Managing cancer and living meaningfully (CALM) in adults with malignant glioma: a proof-of-concept phase IIa trial

• Published in: Journal of neuro-oncology 2022-05, Vol.157 (3), p.447-456
• Main Authors: Loughan, Ashlee R., Willis, Kelcie D., Braun, Sarah Ellen, Rodin, Gary, Lanoye, Autumn, Davies, Alexandria E., Svikis, Dace, Mazzeo, Suzanne, Malkin, Mark, Thacker, Leroy
• Format: Article
• Language: English
• Subjects: Adult; Anxiety; Anxiety - etiology; Anxiety - therapy; Cancer; Clinical Study; Clinical trials; Death; Depression - etiology; Depression - therapy; Feasibility Studies; Female; Glioblastoma; Glioma; Glioma - therapy; Humans; Male; Medicine; Medicine & Public Health; Mental depression; Middle Aged; Neoplasm Recurrence, Local; Neurology; Oncology; Psychotherapy; Psychotherapy, Brief; Quality of Life
• ISSN: 0167-594X; 1573-7373; 1573-7373
• DOI: 10.1007/s11060-022-03988-8

Background Managing Cancer and Living Meaningfully (CALM) is an evidence-based, brief, semi-structured psychotherapy designed to help patients with advanced cancer cope with the practical and profound challenges of their illness. However, no study to date has investigated its feasibility, acceptability, and preliminary effectiveness in adults with malignant glioma, despite the well-documented incidence of psychological distress in this vulnerable and underserved population. Methods Fourteen patients with glioma and elevated symptoms of depression and/or death anxiety enrolled in the trial: 83% glioblastoma, 75% female, M age  = 56 years (SD = 15.1; range = 27–81). Feasibility was assessed based on established metrics. Acceptability was measured by post-session surveys and post-intervention interviews. Preliminary intervention effects were explored using paired t-tests, comparing psychological distress at baseline and post-intervention. Results Of the 14 enrolled patients, 12 were evaluable. Nine completed the study (75% retention rate). Three patients withdrew due to substantial disease progression which affected their ability to participate. Participants reported high perceived benefit, and all recommended the program to others. Baseline to post-intervention assessments indicated reductions in death anxiety, generalized anxiety, and depression, and increases in spirituality. Quality of life and fear of cancer recurrence remained stable throughout the study period. Conclusions CALM appears feasible for use with adults with malignant glioma. Enrollment and retention rates were high and comparable to psychotherapy trials for patients with advanced cancer. High perceived benefit and reductions in symptoms of death anxiety, generalized anxiety, and depression were reported by participants. These findings are extremely encouraging and support further study of CALM in neuro-oncology. Trial Registration Number NCT04646213 registered on 11/27/2020.