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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)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07768449
Enrollment
454
Registered
2026-08-17
Start date
2026-08-10
Completion date
2030-08-01
Last updated
2026-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Survivors

Keywords

Cognitive Behavioral Therapy, 26-200

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).

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.

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER
National Institutes of Health (NIH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
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

* 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)

Design outcomes

Primary

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

Countries

United States

Contacts

CONTACTRebecca Saracino, PhD
jamesr@mskcc.org646-888-0263
PRINCIPAL_INVESTIGATORRebbeca Saracino, PhD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 4, 2026