Managing Cancer and Living Meaningfully (CALM): randomised feasibility trial in patients with advanced cancer

Lo, Chris, Hales, Sarah, Chiu, Aubrey, Panday, Tania, Malfitano, Carmine, Jung, Judy, Rydall, Anne, Li, Madeline, Zimmermann, Camilla, and Rodin, Gary (2019) Managing Cancer and Living Meaningfully (CALM): randomised feasibility trial in patients with advanced cancer. BMJ Supportive and Palliative Care, 9 (2). pp. 209-218.

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Background: 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).

Aims: To test trial methodology and assess feasibility of a confirmatory RCT.

Design: 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.

Setting/participants: 60 adult patients with advanced cancer from the Princess Margaret Cancer Centre.

Results: 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.

Item ID: 69152
Item Type: Article (Research - C1)
ISSN: 2045-4368
Keywords: Cancer; Psychological care; Supportive care; Terminal care
Funders: University Health Network Department of Psychiatry (UHNDoP), Canadian Institutes of Health Research (CIHR), Princess Margaret Cancer Foundation Hertz Centre (PMCF), Kirchmann and Kirsh Family Funds (KKFF), Campbell Family Cancer Research Institute (CFCRI), Ontario Cancer Institute at the Princess Margaret Cancer Centre (OCI-PMCC), Ontario Ministry of Health and Long Term Care (OMOHLTC)
Projects and Grants: CIHR - #MOP 106473
Date Deposited: 31 Aug 2021 04:13
FoR Codes: 52 PSYCHOLOGY > 5203 Clinical and health psychology > 520304 Health psychology @ 100%
SEO Codes: 20 HEALTH > 2001 Clinical health > 200105 Treatment of human diseases and conditions @ 100%
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