title: Living with prostate cancer: randomised controlled trial of a multimodal supportive care intervention for men with prostate cancer.
abstract: BACKGROUND
  Prostate cancer is the most common male cancer in developed countries and diagnosis and treatment carries with it substantial morbidity and related unmet supportive care needs. These difficulties may be amplified by physical inactivity and obesity. We propose to apply a multimodal intervention approach that targets both unmet supportive care needs and physical activity.
  
  
  METHODS
  A two arm randomised controlled trial will compare usual care to a multimodal supportive care intervention "Living with Prostate Cancer" that will combine self-management with tele-based group peer support. A series of previously validated and reliable self-report measures will be administered to men at four time points: baseline/recruitment (when men are approximately 3-6 months post-diagnosis) and at 3, 6, and 12 months after recruitment and intervention commencement. Social constraints, social support, self-efficacy, group cohesion and therapeutic alliance will be included as potential moderators/mediators of intervention effect. Primary outcomes are unmet supportive care needs and physical activity levels. Secondary outcomes are domain-specific and health-related quality of life (QoL); psychological distress; benefit finding; body mass index and waist circumference. Disease variables (e.g. cancer grade, stage) will be assessed through medical and cancer registry records. An economic evaluation will be conducted alongside the randomised trial.
  
  
  CONCLUSIONS
  This study will address a critical but as yet unanswered research question: to identify a population-based way to reduce unmet supportive care needs; promote regular physical activity; and improve disease-specific and health-related QoL for prostate cancer survivors. The study will also determine the cost-effectiveness of the intervention.
  
  
  BACKGROUND
  ACTRN12611000392965.
authors.affiliation: Griffith Health Institute, Griffith University, Gold Coast, Australia. suzanne.chambers@griffith.edu.au.
authors.forename: Suzanne K
authors.initials: SK
authors.lastname: Chambers
authors.forename: Robert U
authors.initials: RU
authors.lastname: Newton
authors.forename: Afaf
authors.initials: A
authors.lastname: Girgis
authors.forename: Lisa
authors.initials: L
authors.lastname: Nielsen
authors.forename: Stephen
authors.initials: S
authors.lastname: Lepore
authors.forename: Cathrine
authors.initials: C
authors.lastname: Mihalopoulos
authors.forename: Ra
authors.initials: R
authors.lastname: Gardiner
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Galvão
authors.forename: Stefano
authors.initials: S
authors.lastname: Occhipinti
mesh_terms: D000223:Adaptation, Psychological / Q000502:physiology; D003131:Combined Modality Therapy; D015444:Exercise / Q000502:physiology*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D011471:Prostatic Neoplasms / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D011788:Quality of Life / Q000523:psychology; D012648:Self Care; D012944:Social Support; D011795:Surveys and Questionnaires; D016896:Treatment Outcome