RT Journal Article SR Electronic T1 Managing Cancer And Living Meaningfully (CALM): randomised feasibility trial in patients with advanced cancer JF BMJ Supportive & Palliative Care JO BMJ Support Palliat Care FD British Medical Journal Publishing Group SP 209 OP 218 DO 10.1136/bmjspcare-2015-000866 VO 9 IS 2 A1 Chris Lo A1 Sarah Hales A1 Aubrey Chiu A1 Tania Panday A1 Carmine Malfitano A1 Judy Jung A1 Anne Rydall A1 Madeline Li A1 Rinat Nissim A1 Camilla Zimmermann A1 Gary Rodin YR 2019 UL http://spcare.bmj.com/content/9/2/209.abstract AB 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.