NCT05574127

Brief Summary

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)

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for phase_2

Timeline
0mo left

Started Oct 2022

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Oct 2022Jun 2026

First Submitted

Initial submission to the registry

October 6, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

October 6, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

3.7 years

First QC Date

October 6, 2022

Last Update Submit

September 30, 2025

Conditions

Survivorship

Keywords

Older Adult Cancer Survivorshistory of cancer22-248Memorial Sloan Kettering Cancer Center

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Older Adult Cancer Survivors (OACS) - Behavioral Activation (BA)

EXPERIMENTAL

Older adult cancer survivors (OACS) will receive a Behavioral Activation intervention

Behavioral: Behavioral Activation

Older Adult Cancer Survivors (OACS) - Supportive Psychotherapy (SP)

EXPERIMENTAL

Older adult cancer survivors (OACS) will receive a Supportive Psychotherapy intervention

Behavioral: Supportive Psychotherapy

Interventions

Behavioral ActivationBEHAVIORAL

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).

Also known as: BA
Older Adult Cancer Survivors (OACS) - Behavioral Activation (BA)
Supportive PsychotherapyBEHAVIORAL

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).

Also known as: SP
Older Adult Cancer Survivors (OACS) - Supportive Psychotherapy (SP)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

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 clinician confirmation:
  • a patient in MSK Survivorship Clinics AND/OR
  • no evidence of disease (NED) AND/OR
  • 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)

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. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

Location

Related Publications (1)

  • 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.

    PMID: 38342735DERIVED

Related Links

Study Officials

  • Rebecca Saracino, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2022

First Posted

October 10, 2022

Study Start

October 6, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

October 6, 2025

Record last verified: 2025-09

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.

Locations

US(1)