Managing Cancer And Living Meaningfully (CALM) randomised feasibility trial in patients with advanced cancer
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. Trial registration number NCT02353546.
BMJ Supportive Palliative Care