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RecruitingNCT07768449Updated Sep 3, 2026

A Study of Counseling Support for Cancer Survivors Age 65+

An interventional study of assessments (questionnaires) in Cancer Survivors, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 7 sites in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.

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

Phase
Not applicable
Study type
Interventional
Enrollment
454
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

The purpose of this study is to find out if a psychotherapy method called brief behavioral activation (BBA) can improve depression, anxiety, and overall well-being and encourage healthy lifestyle behaviors in English- and Spanish-speaking Older Adult Cancer Survivors (OACS). BBA is a therapeutic technique that guides people to set goals and engage in enjoyable or rewarding activities as a way of changing behavior and reducing symptoms of depression. In this study, BBA will be given by telephone or videoconference (remotely).

02

Conditions studied

  • Cancer Survivors

Keywords

  • Cognitive Behavioral Therapy
  • 26-200
03

Who can participate

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

Inclusion criteria

  • As per self-report or medical record, ≥65 years old
  • As per self-report or medical record, has a history of cancer
  • As per medical record and/or self-report:

    • currently with no evidence of disease (NED) AND/OR
    • 6 months or more post-treatment
  • Fluent in English or Spanish, as per self-reported fluency of "well" or "very well"*
  • As per self-report, able to communicate over video-conference and/or phone for sessions
  • Elevated score on the PHQ-9: ≥8 (N/A for Training Case participants)
  • Received a Blessed Orientation-Memory-Concentration Scale (BOMC) score of ≤ 11 (N/A for Training Case participants)

Exclusion criteria

Exclusion Criteria:

  • As per PI determination, requires a higher level of care for current passive or active suicidal ideation than current protocol is able to provide. If a participant receives a score of > 0 on item 9 of the PHQ-9, they will be referred to study PI for further evaluation using the Columbia-Suicide Severity Rating Scale (CSSR) (MSK Standard) to determine level of risk;. Only those with active suicidal ideation will be excluded and referred to a higher level of care.
  • 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.
  • As per self-report or medical record, currently taking antidepressant medication for \< 3 month
  • As per self-report, engagement in regular individual psychotherapeutic support that the participant is unable or unwilling to put on hold for the course of the study
  • [MSK patients only] As per medical record, patient has impaired decision-making capacity
  • Language verification: Prior to enrollment, patients will be asked the following two questions by research staff to verify English or Spanish fluency necessary for participation in the study:

    1. How well do you speak English/ Spanish? (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 or Spanish)
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Outcomes assessor)
Enrollment
454 participants (estimated)

Study arms

  • Experimental
    Behavioral Activation for Older Adult Cancer Survivor ( BBA-OAC)

    Involves 10 30-50-minute telephone and/or video-conference sessions with structured agendas for interventionists consisting of: 1. Psychoeducation about depression and the rationale for BBA-OACs, and invitation to share one's cancer story and ongoing medical and psychosocial concerns 2. Compilation of a list of pleasant and rewarding social, physical, and recreational activities in line with participants' values 3. Daily activity scheduling; and 4. Self-monitoring of satisfaction and mood

    Other: assessments (questionnaires)

  • Active comparator
    Supportive Psychotherapy (SP)

    Full SP participants (not training case participants) will also complete 10 sessions, 30-50 minutes each, over the telephone or video-conference with SP-trained interventionists.

    Other: assessments (questionnaires)

Interventions

  • Otherassessments (questionnaires)

    Complete assessments (questionnaires) before the intervention begins (at baseline), after the last session (around Week 10) and a follow-up assessment at Week 18 (or approximately 2 months after the sessions end.

05

What researchers measure

Primary outcomes

  1. change in Patient Health Questionnaire 9 (PHQ-9 at T2)

    Respondents are asked to rate how often they have been bothered by each of the nine symptoms over the preceding two weeks. Respondents rate each item on a four-point scale (0=not at all, 1=several days, 2=more than half the days, 3=nearly every day). Total scores range from 0-27; In outpatient cancer settings, psychometric research suggests that a score of ≥8 indicates clinically significant depressive symptoms and should be used as a clinical cut-off.

    Time frame: 1 year

06

Study locations

7 of 7 sites recruiting
  • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
    Basking Ridge, New Jersey 07920, United States
    • Rebecca Saracino, PhD · Contact · 646-888-0263
    Recruiting
  • Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
    Middletown, New Jersey 07748, United States
    • Rebecca Saracino, PhD · Contact · 646-888-0263
    Recruiting
  • Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
    Montvale, New Jersey 07645, United States
    • Rebecca Saracino, PhD · Contact · 646-888-0263
    Recruiting
  • Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
    Commack, New York 11725, United States
    • Rebecca Saracino, PhD · Contact · 646-888-0263
    Recruiting
  • Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
    Harrison, New York 10604, United States
    • Rebecca Saracino, PhD · Contact · 646-888-0263
    Recruiting
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
    • Rebecca Saracino, PhD · Contact · jamesr@mskcc.org · 646-888-0263
    • Devika Jutagir, PhD · Contact · 646-888-8361
    Recruiting
  • Memorial Sloan Kettering at Nassau (Limited Protocol Activities)
    Uniondale, New York 11553, United States
    • Rebecca Saracino, PhD · Contact · 646-888-0263
    Recruiting
07

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.

08

Registry details

Key details

Study ID
NCT07768449
Lead sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Institutes of Health (NIH)
Responsible party
Sponsor
First posted
Aug 17, 2026
Start date
Aug 10, 2026
Primary completion
Aug 2030 (estimated)
Completion
Aug 2030 (estimated)
Last update
Sep 3, 2026

Study contacts

Rebecca Saracino, PhD
Contact
jamesr@mskcc.org
646-888-0263
Rebbeca Saracino, PhD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

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

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