title: Beating the blues after cancer: randomised controlled trial of a tele-based psychological intervention for high distress patients and carers.
abstract: BACKGROUND
  The diagnosis and treatment of cancer is a major life stress such that approximately 35% of patients experience persistent clinically significant distress and carers often experience even higher distress than patients. This paper presents the design of a two arm randomised controlled trial with patients and carers who have elevated psychological distress comparing minimal contact self management vs. an individualised tele-based cognitive behavioural intervention.
  
  
  METHODS
  140 patients and 140 carers per condition (560 participants in total) will been recruited after being identified as high distress through caller screening at two community-based cancer helplines and randomised to 1) a single 30-minute telephone support and education session with a nurse counsellor with self management materials 2) a tele-based psychologist delivered five session individualised cognitive behavioural intervention. Session components will include stress reduction, problem-solving, cognitive challenging and enhancing relationship support and will be delivered weekly. Participants will be assessed at baseline and 3, 6 and 12 months after recruitment. Outcome measures include: anxiety and depression, cancer specific distress, unmet psychological supportive care needs, positive adjustment, overall Quality of life.
  
  
  CONCLUSIONS
  The study will provide recommendations about the efficacy and potential economic value of minimal contact self management vs. tele-based psychologist delivered cognitive behavioural intervention to facilitate better psychosocial adjustment and mental health for people with cancer and their carers.
  
  
  BACKGROUND
  ACTRN12609000301268.
authors.affiliation: Griffith Institute for Health and Medical Research, Griffith University, Brisbane, Australia. suzannechambers@cancerqld.org.au
authors.forename: Suzanne K
authors.initials: SK
authors.lastname: Chambers
authors.forename: Afaf
authors.initials: A
authors.lastname: Girgis
authors.forename: Stefano
authors.initials: S
authors.lastname: Occhipinti
authors.forename: Sandy
authors.initials: S
authors.lastname: Hutchison
authors.forename: Jane
authors.initials: J
authors.lastname: Turner
authors.forename: Rob
authors.initials: R
authors.lastname: Carter
authors.forename: Jeff
authors.initials: J
authors.lastname: Dunn
mesh_terms: D000223:Adaptation, Psychological; D001007:Anxiety / Q000150:complications; D017028:Caregivers; D016022:Case-Control Studies; D003863:Depression / Q000150:complications / Q000209:etiology*; D005260:Female; D017048:Health Care Costs; D006801:Humans; D008297:Male; D009369:Neoplasms / Q000150:complications* / Q000523:psychology*; D010353:Patient Education as Topic / Q000191:economics / Q000379:methods; D011584:Psychology / Q000379:methods; D011613:Psychotherapy / Q000379:methods; D011788:Quality of Life; D017216:Telemedicine / Q000191:economics / Q000379:methods*