Managing Cancer And Living Meaningfully (CALM): Randomized feasibility trial in patients with advanced cancer.

Author(s): Lo C, Hales S, Chiu A, Panday T, Malfitano C, Jung J, Rydall A, Li M, Nissim R, Zimmermann C, Rodin G.

Managing Cancer And Living Meaningfully (CALM) is a brief individual psychotherapy for patients with advanced cancer. In an intervention-only phase 2a trial, CALM showed promising results, leading to the present 2b pilot, which introduces procedures for randomisation and improved rigour in preparation for a phase 3 randomised controlled trial (RCT). The aim is to test trial methodology and assess feasibility of a confirmatory RCT. A parallel-arm RCT (intervention vs usual care) with 3 and 6-month follow-ups. Assessment of feasibility included rates of consent, randomisation, attrition, intervention non-compliance and usual care contamination. Primary outcome: depressive symptoms (Patient Health Questionnaire-9; PHQ-9). Secondary outcomes: major depressive disorder (MDD), generalised anxiety, death anxiety, spiritual well-being, attachment anxiety and avoidance, self-esteem, experiential avoidance, quality of life and post-traumatic growth. Bayesian conjugate analysis was used in this low-powered setting. 60 adult patients with advanced cancer from the Princess Margaret Cancer Centre. Rate of consent was 32%, randomisation 78%, attrition 25%, non-compliance 37% and contamination 17%. There was support for potential treatment effects on: PHQ-9, OR=1.48, 95% Credible Interval (CRI.95) (0.65, 3.38); MDD, OR=1.56, CRI.95 (0.50, 4.84); attachment anxiety, OR=1.72, CRI.95 (0.73, 4.03); and attachment avoidance, OR=1.58, CRI.95 (0.67, 3.71). There was no support for effects on the seven remaining secondary outcomes. Conclusions A phase 3 CALM RCT is feasible and should aim to detect effect sizes of d=0.40, with greater attention to issues of compliance and contamination.

Citation: http://spcare.bmj.com/content/early/2016/01/19/bmjspcare-2015-000866.short?rss=1

Related Info

Gary Rodin

Director of GIPPEC at the Princess Margaret Cancer Centre and Professor of Psychiatry at the University of Toronto

Camilla Zimmermann

Department Head of Supportive Care at Princess Margaret Cancer Centre
Head of Division of Palliative Care at University Health Network
Professor of Medicine at the University of Toronto

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