<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/NCT04405115</url>
  </required_header>
  <id_info>
    <org_study_id>2019028</org_study_id>
    <nct_id>NCT04405115</nct_id>
  </id_info>
  <brief_title>Improving Survivorship Care for Older Adults After Chemotherapy</brief_title>
  <official_title>Improving Survivorship Care for Older Adults After Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</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>
      The researchers want to find out if older adults receiving a survivorship care plan followed&#xD;
      by a geriatric assessment visit improves quality of life and satisfaction with care compared&#xD;
      to receiving only a survivorship care plan for older adults who have completed chemotherapy&#xD;
      for cancer treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a pilot randomized trial to examine whether a geriatric assessment-enhanced&#xD;
      survivorship care plan improves satisfaction, knowledge and health-related quality of life&#xD;
      compared to standard survivorship care plans among older adults who have completed curative&#xD;
      chemotherapy for cancer. The investigator's hypothesis is that older adults who receive a&#xD;
      geriatric assessment-enhanced survivorship care plan will report improved satisfaction with&#xD;
      care, health-related quality of life, and knowledge and preparedness for survivorship care&#xD;
      needs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 16, 2021</start_date>
  <completion_date type="Anticipated">May 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">May 30, 2025</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>
    <intervention_model_description>2 arms; 1:1 randomization;&#xD;
Standard of care (control group) will receive routine care only and will not be scheduled for a Comprehensive Geriatric Assessments visit.&#xD;
Comprehensive geriatric assessment ( intervention group) will be scheduled for a Comprehensive Geriatric Assessment visit that will take place with a geriatric nurse practitioner of a physician as soon as possible following enrollment and randomization (preferably within 2 weeks).</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Study retention rate</measure>
    <time_frame>4-6 months</time_frame>
    <description>Feasibility of the study will be assessed by study retention rate which is defined as proportion of enrolled participants who remain enrolled until study completion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of months needed for completion of trial enrollment</measure>
    <time_frame>4-6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of the study: survey</measure>
    <time_frame>4-6 months</time_frame>
    <description>Assess acceptability via a short survey administered to participating oncology nurse navigators and patients selected for the intervention group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction assessment by PSCC (Patient Satisfaction with Cancer related Care) tool</measure>
    <time_frame>4-6 months</time_frame>
    <description>PSCC items are rated on 5-point Likert scales: &quot;1 = Strongly Agree&quot;, &quot;2 = Agree&quot;, &quot;3 = Neutral&quot;, &quot;4 = Disagree&quot;, and &quot;5 = Strongly Disagree&quot;. A lower PSCC total score indicates higher satisfaction level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life assessment by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire EORTC QLQ-30</measure>
    <time_frame>4-6 months</time_frame>
    <description>The QLQ-C30 questionnaire is a specific questionnaire for cancer, it is composed of 30 questions or items that assess the quality of life in relation to physical, emotional, social aspects and in general the level of functionality of patients diagnosed with cancer. The QLQ-C30 questionnaire is assigned values between 1 and 4 (1: not at all, 2: a little, 3: a lot, 4: a lot) according to the patient's responses to the item, only in items 29 and 30 are assessed with score from 1 to 7 (1: bad, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, 0 being the worst possible and 100 the best.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life assessment by QLQ14</measure>
    <time_frame>4-6 months</time_frame>
    <description>QLQ-ELD14 is a validated quality of life questionnaire for cancer patients aged ⩾70 years and it is used in conjunction with EORTC QLQ-30.QLQ-ELD14 comprises five scales (mobility, worries about others, future worries, maintaining purpose and burden of illness) and two single items (joint stiffness and family support)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self rated patient knowledge and preparedness measured by PLANS assessment tool (Preparing for Life as a New Survivor)</measure>
    <time_frame>4-6 months</time_frame>
    <description>Preparing for Life as a New Survivor (PLANS) survey is utilized to evaluate survivor satisfaction with 1) own knowledge of diagnosis, treatment, and side effects, and 2) communication with the cancer team regarding diagnosis, treatment, and side effects.PLANS questions assess the level of agreement with statements regarding satisfaction with a 4-point scale (strongly disagree, somewhat disagree, somewhat agree, strongly agree) for each statement.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Survivorship</condition>
  <arm_group>
    <arm_group_label>No intervention arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>routine care only; will not be scheduled for comprehensive geriatric assessment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active comparator arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>those that will be scheduled for comprehensive geriatric assessment with a geriatric nurse practitioner or physician</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Geriatric Assessment</intervention_name>
    <description>Geriatric Assessment Visit</description>
    <arm_group_label>Active comparator arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age 65 years and above and&#xD;
&#xD;
          2. Have diagnosis of cancer and have completed chemotherapy with curative (not&#xD;
             palliative) intent and&#xD;
&#xD;
          3. have been scheduled to receive a survivorship care plan from an oncology navigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. advanced dementia or serious cognitive impairment that would impede ability to&#xD;
             participate in the interview&#xD;
&#xD;
          2. nursing home resident.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Haifaa Abdulhaq, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Joseph Mosholder</last_name>
    <phone>559-387-1825</phone>
    <email>JMosholder@communitymedical.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Richard Ward</last_name>
    <phone>559-387-1828</phone>
    <email>RWard5@communitymedical.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Community Cancer Institute</name>
      <address>
        <city>Clovis</city>
        <state>California</state>
        <zip>93611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joseph Mosholder</last_name>
      <phone>559-387-1825</phone>
      <email>JMosholder@communitymedical.org</email>
    </contact>
    <contact_backup>
      <last_name>Richard Ward</last_name>
      <phone>559-387-1828</phone>
      <email>RWard5@communitymedical.org</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>March 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>April 6, 2023</last_update_submitted>
  <last_update_submitted_qc>April 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>survivorship care</keyword>
  <keyword>Chemo</keyword>
  <keyword>chemotherapy</keyword>
  <keyword>older</keyword>
  <keyword>survivor</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04405115
org study id: 2019028
nct id: NCT04405115
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The researchers want to find out if older adults receiving a survivorship care plan followed
      by a geriatric assessment visit improves quality of life and satisfaction with care compared
      to receiving only a survivorship care plan for older adults who have completed chemotherapy
      for cancer treatment.
This study is a pilot randomized trial to examine whether a geriatric assessment-enhanced
      survivorship care plan improves satisfaction, knowledge and health-related quality of life
      compared to standard survivorship care plans among older adults who have completed curative
      chemotherapy for cancer. The investigator's hypothesis is that older adults who receive a
      geriatric assessment-enhanced survivorship care plan will report improved satisfaction with
      care, health-related quality of life, and knowledge and preparedness for survivorship care
      needs.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 2 arms; 1:1 randomization;
Standard of care (control group) will receive routine care only and will not be scheduled for a Comprehensive Geriatric Assessments visit.
Comprehensive geriatric assessment ( intervention group) will be scheduled for a Comprehensive Geriatric Assessment visit that will take place with a geriatric nurse practitioner of a physician as soon as possible following enrollment and randomization (preferably within 2 weeks).
primary purpose: Supportive Care
masking: None (Open Label)
measure: Study retention rate
time frame: 4-6 months
description: Feasibility of the study will be assessed by study retention rate which is defined as proportion of enrolled participants who remain enrolled until study completion.
measure: Number of months needed for completion of trial enrollment
time frame: 4-6 months
measure: Acceptability of the study: survey
time frame: 4-6 months
description: Assess acceptability via a short survey administered to participating oncology nurse navigators and patients selected for the intervention group.
measure: Patient satisfaction assessment by PSCC (Patient Satisfaction with Cancer related Care) tool
time frame: 4-6 months
description: PSCC items are rated on 5-point Likert scales: "1 = Strongly Agree", "2 = Agree", "3 = Neutral", "4 = Disagree", and "5 = Strongly Disagree". A lower PSCC total score indicates higher satisfaction level
measure: Health related quality of life assessment by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire EORTC QLQ-30
time frame: 4-6 months
description: The QLQ-C30 questionnaire is a specific questionnaire for cancer, it is composed of 30 questions or items that assess the quality of life in relation to physical, emotional, social aspects and in general the level of functionality of patients diagnosed with cancer. The QLQ-C30 questionnaire is assigned values between 1 and 4 (1: not at all, 2: a little, 3: a lot, 4: a lot) according to the patient's responses to the item, only in items 29 and 30 are assessed with score from 1 to 7 (1: bad, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, 0 being the worst possible and 100 the best.
measure: Health related quality of life assessment by QLQ14
time frame: 4-6 months
description: QLQ-ELD14 is a validated quality of life questionnaire for cancer patients aged ⩾70 years and it is used in conjunction with EORTC QLQ-30.QLQ-ELD14 comprises five scales (mobility, worries about others, future worries, maintaining purpose and burden of illness) and two single items (joint stiffness and family support)
measure: Self rated patient knowledge and preparedness measured by PLANS assessment tool (Preparing for Life as a New Survivor)
time frame: 4-6 months
description: Preparing for Life as a New Survivor (PLANS) survey is utilized to evaluate survivor satisfaction with 1) own knowledge of diagnosis, treatment, and side effects, and 2) communication with the cancer team regarding diagnosis, treatment, and side effects.PLANS questions assess the level of agreement with statements regarding satisfaction with a 4-point scale (strongly disagree, somewhat disagree, somewhat agree, strongly agree) for each statement.
arm group label: No intervention arm
arm group type: No Intervention
description: routine care only; will not be scheduled for comprehensive geriatric assessment
arm group label: Active comparator arm
arm group type: Active Comparator
description: those that will be scheduled for comprehensive geriatric assessment with a geriatric nurse practitioner or physician
intervention type: Behavioral
intervention name: Geriatric Assessment
description: Geriatric Assessment Visit
arm group label: Active comparator arm
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Haifaa Abdulhaq, MD
role: Principal Investigator
affiliation: University of California, San Francisco
last name: Joseph Mosholder
phone: 559-387-1825
email: JMosholder@communitymedical.org
last name: Richard Ward
phone: 559-387-1828
email: RWard5@communitymedical.org
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
sharing ipd: No