Recruiting

BBA

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07768449

Conditions

Cancer Survivors

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

assessments (questionnaires)

Study Details

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).

Conditions

Cancer Survivors

Study ID

NCT07768449

Start date

Aug 10, 2026

Status verified date

Sep, 2026

Completion date

Aug, 2030

Anticipated

Primary completion date

Aug, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

454 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Supportive Care

Interventions and Outcome Measures

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

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.

Interventions

assessments (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.

Primary outcome measure

  • change in Patient Health Questionnaire 9 (PHQ-9 at T2) [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Rebecca Saracino, PhD

646-888-0263jamesr@mskcc.org

Locations

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Rebecca Saracino, PhD

646-888-0263

Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Rebecca Saracino, PhD

646-888-0263

Memorial Sloan Kettering at Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Rebecca Saracino, PhD

646-888-0263

Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Rebecca Saracino, PhD

646-888-0263

Memorial Sloan Kettering at Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Rebecca Saracino, PhD

646-888-0263

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Rebecca Saracino, PhD

646-888-0263jamesr@mskcc.org

Devika Jutagir, PhD

646-888-8361

Memorial Sloan Kettering at Nassau (Limited Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Rebecca Saracino, PhD

646-888-0263

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • Cognitive Behavioral Therapy
  • 26-200

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-09-03.