Managing Cancer and Living Meaningfully in adults with brain metastases: A NIH ORBIT model phase II feasibility and proof-of-concept trial.

Résumé

BACKGROUND: Managing Cancer and Living Meaningfully (CALM) is a brief, evidence-based psychotherapy designed to help patients with advanced cancer cope with the practical and profound challenges of their illness. However, no study has systematically examined CALM in adults with brain metastases, despite the well-documented incidence of distress in this growing population. The primary aim of this trial was to assess the feasibility and acceptability of CALM in adults with brain metastases.METHODS: Patients with brain metastases ( = 13) and elevated symptoms of depression and/or death anxiety enrolled in this single-arm trial. CALM was administered in 6 biweekly sessions, with outcomes assessed at baseline and post-intervention. Feasibility was assessed based on established metrics including enrollment and retention rates. Acceptability was measured by post-session surveys and post-intervention interviews. Preliminary signal change on measures of psychological distress was explored.RESULTS: Of the 13 enrolled participants, 11 completed baseline assessments and initiated treatment: 73% female,  = 58 years (SD = 12.9; range = 37-75). Nine completed the study (81% retention rate). Overall, participants reported high perceived benefits and would recommend the program to others. Baseline to post-intervention assessments indicated improvements in depression, death anxiety, generalized anxiety, post-traumatic stress, suicidal ideation, and spiritual well-being. Life quality, substance use, and fear of cancer recurrence remained relatively stable.CONCLUSIONS: CALM is feasible and acceptable and may improve psychological distress in adults with brain metastases. The findings of this study align with our previous trial of patients with malignant glioma and support a future National Institute of Health Obesity Related Behavioral Intervention Trials phase II randomized pilot trial of CALM in neuro-oncology.TRIAL REGISTRATION NUMBER: NCT05087095 registered on March 23, 2022.