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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
RCT Entities:
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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
Entities:
Keywords:
Cancer; Psychological care; Supportive care; Terminal care
Authors: Ashlee R Loughan; Kelcie D Willis; Sarah Ellen Braun; Gary Rodin; Autumn Lanoye; Alexandria E Davies; Dace Svikis; Suzanne Mazzeo; Mark Malkin; Leroy Thacker Journal: J Neurooncol Date: 2022-04-18 Impact factor: 4.506
Authors: Danielle B Tometich; Kelly A Hyland; Hatem Soliman; Heather S L Jim; Laura Oswald Journal: Cancers (Basel) Date: 2020-12-08 Impact factor: 6.639