary studies&#xD;
Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc)</title>
          <description>35-item instrument assessing dimensions of caregiver quality of life (burden, disruptiveness, positive adaptation, financial concerns). The Cqol-Canc has demonstrated validity and reliability. Minimum and maximum score at baseline is a range of 9-78 and after radiotherapy a range of 2-73. The higher the score the greater the level of change in the quality of life for participants.</description>
          <population>Not all participants completed this intervention after radiotherapy as indicated for this outcome measure.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.63" spread="25.95"/>
                    <measurement group_id="O2" value="87.26" spread="20.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After radiotherapy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.55" spread="22.09"/>
                    <measurement group_id="O2" value="89.86" spread="18.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Frequency of Intervention Modules Utilized Assessed by Caregiver Logs</title>
        <description>Data on intervention resources used and time spent using them based on caregivers in intervention group</description>
        <time_frame>Up to 1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group I Supportive Care (Prepare to Care Kit)</title>
            <description>Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.&#xD;
Communication Intervention: Attend interventionist sessions&#xD;
Watch video: Watch video on a DVD&#xD;
Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Survey Administration: Ancillary studies&#xD;
Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Intervention Modules Utilized Assessed by Caregiver Logs</title>
          <description>Data on intervention resources used and time spent using them based on caregivers in intervention group</description>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cancer Education</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.3" spread="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Utilizing Resources</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.7" spread="20.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Seeking/ Accepting Support</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.2" spread="27.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Communicating with others</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.3" spread="12.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Managing Time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.8" spread="26.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Coping</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.7" spread="51.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Practicing Healthy Behaviors</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48" spread="15.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relaxation CD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58" spread="18.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants in Agreement to Perform Interventions</title>
        <description>Participation assessed by number of eligible participants who agreed to participate and complete study interventions.</description>
        <time_frame>Up to 1 year</time_frame>
        <population>90 eligible patient/caregiver dyads, 38 agreed to participate</population>
        <group_list>
          <group group_id="O1">
            <title>Combination of Intervention and Control Groups to Assess Participation</title>
            <description>Participation assessed by proportion of eligible participants who agreed to participate</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants in Agreement to Perform Interventions</title>
          <description>Participation assessed by number of eligible participants who agreed to participate and complete study interventions.</description>
          <population>90 eligible patient/caregiver dyads, 38 agreed to participate</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Retention Assessed by Number of Participants Who Completed the End of Radiotherapy Visit Divided by the Number Who Agreed to Participate</title>
        <time_frame>Up to 1 year</time_frame>
        <population>38 agreed to participate (19 in caregiver intervention group, 19 in caregiver control group)</population>
        <group_list>
          <group group_id="O1">
            <title>Group I Supportive Care (Prepare to Care Kit)</title>
            <description>Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.&#xD;
Communication Intervention: Attend interventionist sessions&#xD;
Watch video: Watch video on a DVD&#xD;
Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Survey Administration: Ancillary studies&#xD;
Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.</description>
          </group>
          <group group_id="O2">
            <title>Group II No Interventionist Sessions</title>
            <description>Caregivers receive educational intervention as in Group I but do not attend interventionist sessions&#xD;
Watch video: Watch video on a DVD&#xD;
Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Survey Administration: Ancillary studies&#xD;
Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.</description>
          </group>
        </group_list>
        <measure>
          <title>Retention Assessed by Number of Participants Who Completed the End of Radiotherapy Visit Divided by the Number Who Agreed to Participate</title>
          <population>38 agreed to participate (19 in caregiver intervention group, 19 in caregiver control group)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Self-efficacy in Abbreviated Progressive Muscle Relaxation (APMR)</title>
        <description>A 3-item instrument developed for study to evaluate self-efficacy in APMR. Minimum to maximum scores range from 3-27. Higher scores demonstrate higher self efficacy in participants.</description>
        <time_frame>At baseline and up to the end of radiotherapy, assessed up to 1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group I Supportive Care (Prepare to Care Kit)</title>
            <description>Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.&#xD;
Communication Intervention: Attend interventionist sessions&#xD;
Watch video: Watch video on a DVD&#xD;
Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Survey Administration: Ancillary studies&#xD;
Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.</description>
          </group>
          <group group_id="O2">
            <title>Group II No Interventionist Sessions</title>
            <description>Caregivers receive educational intervention as in Group I but do not attend interventionist sessions&#xD;
Watch video: Watch video on a DVD&#xD;
Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Survey Administration: Ancillary studies&#xD;
Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-efficacy in Abbreviated Progressive Muscle Relaxation (APMR)</title>
          <description>A 3-item instrument developed for study to evaluate self-efficacy in APMR. Minimum to maximum scores range from 3-27. Higher scores demonstrate higher self efficacy in participants.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.88" spread="6.53"/>
                    <measurement group_id="O2" value="13.33" spread="5.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After radiotherapy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.08" spread="2.68"/>
                    <measurement group_id="O2" value="12.19" spread="5.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Self-efficacy in Coping With Cancer Caregiver Inventory</title>
        <description>21-item instrument assessing caregivers' perceived self-efficacy for coping with cancer (managing medical information, caring for care recipient, caring for oneself, managing difficult interactions/emotions); demonstrated validity and reliability. Minimum and maximum scores range from 10-63. Higher scores indicate higher self-efficacy in coping with cancer from the participants.</description>
        <time_frame>At baseline and up to the end of radiotherapy, assessed up to 1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group I Supportive Care (Prepare to Care Kit)</title>
            <description>Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.&#xD;
Communication Intervention: Attend interventionist sessions&#xD;
Watch video: Watch video on a DVD&#xD;
Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Survey Administration: Ancillary studies&#xD;
Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.</description>
          </group>
          <group group_id="O2">
            <title>Group II No Interventionist Sessions</title>
            <description>Caregivers receive educational intervention as in Group I but do not attend interventionist sessions&#xD;
Watch video: Watch video on a DVD&#xD;
Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Survey Administration: Ancillary studies&#xD;
Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-efficacy in Coping With Cancer Caregiver Inventory</title>
          <description>21-item instrument assessing caregivers' perceived self-efficacy for coping with cancer (managing medical information, caring for care recipient, caring for oneself, managing difficult interactions/emotions); demonstrated validity and reliability. Minimum and maximum scores range from 10-63. Higher scores indicate higher self-efficacy in coping with cancer from the participants.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Managing medical information at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.35" spread="3.26"/>
                    <measurement group_id="O2" value="22.00" spread="3.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caring for care recipient at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.94" spread="9.65"/>
                    <measurement group_id="O2" value="55.11" spread="6.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caring for oneself at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.71" spread="10.44"/>
                    <measurement group_id="O2" value="28.06" spread="7.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Managing difficult interactions/emotions at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.52" spread="10.96"/>
                    <measurement group_id="O2" value="39.13" spread="7.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Managing medical information after radiotherapy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.08" spread="2.54"/>
                    <measurement group_id="O2" value="22.43" spread="4.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caring for care recipient after radiotherapy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.42" spread="5.62"/>
                    <measurement group_id="O2" value="54.98" spread="6.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caring for oneself after radiotherapy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.75" spread="9.40"/>
                    <measurement group_id="O2" value="31.30" spread="8.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Managing difficult interactions/emotions after radiotherapy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.92" spread="10.03"/>
                    <measurement group_id="O2" value="39.68" spread="7.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Salivary Cortisol Collection</title>
        <description>For eligible caregivers only - collected three times a day (at awakening, 30 minutes post-awakening, and bedtime) for two consecutive days following T1 (start of radiation), T2 (end of radiation), and T3 (6 weeks post radiation). To obtain preliminary data on caregiver cortisol response (cortisol slope, cortisol awakening response, area under the curve, and intra-individual cortisol variability). Investigators will use a mixed model to evaluate differences between the groups in these parameters at times T1 and T2 and T3</description>
        <time_frame>Up to 1 year</time_frame>
        <population>Analysis of this outcome measure is currently incomplete and cannot be reported as this time as the information is not available.</population>
        <group_list>
          <group group_id="O1">
            <title>Group I Supportive Care (Prepare to Care Kit)</title>
            <description>Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.&#xD;
Communication Intervention: Attend interventionist sessions&#xD;
Watch video: Watch video on a DVD&#xD;
Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Survey Administration: Ancillary studies&#xD;
Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.</description>
          </group>
          <group group_id="O2">
            <title>Group II Control Group</title>
            <description>Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study&#xD;
Watch video: Watch video on a DVD&#xD;
Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Survey Administration: Ancillary studies&#xD;
Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.</description>
          </group>
        </group_list>
        <measure>
          <title>Salivary Cortisol Collection</title>
          <description>For eligible caregivers only - collected three times a day (at awakening, 30 minutes post-awakening, and bedtime) for two consecutive days following T1 (start of radiation), T2 (end of radiation), and T3 (6 weeks post radiation). To obtain preliminary data on caregiver cortisol response (cortisol slope, cortisol awakening response, area under the curve, and intra-individual cortisol variability). Investigators will use a mixed model to evaluate differences between the groups in these parameters at times T1 and T2 and T3</description>
          <population>Analysis of this outcome measure is currently incomplete and cannot be reported as this time as the information is not available.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Group I Supportive Care (Prepare to Care Kit)</title>
          <description>Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.&#xD;
Communication Intervention: Attend interventionist sessions&#xD;
Watch video: Watch video on a DVD&#xD;
Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Survey Administration: Ancillary studies&#xD;
Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.</description>
        </group>
        <group group_id="E2">
          <title>Group II Control Group</title>
          <description>Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study.&#xD;
Watch video: Watch video on a DVD&#xD;
Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Survey Administration: Ancillary studies&#xD;
Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Principal Investigator</name_or_title>
      <organization>Wake Forest Baptist Comprehensive Cancer Center</organization>
      <phone>336-713-1432</phone>
      <email>cnightin@wakehealth.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03032250
org study id: IRB00038084
secondary id: NCI-2016-02045
secondary id: CCCWFU 99616
secondary id: P30CA012197
secondary id: R03CA208560
nct id: NCT03032250
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This pilot clinical trial studies how well Prepare to Care kit works in improving caregiver
      support in patients with stage I-IV head and neck cancer that is new or has come back.
      Prepare to Care kit may increase knowledge about head and neck cancer and enhance
      stress-management skills.
PRIMARY OBJECTIVES:

      I. To assess feasibility (accrual, participation, and retention) and acceptability of a
      supported self-management intervention for psycho-education and stress management skills
      building designed for informal caregivers (intervention group n=20; waitlist control group,
      n=20) of head and neck cancer (HNC) patients undergoing radiotherapy (RT).

      II. To obtain preliminary data on caregiver intermediate (self-efficacy for [a] coping with
      cancer and [b] abbreviated progressive muscle relaxation) and outcome variables (burden,
      psychological distress, quality of life) in intervention caregivers and waitlist control
      caregivers at the start of radiation (T1), end of radiation (T2), and 6-weeks post-radiation
      (T3).

      III. To compare intermediate (self-efficacy for (a) coping with cancer and (b) abbreviated
      progressive muscle relaxation) and outcome variables (burden, psychological distress, quality
      of life) between intervention caregivers and waitlist control caregivers at T1, T2, and T3.

      IV. To obtain preliminary data on caregiver cortisol response (cortisol slope, cortisol
      awakening

      OUTLINE: Patients are randomized to 1 of 2 groups.

      GROUP I: Caregivers watch introduction video on a digital video disc (DVD) over 10 minutes at
      baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at
      least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session
      over 10-30 minutes weekly.

      GROUP II: Caregivers receive educational intervention as in Group I but do not attend
      interventionist sessions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions
time frame: Six weeks post radiation therapy
description: 10-item quantitative survey will be developed for study to assess how much caregivers liked different aspects of the intervention. Acceptability will be summarized quantitatively and qualitatively. These acceptability questions were asked only of caregivers in the intervention group - Group 1 Supportive Care (Prepare to Care Kit). All data is based on participants answering the acceptability questions as "Quite a Bit/Very Much Helpful" for the intervention materials. Not all participants answered this part of the outcome measure.
measure: Accrual Assessed by Number of Caregivers Who Agreed to Participate Divided by the Number of Months of Recruitment
time frame: Up to 1 year
description: 38 patient/caregiver dyads agreed to participate, 22 months of recruitment, for accrual rate of 1.7 (caregiver) participants per month
measure: Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA)
time frame: Baseline and following radiotherapy, assessed up to 1 year
description: 21-item instrument assessing positive and negative aspects of caregiving (esteem, lack of family support, finances, schedule, and health). The CRA has been tested in cancer caregivers; demonstrated validity and reliability. Minimum and maximum scoring scale: BASELINE: Scores for esteem 15-31; lack of family support 5-15, impact of finances 3-12, impact of schedule 12-23, impact of health 11-16). AFTER RADIOTHERAPY: Scores for esteem 20-31; lack of family support 9-17, impact of finances 7-11, impact of schedule 14-22, impact of health 12-17). The higher the score the more the item being assessed impacted the participant.
measure: Change in Psychological Distress - Center for Epidemiological Studies Depression (CESD)
time frame: Before and after radiotherapy, assessed up to 1 year
description: The score is the sum of the 20 questions. Possible scoring range is 0-60. A score of 16 points or more is considered depressed.
measure: Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc)
time frame: Before and after radiotherapy, assessed up to 1 year
description: 35-item instrument assessing dimensions of caregiver quality of life (burden, disruptiveness, positive adaptation, financial concerns). The Cqol-Canc has demonstrated validity and reliability. Minimum and maximum score at baseline is a range of 9-78 and after radiotherapy a range of 2-73. The higher the score the greater the level of change in the quality of life for participants.
measure: Frequency of Intervention Modules Utilized Assessed by Caregiver Logs
time frame: Up to 1 year
description: Data on intervention resources used and time spent using them based on caregivers in intervention group
measure: Number of Participants in Agreement to Perform Interventions
time frame: Up to 1 year
description: Participation assessed by number of eligible participants who agreed to participate and complete study interventions.
measure: Retention Assessed by Number of Participants Who Completed the End of Radiotherapy Visit Divided by the Number Who Agreed to Participate
time frame: Up to 1 year
measure: Self-efficacy in Abbreviated Progressive Muscle Relaxation (APMR)
time frame: At baseline and up to the end of radiotherapy, assessed up to 1 year
description: A 3-item instrument developed for study to evaluate self-efficacy in APMR. Minimum to maximum scores range from 3-27. Higher scores demonstrate higher self efficacy in participants.
measure: Self-efficacy in Coping With Cancer Caregiver Inventory
time frame: At baseline and up to the end of radiotherapy, assessed up to 1 year
description: 21-item instrument assessing caregivers' perceived self-efficacy for coping with cancer (managing medical information, caring for care recipient, caring for oneself, managing difficult interactions/emotions); demonstrated validity and reliability. Minimum and maximum scores range from 10-63. Higher scores indicate higher self-efficacy in coping with cancer from the participants.
measure: Salivary Cortisol Collection
time frame: Up to 1 year
description: For eligible caregivers only - collected three times a day (at awakening, 30 minutes post-awakening, and bedtime) for two consecutive days following T1 (start of radiation), T2 (end of radiation), and T3 (6 weeks post radiation). To obtain preliminary data on caregiver cortisol response (cortisol slope, cortisol awakening response, area under the curve, and intra-individual cortisol variability). Investigators will use a mixed model to evaluate differences between the groups in these parameters at times T1 and T2 and T3
arm group label: Group I Supportive Care (Prepare to Care kit)
arm group type: Experimental
description: Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.
arm group label: Group II Control Group
arm group type: Experimental
description: Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study
intervention type: Other
intervention name: Communication Intervention
description: Attend interventionist sessions
arm group label: Group I Supportive Care (Prepare to Care kit)
intervention type: Other
intervention name: Watch video
description: Watch video on a DVD
arm group label: Group I Supportive Care (Prepare to Care kit)
arm group label: Group II Control Group
other name: Education for Intervention
other name: Intervention by Education
other name: Intervention through Education
other name: Intervention, Educational
intervention type: Other
intervention name: Module completion of the Prepare to Care kit
description: Complete modules of the Prepare to Care kit
arm group label: Group I Supportive Care (Prepare to Care kit)
arm group label: Group II Control Group
other name: Education for Intervention
other name: Intervention by Education
other name: Intervention through Education
other name: Intervention, Educational
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Group I Supportive Care (Prepare to Care kit)
arm group label: Group II Control Group
other name: Quality of Life Assessment
intervention type: Other
intervention name: Survey Administration
description: Ancillary studies
arm group label: Group I Supportive Care (Prepare to Care kit)
arm group label: Group II Control Group
intervention type: Other
intervention name: Salivary cortisol collection
description: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.
arm group label: Group I Supportive Care (Prepare to Care kit)
arm group label: Group II Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Chandylen Nightingale
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Head and Neck Neoplasms
mesh term: Squamous Cell Carcinoma of Head and Neck
mesh term: Recurrence
mesh term: Hydrocortisone
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 