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

BMJ Supportive & Palliative Care
Chris LoGary Rodin

Abstract

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). 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. depressive symptoms (Patient Health Questionnaire-9; PHQ-9). 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 (...Continue Reading

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Citations

Feb 10, 2016·Palliative Medicine·Eryn TongChris Lo
Feb 21, 2018·BMC Palliative Care·Kerstin KremeikeRaymond Voltz
May 16, 2017·Palliative & Supportive Care·Katharina ScheffoldAnja Mehnert
Aug 5, 2017·BMJ Supportive & Palliative Care·Ekaterina AnGary Rodin
Dec 19, 2019·Journal of Clinical Psychology in Medical Settings·Ashlee R LoughanSarah Braun
May 11, 2017·Current Psychiatry Reports·Rosangela CarusoLuigi Grassi
Apr 20, 2019·Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer·Gary RodinCamilla Zimmermann
May 12, 2019·Psycho-oncology·Irene TeoGeok Ling Lee
Nov 25, 2020·Clinical Trials : Journal of the Society for Clinical Trials·Richard A Parker
Dec 12, 2020·Cancers·Danielle B TometichLaura Oswald
Jun 10, 2018·Journal of Pain and Symptom Management·Sujin Ann-YiCindy L Carmack

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