How to cite TSpace itemsAlways cite the published version, so the author(s) will receive recognition through services that track citation counts, e.g. Scopus. If you need to cite the page number of the author manuscript from TSpace because you cannot access the published version, then cite the TSpace version in addition to the published version using the permanent URI (handle) found on the record page.This article was made openly accessible by U of T Faculty. Please tell us how this access benefits you. Your story matters. In an intervention-only phase 2a trial, CALM showed promising results, leading to the present 2b study, which introduces procedures for randomization and improved rigor in preparation for a phase 3 randomized 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, randomization, attrition, intervention non-compliance and usual care contamination. Primary outcome: depressive symptoms (Patient Health Questionnaire-9; PHQ-9). Secondary outcomes: major depressive disorder (MDD), generalized anxiety, death anxiety, spiritual wellbeing, attachment anxiety and avoidance, self-esteem, experiential avoidance, quality of life and posttraumatic growth. Bayesian conjugate analysis was used in this low-powered setting.Setting/participants: Sixty adult patients with advanced cancer from the Princess Margaret Cancer Centre.Results: Rate of consent was 32%, randomization 78%, attrition 25%, non-compliance 37% and contamination 17%. There was support for potential treatment effects on: PHQ-9, Odds Ratio (OR) =
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. Registration: ClinicalTrials.gov NCT02353546.