A New Psychotherapy Intervention for Older Cancer Patients
Cancer and Aging Reflections for Elders (CARE): A Geriatric-Specific Psychotherapy for Older Adults With Cancer
1 other identifier
interventional
459
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cancer
Started Feb 2021
Longer than P75 for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2020
CompletedFirst Posted
Study publicly available on registry
June 30, 2020
CompletedStudy Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
April 17, 2026
April 1, 2026
6.3 years
June 26, 2020
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Depression and Anxiety: Hospital Anxiety and Depression Scale (HADS)
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.
9 months
Study Arms (2)
Cancer and Aging: Reflections for Elders (CARE) Intervention
EXPERIMENTALSession 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).
Social Work and Supportive Counseling (SWSC)
EXPERIMENTALThe 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).
Interventions
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).
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.
Eligibility Criteria
You may qualify if:
- As per self-report or medical record, ≥ 70 years of age
- As per self-report or medical record, has a diagnosis of cancer
- As per self-report or medical record, receiving active treatment (e.g., radiation, chemotherapy, hormone); OR received active treatment in the past 6 months (N/A for training case participants); OR are currently on active surveillance with follow-ups at least approximately every 6 months
- Received a HADS-D score of ≥ 6 or HADS-A score of ≥ 6 or a score of ≥ 4 on the distress thermometer. (N/A for training case participants)
- Received a Karnofsky Performance Rating Scale (KPRS) score of ≥ 60 (N/A for training case participants)
- Received a Blessed Orientation-Memory-Concentration Scale (BOMC) score of ≤ 11 (N/A for training case participants)
- Fluent in English, as per self-reported fluency of "well" or "very well"\*
You may not qualify if:
- As per self-report, currently taking antidepressant medication for \< 3 months
- As per self-report, currently receiving hospice care
- In the judgment of the consenting professional is unable to provide informed consent and complete study sessions and assessment
- As per self-report or as documented in the medical record, current untreated (e.g., no medication, no therapy) major psychotic disorder (schizotypal personality disorder, schizophreniform disorder, schizoaffective disorder). Patients diagnosed with a major psychiatric disorder will be reviewed by the study PI to determine eligibility prior to consent.
- Language verification: Prior to enrollment, patients will be asked the following two questions by research staff to verify English fluency necessary for participation in the study:
- How well do you speak English? (must respond "Well" or "Very well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)
- What is your preferred language for healthcare? (must respond English)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Breitbart, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2020
First Posted
June 30, 2020
Study Start
February 1, 2021
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
May 31, 2027
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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.