Clinical trial · Interventional
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)
NCT07768449CI-TRIAL-00125710recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Survivors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| assessments (questionnaires) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Behavioral Activation for Older Adult Cancer Survivor ( BBA-OAC)
- description
- 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
- interventionNames
- Other: assessments (questionnaires)
- type
- ACTIVE_COMPARATOR
- label
- Supportive Psychotherapy (SP)
- description
- 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.
- interventionNames
- Other: assessments (questionnaires)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.