title: Managing Cancer And Living Meaningfully (CALM): randomised feasibility trial in patients with advanced cancer.
abstract: 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).
  
  
  OBJECTIVE
  To test trial methodology and assess feasibility of a confirmatory RCT.
  
  
  METHODS
  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.
  
  
  METHODS
  depressive symptoms (Patient Health Questionnaire-9; PHQ-9).
  
  
  RESULTS
  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.
  
  
  METHODS
  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.
  
  
  BACKGROUND
  NCT02353546.
authors.affiliation: Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.|Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Chris
authors.initials: C
authors.lastname: Lo
authors.affiliation: Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.|Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Sarah
authors.initials: S
authors.lastname: Hales
authors.affiliation: Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.
authors.forename: Aubrey
authors.initials: A
authors.lastname: Chiu
authors.affiliation: Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.
authors.forename: Tania
authors.initials: T
authors.lastname: Panday
authors.affiliation: Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.
authors.forename: Carmine
authors.initials: C
authors.lastname: Malfitano
authors.affiliation: Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.
authors.forename: Judy
authors.initials: J
authors.lastname: Jung
authors.affiliation: Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.
authors.forename: Anne
authors.initials: A
authors.lastname: Rydall
authors.affiliation: Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.|Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Madeline
authors.initials: M
authors.lastname: Li
authors.affiliation: Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.|Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Rinat
authors.initials: R
authors.lastname: Nissim
authors.affiliation: Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.|Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.|Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Camilla
authors.initials: C
authors.lastname: Zimmermann
authors.affiliation: Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.|Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Gary
authors.initials: G
authors.lastname: Rodin
mesh_terms: D000223:Adaptation, Psychological; D000328:Adult; D000368:Aged; D001499:Bayes Theorem; D003362:Cost-Benefit Analysis / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000523:psychology*; D009864:Ontario; D010865:Pilot Projects; D011614:Psychotherapy, Brief / Q000191:economics*; D011788:Quality of Life / Q000523:psychology*; D013315:Stress, Psychological / Q000191:economics* / Q000628:therapy*
keywords: Cancer; Psychological care; Supportive care; Terminal care