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RecruitingNCT04452825Updated Apr 17, 2026

A New Psychotherapy Intervention for Older Cancer Patients

An interventional study of Cancer and Aging: Reflections for Elders (CARE) Intervention and Social Work and Supportive Counseling (SWSC) Intervention in Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 1 site in United States. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2026-04-17.

Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Feb 2021; still recruiting 5 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
459
Allocation
Randomized
Ages
70 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cancer

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Keywords

  • geriatric cancer
  • geriatric specific
  • older adults with cancer
  • Psychotherapy
  • Memorial Sloan Kettering Cancer Center
  • 20-191
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 459 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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"*

Exclusion criteria

Exclusion Criteria:

  • 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:

      1. 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)
      2. What is your preferred language for healthcare? (must respond English)
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
459 participants (estimated)

Study arms

  • Experimental
    Cancer and Aging: Reflections for Elders (CARE) Intervention

    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).

    Behavioral: Cancer and Aging: Reflections for Elders (CARE) Intervention

  • Experimental
    Social Work and Supportive Counseling (SWSC)

    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).

    Behavioral: Social Work and Supportive Counseling (SWSC) Intervention

Interventions

  • BehavioralCancer and Aging: Reflections for Elders (CARE) Intervention

    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).

  • BehavioralSocial Work and Supportive Counseling (SWSC) Intervention

    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.

06

What researchers measure

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.

    Time frame: 9 months

07

Study locations

1 of 1 sites recruiting
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
    • William Breitbart, MD · Contact · 646-888-0030
    • Rebecca Saracino, PhD · Contact · 646-888-0263
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04452825
Lead sponsor
Memorial Sloan Kettering Cancer Center
Responsible party
Sponsor
First posted
Jun 30, 2020
Start date
Feb 1, 2021
Primary completion
May 31, 2027 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Apr 17, 2026

Study contacts

William Breitbart, MD
Contact
breitbaw@mskcc.org
646-888-0020
Rebecca Saracino, PhD
Contact
jamesr@mskcc.org
646-888-0263
William Breitbart, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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