<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/NCT04452825</url>
  </required_header>
  <id_info>
    <org_study_id>20-191</org_study_id>
    <nct_id>NCT04452825</nct_id>
  </id_info>
  <brief_title>A New Psychotherapy Intervention for Older Cancer Patients</brief_title>
  <official_title>Cancer and Aging Reflections for Elders (CARE): A Geriatric-Specific Psychotherapy for Older Adults With Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being done to see if a new psychotherapy intervention called Cancer and Aging:&#xD;
      Reflections for Elders (CARE) can effectively treat depression and distress in older cancer&#xD;
      patients. CARE is a 5-session intervention that takes place over the phone. This study will&#xD;
      compare CARE with the Social Work and Supportive Counseling (SWSC) intervention, which also&#xD;
      takes place over the phone. SWSC is a standard psychotherapeutic intervention that has been&#xD;
      shown to be a supportive and effective form of treatment for distress for patients with&#xD;
      cancer. The researchers will look at which intervention is more effective in treating&#xD;
      depression and distress in participants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2021</start_date>
  <completion_date type="Anticipated">June 2025</completion_date>
  <primary_completion_date type="Anticipated">June 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>This study is designed to test CARE delivered by telephone to improve cancer care for the population of older adults in a larger two-arm Randomized Controlled Trial (RCT).</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depression and Anxiety: Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>9 months</time_frame>
    <description>This 14-item scale, which has been well tested in cancer populations including elderly patients with cancer, has depression and anxiety subscales of seven items each. It is considered particularly useful for patients with chronic disease because of the absence of somatic items that often confound the determination of psychiatric problems among the medically ill.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">296</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Cancer and Aging: Reflections for Elders (CARE) Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Session content and timing was developed and confirmed in our qualitative work (Expert Panel) and the CARE pilot study. Five sessions (45-60 minutes each) will be delivered over an 8-week period (+4 weeks). Following these sessions, four brief booster sessions (20-30 minutes each) will be delivered at a rate of approximately one per month to extend the interventions to 6 months (+3 months).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Social Work and Supportive Counseling (SWSC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The SWSC will include a social work assessment and follow-up augmented with additional components of supportive psychotherapy that have been shown to be an effective form of treatment for patients with cancer. Five sessions (45-60 minutes each) will be delivered over an 8-week period (+4 weeks). Following these sessions, four brief booster sessions (20-30 minutes each) will be delivered at a rate of approximately one per month to extend the interventions to 6 months (+3 months).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cancer and Aging: Reflections for Elders (CARE) Intervention</intervention_name>
    <description>For full participants (not training case participants) five sessions (45-60 minutes each) will be delivered over an 8-week period (+4 weeks). Following these sessions, four brief booster sessions (20-30 minutes each) will be delivered at a rate of approximately one per month to extend the interventions to 6 months (+3 months).</description>
    <arm_group_label>Cancer and Aging: Reflections for Elders (CARE) Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Social Work and Supportive Counseling (SWSC) Intervention</intervention_name>
    <description>The SWSC will include a social work assessment and follow-up augmented with additional components of supportive psychotherapy that have been shown to be an effective form of treatment for patients with cancer. For full participants (not training case participants) five sessions (45-60 minutes each) will be delivered over an 8-week period (+4 weeks). Following these sessions, four brief booster sessions (20-30 minutes each) will be delivered at a rate of approximately one per month to extend the interventions to 6 months (+3 months). Training case participants will follow a slightly condensed schedule.</description>
    <arm_group_label>Social Work and Supportive Counseling (SWSC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  As per self-report or medical record, ≥ 70 years of age&#xD;
&#xD;
          -  As per self-report or medical record, has a diagnosis of cancer&#xD;
&#xD;
          -  As per self-report or medical record, receiving active treatment (e.g., radiation,&#xD;
             chemotherapy, hormone); OR received active treatment in the past 6 months (N/A for&#xD;
             training case participants); OR are currently on active surveillance with follow-ups&#xD;
             at least approximately every 6 months&#xD;
&#xD;
          -  Received a HADS-D score of ≥ 6 or HADS-A score of ≥ 6 or a score of ≥ 4 on the&#xD;
             distress thermometer. (N/A for training case participants)&#xD;
&#xD;
          -  Received a Karnofsky Performance Rating Scale (KPRS) score of ≥ 60 (N/A for training&#xD;
             case participants)&#xD;
&#xD;
          -  Received a Blessed Orientation-Memory-Concentration Scale (BOMC) score of ≤ 11 (N/A&#xD;
             for training case participants)&#xD;
&#xD;
          -  Fluent in English, as per self-reported fluency of &quot;well&quot; or &quot;very well&quot;*&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  As per self-report, currently taking antidepressant medication for &lt; 3 months&#xD;
&#xD;
          -  As per self-report, currently receiving hospice care&#xD;
&#xD;
          -  In the judgment of the consenting professional is unable to provide informed consent&#xD;
             and complete study sessions and assessment&#xD;
&#xD;
          -  As per self-report or as documented in the medical record, current untreated (e.g., no&#xD;
             medication, no therapy) major psychotic disorder (schizotypal personality disorder,&#xD;
             schizophreniform disorder, schizoaffective disorder). Patients diagnosed with a major&#xD;
             psychiatric disorder will be reviewed by the study PI to determine eligibility prior&#xD;
             to consent.&#xD;
&#xD;
               -  Language verification: Prior to enrollment, patients will be asked the following&#xD;
                  two questions by research staff to verify English fluency necessary for&#xD;
                  participation in the study:&#xD;
&#xD;
                    1. How well do you speak English? (must respond &quot;Well&quot; or &quot;Very well&quot; when&#xD;
                       given the choices of Very well, Well, Not well, Not at all, Don't know, or&#xD;
                       Refused)&#xD;
&#xD;
                    2. What is your preferred language for healthcare? (must respond English)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian Nelson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christian Nelson, PhD</last_name>
    <phone>646-888-0030</phone>
    <email>nelsonc@mskcc.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rebecca Saracino, PhD</last_name>
    <phone>646-888-0263</phone>
    <email>jamesr@mskcc.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christian Nelson, PhD</last_name>
      <phone>646-888-0030</phone>
    </contact>
    <contact_backup>
      <last_name>Rebecca Saracino, PhD</last_name>
      <phone>646-888-0263</phone>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>August 10, 2023</last_update_submitted>
  <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>geriatric cancer</keyword>
  <keyword>geriatric specific</keyword>
  <keyword>older adults with cancer</keyword>
  <keyword>Psychotherapy</keyword>
  <keyword>Memorial Sloan Kettering Cancer Center</keyword>
  <keyword>20-191</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.</ipd_description>
  </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/NCT04452825
org study id: 20-191
nct id: NCT04452825
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is being done to see if a new psychotherapy intervention called Cancer and Aging:
      Reflections for Elders (CARE) can effectively treat depression and distress in older cancer
      patients. CARE is a 5-session intervention that takes place over the phone. This study will
      compare CARE with the Social Work and Supportive Counseling (SWSC) intervention, which also
      takes place over the phone. SWSC is a standard psychotherapeutic intervention that has been
      shown to be a supportive and effective form of treatment for distress for patients with
      cancer. The researchers will look at which intervention is more effective in treating
      depression and distress in participants.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study is designed to test CARE delivered by telephone to improve cancer care for the population of older adults in a larger two-arm Randomized Controlled Trial (RCT).
primary purpose: Supportive Care
masking: None (Open Label)
measure: Depression and Anxiety: Hospital Anxiety and Depression Scale (HADS)
time frame: 9 months
description: This 14-item scale, which has been well tested in cancer populations including elderly patients with cancer, has depression and anxiety subscales of seven items each. It is considered particularly useful for patients with chronic disease because of the absence of somatic items that often confound the determination of psychiatric problems among the medically ill.
arm group label: Cancer and Aging: Reflections for Elders (CARE) Intervention
arm group type: Experimental
description: Session content and timing was developed and confirmed in our qualitative work (Expert Panel) and the CARE pilot study. Five sessions (45-60 minutes each) will be delivered over an 8-week period (+4 weeks). Following these sessions, four brief booster sessions (20-30 minutes each) will be delivered at a rate of approximately one per month to extend the interventions to 6 months (+3 months).
arm group label: Social Work and Supportive Counseling (SWSC)
arm group type: Experimental
description: The SWSC will include a social work assessment and follow-up augmented with additional components of supportive psychotherapy that have been shown to be an effective form of treatment for patients with cancer. Five sessions (45-60 minutes each) will be delivered over an 8-week period (+4 weeks). Following these sessions, four brief booster sessions (20-30 minutes each) will be delivered at a rate of approximately one per month to extend the interventions to 6 months (+3 months).
intervention type: Behavioral
intervention name: Cancer and Aging: Reflections for Elders (CARE) Intervention
description: For full participants (not training case participants) five sessions (45-60 minutes each) will be delivered over an 8-week period (+4 weeks). Following these sessions, four brief booster sessions (20-30 minutes each) will be delivered at a rate of approximately one per month to extend the interventions to 6 months (+3 months).
arm group label: Cancer and Aging: Reflections for Elders (CARE) Intervention
intervention type: Behavioral
intervention name: Social Work and Supportive Counseling (SWSC) Intervention
description: The SWSC will include a social work assessment and follow-up augmented with additional components of supportive psychotherapy that have been shown to be an effective form of treatment for patients with cancer. For full participants (not training case participants) five sessions (45-60 minutes each) will be delivered over an 8-week period (+4 weeks). Following these sessions, four brief booster sessions (20-30 minutes each) will be delivered at a rate of approximately one per month to extend the interventions to 6 months (+3 months). Training case participants will follow a slightly condensed schedule.
arm group label: Social Work and Supportive Counseling (SWSC)
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Christian Nelson, PhD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
last name: Christian Nelson, PhD
phone: 646-888-0030
email: nelsonc@mskcc.org
last name: Rebecca Saracino, PhD
phone: 646-888-0263
email: jamesr@mskcc.org
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
url: http://www.mskcc.org
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.