title: A pilot randomized controlled trial of the feasibility of a self-directed coping skills intervention for couples facing prostate cancer: rationale and design.
abstract: BACKGROUND
  Although it is known both patients' and partners' reactions to a prostate cancer diagnosis include fear, uncertainty, anxiety and depression with patients' partners' reactions mutually determining how they cope with and adjust to the illness, few psychosocial interventions target couples. Those that are available tend to be led by highly trained professionals, limiting their accessibility and long-term sustainability. In addition, it is recognised that patients who might benefit from conventional face-to-face psychosocial interventions do not access these, either by preference or because of geographical or mobility barriers. Self-directed interventions can overcome some of these limitations and have been shown to contribute to patient well-being. This study will examine the feasibility of a self-directed, coping skills intervention for couples affected by cancer, called Coping-Together, and begin to explore its potential impact on couples' illness adjustment. The pilot version of Coping-Together includes a series of four booklets, a DVD, and a relaxation audio CD.
  
  
  METHODS
  In this double-blind, two-group, parallel, randomized controlled trial, 70 couples will be recruited within 4 months of a prostate cancer diagnosis through urology private practices and randomized to: 1) Coping-Together or 2) a minimal ethical care condition. Minimal ethical care condition couples will be mailed information booklets available at the Cancer Council New South Wales and a brochure for the Cancer Council Helpline. The primary outcome (anxiety) and additional secondary outcomes (distress, depression, dyadic adjustment, quality of life, illness or caregiving appraisal, self-efficacy, and dyadic and individual coping) will be assessed at baseline (before receiving study material) and 2 months post-baseline. Intention-to-treat and per protocol analysis will be conducted.
  
  
  CONCLUSIONS
  As partners' distress rates exceed not only population norms, but also those reported by patients themselves, it is imperative that coping skills interventions target the couple as a unit and enhance both partners' ability to overcome cancer challenges. This pilot study will examine the feasibility and potential efficacy of Coping-Together in optimising couples' illness adjustment. This is one of the first feasibility studies to test this innovative coping intervention, which in turn will contribute to the larger literature advocating for psychosocial care of couples affected by prostate cancer.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry ACTRN12611000438954.
authors.affiliation: Translational Cancer Research Unit, Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, UNSW Medicine, The University of New South Wales, Liverpool, BC NSW, 2170, Australia.
authors.forename: Sylvie D
authors.initials: SD
authors.lastname: Lambert
authors.forename: Afaf
authors.initials: A
authors.lastname: Girgis
authors.forename: Jane
authors.initials: J
authors.lastname: Turner
authors.forename: Patrick
authors.initials: P
authors.lastname: McElduff
authors.forename: Karen
authors.initials: K
authors.lastname: Kayser
authors.forename: Paula
authors.initials: P
authors.lastname: Vallentine
mesh_terms: D000223:Adaptation, Psychological; D004311:Double-Blind Method; D005240:Feasibility Studies; D005260:Female; D006266:Health Education; D015277:Hotlines; D006801:Humans; D008297:Male; D009517:New South Wales; D017063:Outcome Assessment, Health Care / Q000379:methods; D010174:Pamphlets; D010865:Pilot Projects; D011340:Problem Solving; D011471:Prostatic Neoplasms / Q000175:diagnosis / Q000523:psychology*; D011594:Psychometrics; D012107:Research Design; D012648:Self Care / Q000379:methods*; D012944:Social Support; D018454:Spouses / Q000193:education / Q000523:psychology*; D013315:Stress, Psychological / Q000175:diagnosis / Q000517:prevention & control; D016896:Treatment Outcome