<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/NCT02192333</url>
  </required_header>
  <id_info>
    <org_study_id>9161</org_study_id>
    <secondary_id>NCI-2014-01325</secondary_id>
    <secondary_id>9161</secondary_id>
    <secondary_id>P30CA015704</secondary_id>
    <secondary_id>RG1001123</secondary_id>
    <nct_id>NCT02192333</nct_id>
  </id_info>
  <brief_title>Survivorship Care in Reducing Symptoms in Young Adult Cancer Survivors</brief_title>
  <official_title>Young Adult Cancer Survivor Network Study of the Essential Elements of Care (YA-EEC-14)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fred Hutchinson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Livestrong Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Fred Hutchinson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized clinical trial studies survivorship care in reducing symptoms in young adult&#xD;
      cancer survivors. Survivorship care programs that identify the needs of young adult cancer&#xD;
      survivors and ways to support them through the years after treatment may help reduce&#xD;
      symptoms, such as pain, fatigue, sleep disturbance, depression, and distress, in young adult&#xD;
      cancer survivors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To test the impact of providing the essential elements of survivorship care on&#xD;
      survivorship outcomes as indicated by reduction in symptoms (pain, fatigue, sleep&#xD;
      disturbance, depression, distress) in young adult cancer survivors diagnosed with cancer&#xD;
      between the ages of 18 and 39 years when compared with usual care.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To improve confidence in survivorship knowledge and promote healthy lifestyle behaviors.&#xD;
&#xD;
      II. To provide evidence on barriers, needs and care preferences that will support long term&#xD;
      follow-up recommendations for this population.&#xD;
&#xD;
      OUTLINE: Participants categorized as high-need are randomized to 1 of 2 arms. Participants&#xD;
      categorized as low-need are assigned to Arm I.&#xD;
&#xD;
      ARM I: Participants receive usual care. After 12 months, participants may receive a&#xD;
      survivorship clinic visit and boosters as in Arm II.&#xD;
&#xD;
      ARM II: Participants attend a survivorship clinic visit that includes care plans, screening&#xD;
      recommendations, physician coordination, health promotion education, symptom management and&#xD;
      palliative care, late effects education, psychosocial and medical assessments, and referrals&#xD;
      for services and care as appropriate. Participants also receive phone-based survivorship&#xD;
      boosters over approximately 15-30 minutes at 4-8 weeks and 12-16 weeks after the initial&#xD;
      clinic visit.&#xD;
&#xD;
      After completion of study, participants are followed up at 6 and 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 3, 2015</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">October 7, 2017</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>Mean of the two z scores of the two highest scores for the symptoms that determined the participant's eligibility as &quot;high need&quot; assessed using patient-reported outcomes (PRO) survey</measure>
    <time_frame>At 6 months</time_frame>
    <description>Mean scores for the primary outcome measures will be compared between the study using standard methods. Two-sided significance levels will be set at an alpha level of 0.05.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Barriers to health care assessed using the patient-reported outcomes (PRO) survey</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in depression assessed using the patient-reported outcomes (PRO) survey</measure>
    <time_frame>Baseline to up to 12 months</time_frame>
    <description>Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available. The mean differences in other continuous valued outcomes will be evaluated using standard t-tests or linear regression models, as appropriate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in distress assessed using the patient-reported outcomes (PRO) survey</measure>
    <time_frame>Baseline to up to 12 months</time_frame>
    <description>Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available. The mean differences in other continuous valued outcomes will be evaluated using standard t-tests or linear regression models, as appropriate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fatigue assessed using the patient-reported outcomes (PRO) survey</measure>
    <time_frame>Baseline to up to 12 months</time_frame>
    <description>Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available. The mean differences in other continuous valued outcomes will be evaluated using standard t-tests or linear regression models, as appropriate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pain assessed using the patient-reported outcomes (PRO) survey</measure>
    <time_frame>Baseline to up to 12 months</time_frame>
    <description>Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available. The mean differences in other continuous valued outcomes will be evaluated using standard t-tests or linear regression models, as appropriate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sleep assessed using the patient-reported outcomes (PRO) survey</measure>
    <time_frame>Baseline to up to 12 months</time_frame>
    <description>Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available. The mean differences in other continuous valued outcomes will be evaluated using standard t-tests or linear regression models, as appropriate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Confidence in survivorship information assessed using the patient-reported outcomes (PRO) survey</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General health assessed using the patient-reported outcomes (PRO) survey</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health behaviors assessed using the patient-reported outcomes (PRO) survey</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care utilization assessed using the patient-reported outcomes (PRO) survey</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medications assessed using the patient-reported outcomes (PRO) survey</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood and worries assessed using the patient-reported outcomes (PRO) survey</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Musculoskeletal symptoms assessed using the patient-reported outcomes (PRO) survey</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropathy assessed using the patient-reported outcomes (PRO) survey</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-traumatic stress assessed using the patient-reported outcomes (PRO) survey</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessed using the patient-reported outcomes (PRO) survey</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reclassification of subject from high need to low need</measure>
    <time_frame>At 6 months</time_frame>
    <description>Reclassification of subject from high need to low need is defined as the high need subject no longer has scores above the cut-off level on 2 or more symptoms scales (depression, distress, insomnia, fatigue, pain) assessed using the PRO survey. The 5 symptom scales are categorized based on the following cut points to define &quot;high need&quot;: pain score &gt;= 5, fatigue score &gt;= 3, insomnia score of no insomnia, distress score &gt; 1.1, and depression score &gt;= 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reproductive health assessed using the patient-reported outcomes (PRO) survey</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual function assessed using the patient-reported outcomes (PRO) survey</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social support assessed using the patient-reported outcomes (PRO) survey</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">390</enrollment>
  <condition>Breast Carcinoma</condition>
  <condition>Cancer Survivor</condition>
  <condition>Depression</condition>
  <condition>Fatigue</condition>
  <condition>Leukemia</condition>
  <condition>Lymphoma</condition>
  <condition>Malignant Bone Neoplasm</condition>
  <condition>Malignant Digestive System Neoplasm</condition>
  <condition>Malignant Female Reproductive System Neoplasm</condition>
  <condition>Malignant Male Reproductive System Neoplasm</condition>
  <condition>Pain</condition>
  <condition>Sleep Disorder</condition>
  <condition>Soft Tissue Sarcoma</condition>
  <arm_group>
    <arm_group_label>Arm I (usual care)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants receive usual care. After 12 months, participants may receive a survivorship clinic visit and boosters as in Arm II.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (survivorship care)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants attend a survivorship clinic visit that includes care plans, screening recommendations, physician coordination, health promotion education, symptom management and palliative care, late effects education, psychosocial and medical assessments, and referrals for services and care as appropriate. Participants also receive phone-based survivorship boosters over approximately 15-30 minutes at 4-8 weeks and 12-16 weeks after the initial clinic visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Management of Therapy Complications</intervention_name>
    <description>Receive survivorship care</description>
    <arm_group_label>Arm II (survivorship care)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm II (survivorship care)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm II (survivorship care)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telephone-Based Intervention</intervention_name>
    <description>Receive phone-based booster intervention</description>
    <arm_group_label>Arm II (survivorship care)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients enrolled on phase 1 of the study are eligible (and/or if recruited from tumor&#xD;
             registry or clinic follow-up schedules)&#xD;
&#xD;
          -  Diagnosed with invasive malignancy including: breast, gastrointestinal track, female&#xD;
             or male genitourinary system, sarcoma of bone or soft-tissue, leukemia and lymphoma&#xD;
&#xD;
          -  Treated at one of the Survivorship Centers of Excellence or their community affiliates&#xD;
&#xD;
          -  Received a therapeutic intervention with at least one of the following modalities:&#xD;
             surgery, cytotoxic chemotherapy, biological or targeted agents, radiation therapy (any&#xD;
             modality)&#xD;
&#xD;
          -  Currently between 1.0 and 4.99 years from the completion of active cancer-directed&#xD;
             therapy (cytotoxic chemotherapy, radiation therapy and/or definitive surgical&#xD;
             intervention)&#xD;
&#xD;
          -  Patient must still be in active follow-up: seen for a follow-up visit in the&#xD;
             participating center at least once in the 3 years prior to enrollment and/or scheduled&#xD;
             to be seen for follow-up in the next 6 months (i.e. in active follow-up)&#xD;
&#xD;
          -  May be receiving &quot;maintenance&quot; therapy that has a goal of prevention of recurrence but&#xD;
             there should be no expectations for further active treatment&#xD;
&#xD;
          -  Able to read and speak English adequate to complete the patient-reported outcomes&#xD;
             (PRO) assessment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior visit to a survivorship clinic or previously provided with a treatment summary&#xD;
             and care plan&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>K. Scott Baker</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fred Hutch/University of Washington Cancer Consortium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA / Jonsson Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Cancer Center - Anschutz Cancer Pavilion</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UNC Lineberger Comprehensive Cancer Center</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania/Abramson Cancer Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fred Hutch/University of Washington Cancer Consortium</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>October 8, 2020</last_update_submitted>
  <last_update_submitted_qc>October 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2020</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>Neoplasms</mesh_term>
    <mesh_term>Sarcoma</mesh_term>
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Digestive System Neoplasms</mesh_term>
    <mesh_term>Gastrointestinal Neoplasms</mesh_term>
    <mesh_term>Genital Neoplasms, Female</mesh_term>
    <mesh_term>Bone Neoplasms</mesh_term>
    <mesh_term>Genital Neoplasms, Male</mesh_term>
    <mesh_term>Sleep Wake Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02192333
org study id: 9161
secondary id: NCI-2014-01325
secondary id: 9161
secondary id: P30CA015704
secondary id: RG1001123
nct id: NCT02192333
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This randomized clinical trial studies survivorship care in reducing symptoms in young adult
      cancer survivors. Survivorship care programs that identify the needs of young adult cancer
      survivors and ways to support them through the years after treatment may help reduce
      symptoms, such as pain, fatigue, sleep disturbance, depression, and distress, in young adult
      cancer survivors.
PRIMARY OBJECTIVES:

      I. To test the impact of providing the essential elements of survivorship care on
      survivorship outcomes as indicated by reduction in symptoms (pain, fatigue, sleep
      disturbance, depression, distress) in young adult cancer survivors diagnosed with cancer
      between the ages of 18 and 39 years when compared with usual care.

      SECONDARY OBJECTIVES:

      I. To improve confidence in survivorship knowledge and promote healthy lifestyle behaviors.

      II. To provide evidence on barriers, needs and care preferences that will support long term
      follow-up recommendations for this population.

      OUTLINE: Participants categorized as high-need are randomized to 1 of 2 arms. Participants
      categorized as low-need are assigned to Arm I.

      ARM I: Participants receive usual care. After 12 months, participants may receive a
      survivorship clinic visit and boosters as in Arm II.

      ARM II: Participants attend a survivorship clinic visit that includes care plans, screening
      recommendations, physician coordination, health promotion education, symptom management and
      palliative care, late effects education, psychosocial and medical assessments, and referrals
      for services and care as appropriate. Participants also receive phone-based survivorship
      boosters over approximately 15-30 minutes at 4-8 weeks and 12-16 weeks after the initial
      clinic visit.

      After completion of study, participants are followed up at 6 and 12 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Mean of the two z scores of the two highest scores for the symptoms that determined the participant's eligibility as "high need" assessed using patient-reported outcomes (PRO) survey
time frame: At 6 months
description: Mean scores for the primary outcome measures will be compared between the study using standard methods. Two-sided significance levels will be set at an alpha level of 0.05.
measure: Barriers to health care assessed using the patient-reported outcomes (PRO) survey
time frame: Up to 12 months
description: Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.
measure: Change in depression assessed using the patient-reported outcomes (PRO) survey
time frame: Baseline to up to 12 months
description: Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available. The mean differences in other continuous valued outcomes will be evaluated using standard t-tests or linear regression models, as appropriate.
measure: Change in distress assessed using the patient-reported outcomes (PRO) survey
time frame: Baseline to up to 12 months
description: Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available. The mean differences in other continuous valued outcomes will be evaluated using standard t-tests or linear regression models, as appropriate.
measure: Change in fatigue assessed using the patient-reported outcomes (PRO) survey
time frame: Baseline to up to 12 months
description: Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available. The mean differences in other continuous valued outcomes will be evaluated using standard t-tests or linear regression models, as appropriate.
measure: Change in pain assessed using the patient-reported outcomes (PRO) survey
time frame: Baseline to up to 12 months
description: Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available. The mean differences in other continuous valued outcomes will be evaluated using standard t-tests or linear regression models, as appropriate.
measure: Change in sleep assessed using the patient-reported outcomes (PRO) survey
time frame: Baseline to up to 12 months
description: Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available. The mean differences in other continuous valued outcomes will be evaluated using standard t-tests or linear regression models, as appropriate.
measure: Confidence in survivorship information assessed using the patient-reported outcomes (PRO) survey
time frame: Up to 12 months
description: Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.
measure: General health assessed using the patient-reported outcomes (PRO) survey
time frame: Up to 12 months
description: Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.
measure: Health behaviors assessed using the patient-reported outcomes (PRO) survey
time frame: Up to 12 months
description: Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.
measure: Health care utilization assessed using the patient-reported outcomes (PRO) survey
time frame: Up to 12 months
description: Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.
measure: Medications assessed using the patient-reported outcomes (PRO) survey
time frame: Up to 12 months
description: Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.
measure: Mood and worries assessed using the patient-reported outcomes (PRO) survey
time frame: Up to 12 months
description: Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.
measure: Musculoskeletal symptoms assessed using the patient-reported outcomes (PRO) survey
time frame: Up to 12 months
description: Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.
measure: Neuropathy assessed using the patient-reported outcomes (PRO) survey
time frame: Up to 12 months
description: Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.
measure: Post-traumatic stress assessed using the patient-reported outcomes (PRO) survey
time frame: Up to 12 months
description: Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.
measure: Quality of life assessed using the patient-reported outcomes (PRO) survey
time frame: Up to 12 months
description: Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.
measure: Reclassification of subject from high need to low need
time frame: At 6 months
description: Reclassification of subject from high need to low need is defined as the high need subject no longer has scores above the cut-off level on 2 or more symptoms scales (depression, distress, insomnia, fatigue, pain) assessed using the PRO survey. The 5 symptom scales are categorized based on the following cut points to define "high need": pain score >= 5, fatigue score >= 3, insomnia score of no insomnia, distress score > 1.1, and depression score >= 10.
measure: Reproductive health assessed using the patient-reported outcomes (PRO) survey
time frame: Up to 12 months
description: Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.
measure: Sexual function assessed using the patient-reported outcomes (PRO) survey
time frame: Up to 12 months
description: Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.
measure: Social support assessed using the patient-reported outcomes (PRO) survey
time frame: Up to 12 months
description: Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.
arm group label: Arm I (usual care)
arm group type: No Intervention
description: Participants receive usual care. After 12 months, participants may receive a survivorship clinic visit and boosters as in Arm II.
arm group label: Arm II (survivorship care)
arm group type: Experimental
description: Participants attend a survivorship clinic visit that includes care plans, screening recommendations, physician coordination, health promotion education, symptom management and palliative care, late effects education, psychosocial and medical assessments, and referrals for services and care as appropriate. Participants also receive phone-based survivorship boosters over approximately 15-30 minutes at 4-8 weeks and 12-16 weeks after the initial clinic visit.
intervention type: Procedure
intervention name: Management of Therapy Complications
description: Receive survivorship care
arm group label: Arm II (survivorship care)
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Arm II (survivorship care)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Arm II (survivorship care)
intervention type: Behavioral
intervention name: Telephone-Based Intervention
description: Receive phone-based booster intervention
arm group label: Arm II (survivorship care)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 39 Years
healthy volunteers: No
last name: K. Scott Baker
role: Principal Investigator
affiliation: Fred Hutch/University of Washington Cancer Consortium
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Sarcoma
mesh term: Breast Neoplasms
mesh term: Digestive System Neoplasms
mesh term: Gastrointestinal Neoplasms
mesh term: Genital Neoplasms, Female
mesh term: Bone Neoplasms
mesh term: Genital Neoplasms, Male
mesh term: Sleep Wake Disorders