Protocol for a randomized controlled trial of brief behavioral activation among older adult cancer survivors

As many as 35% of older adult cancer survivors (OACS; i.e., ≥65 years old) have clinically significant depression. OACS often experience fatigue, mild cognitive impairment, and increased medical comorbidities post-cancer that make them susceptible to depression. Behavioral activation (BA) is an empirically supported depression treatment in geriatric psychiatry that guides individuals to reengage in pleasurable and rewarding activities and has great potential for addressing the needs of OACS. This manuscript presents the protocol for a pilot randomized controlled trial (RCT) testing the efficacy of a brief BA intervention adapted to address the needs of OACS (BBA-OACS) by telephone and videoconference delivery.

An RCT will be conducted at Memorial Sloan Kettering Cancer Center (MSK) in New York City. Participants will be randomized to either BA as a target intervention or supportive psychotherapy (SP) as a standard of care control intervention for outpatient oncology. The target intervention includes 10 weekly sessions of BA consisting of psychoeducation about depression and the rationale for BA, life areas and values assessment, compilation of a list of enjoyable and important activities across values, activity scheduling, and self-monitoring of satisfaction and mood. The standard of care control intervention includes 10 weekly sessions of SP consisting of reassurance, guidance, encouragement, and support for patients with cancer. OACS who have a history of cancer, report elevated depressive symptoms, are fluent in English, and can communicate via telephone or videoconference will be recruited from the MSK Survivorship Clinics across all disease types. Seventy participants will be recruited for the study (10 training cases, 30 in each RCT arm). The primary aim is to evaluate implementation outcomes (i.e., acceptability, feasibility, and fidelity) of BA, relative to SP, for cancer survivorship. The secondary aim is to determine the preliminary effects of BA on depressive symptoms (primary outcome), anxiety, coping, and increased activity level (secondary outcomes) compared to SP. Participants will be asked to complete a set of three surveys pre- and post-intervention.

If successful, BBA-OACS would provide frontline clinicians with an accessible, evidence-based treatment for OACS. Future research will evaluate the efficacy of BA in a larger trial and its impact on depression and other healthcare outcomes.

This study is registered under ClinicalTrials.gov (ID NCT05574127).