NCT05574127 A Study of Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors
| NCT ID | NCT05574127 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Survivorship |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2022-10-06 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2022-10-06 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Eligibility Criteria
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
Contact & Investigator
Rebecca Saracino, PhD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT05574127 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Survivorship. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05574127 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05574127 currently recruiting?
Yes, NCT05574127 is actively recruiting participants. Contact the research team at jamesr@mskcc.org for enrollment information.
Where is the NCT05574127 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05574127 clinical trial?
NCT05574127 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Rebecca Saracino, PhD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 90 participants.