A Study of Counseling Support for Cancer Survivors Age 65+
A Randomized Controlled Trial of Brief Behavioral Activation for Older Adult Cancer Survivors (BBA-OACs)
1 other identifier
interventional
454
1 country
7
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2026
Longer than P75 for not_applicable
7 active sites
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
Study Start
First participant enrolled
August 10, 2026
CompletedFirst Submitted
Initial submission to the registry
August 12, 2026
CompletedFirst Posted
Study publicly available on registry
August 17, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2030
September 3, 2026
September 1, 2026
4 years
August 12, 2026
September 2, 2026
Conditions
Keywords
Outcome Measures
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.
1 year
Study Arms (2)
Behavioral Activation for Older Adult Cancer Survivor ( BBA-OAC)
EXPERIMENTALInvolves 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
Supportive Psychotherapy (SP)
ACTIVE COMPARATORFull 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
- 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)
You may not qualify if:
- 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:
- 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)
- What is your preferred language for healthcare? (must respond English or Spanish)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering at Nassau (Limited Protocol Activities)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rebbeca Saracino, PhD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2026
First Posted
August 17, 2026
Study Start
August 10, 2026
Primary Completion (Estimated)
August 1, 2030
Study Completion (Estimated)
August 1, 2030
Last Updated
September 3, 2026
Record last verified: 2026-09
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.