A Study of Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors

Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors

The purpose of this study is to find out if a psychotherapy method called behavioral activation (BA) can be successfully delivered by telephone or videoconference (remotely) and can effectively treat depression in Older Adult Cancer Survivors (OACS)

Study Overview

• Status: Active, not recruiting
• Conditions: Survivorship
• Intervention / Treatment: Behavioral: Behavioral Activation; Behavioral: Supportive Psychotherapy

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Study Population

Potential participants will be identified by the MSK study investigators, the patient's treating clinician, or review of the MSK Survivorship clinic lists. Since we plan to recruit all patients 65years of age or older, regardless of type of cancer, we will also identify potential patients by query of MSK institutional databases (e.g., DaVinci, Dataline). Once the list is created, members of the protocol research team will verify the medical eligibility against the patient's medical record prior to contacting the patient regarding participation.

Description

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 clinician confirmation:

  • a patient in MSK Survivorship Clinics AND/OR
  • no evidence of disease (NED) AND/OR
  • 6 months or more post-treatment (patients on maintenance hormonal therapies are eligible)
• Fluent in English, 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: ≥5 (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. They will be excluded from participation in this study if the PI determines they would be appropriate for a higher level of care than BA may be able to provide.
• 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 medical record, patient has impaired decision-making capacity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Older Adult Cancer Survivors (OACS) - Behavioral Activation (BA); Older adult cancer survivors (OACS) will receive a Behavioral Activation intervention	Behavioral: Behavioral Activation; Sessions for both arms (BP & SP) will be administered remotely via video-conference and/or telephone (per patient preference) at the following timeline: Full participants (not training cases): Ten sessions (30-50 minutes each) will be delivered approximately weekly over a 10-week period (+10 weeks).; Training case participants: Ten sessions (30-50 minutes each) will be delivered over an approximately 5-week period (+10 weeks).; Other Names: BA
Experimental: Older Adult Cancer Survivors (OACS) - Supportive Psychotherapy (SP); Older adult cancer survivors (OACS) will receive a Supportive Psychotherapy intervention	Behavioral: Supportive Psychotherapy; Sessions for both arms (BP & SP) will be administered remotely via video-conference and/or telephone (per patient preference) at the following timeline: Full participants (not training cases): Ten sessions (30-50 minutes each) will be delivered approximately weekly over a 10-week period (+10 weeks).; Training case participants: Ten sessions (30-50 minutes each) will be delivered over an approximately 5-week period (+10 weeks).; Other Names: SP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference of Patient Health Questionnaire 9 (PHQ-9) scores between study groups	Patient Health Questionnaire 9 (PHQ-9): The PHQ-9 consists of nine items, each of which corresponds to one of the nine symptoms required for a diagnosis of a major depressive disorder (MDD) as defined by the Diagnostic and Statistical Manual of Mental Disorders. 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). Its reliability and validity have been established in diverse general and medical populations. 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 .	2 months post intervention

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Rebecca Saracino, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

General Publications

• Saracino RM, Park EY, Demirjian C, Jutagir DR, McConnell KM, Schofield E, Raue PJ, Lejuez CW, Nelson CJ. Protocol for a randomized controlled trial of brief behavioral activation among older adult cancer survivors. J Geriatr Oncol. 2024 Jun;15(5):101719. doi: 10.1016/j.jgo.2024.101719. Epub 2024 Feb 10.

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: October 6, 2022
• First Submitted That Met QC Criteria: October 6, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Memorial Sloan Kettering Cancer Center; Older Adult Cancer Survivors; history of cancer; 22-248
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 22-248

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No