title: A pilot, multisite, randomized controlled trial of a self-directed coping skills training intervention for couples facing prostate cancer: accrual, retention, and data collection issues.
abstract: OBJECTIVE
  To examine the acceptability of the methods used to evaluate Coping-Together, one of the first self-directed coping skill intervention for couples facing cancer, and to collect preliminary efficacy data.
  
  
  METHODS
  Forty-two couples, randomized to a minimal ethical care (MEC) condition or to Coping-Together, completed a survey at baseline and 2 months after, a cost diary, and a process evaluation phone interview.
  
  
  RESULTS
  One hundred seventy patients were referred to the study. However, 57 couples did not meet all eligibility criteria, and 51 refused study participation. On average, two to three couples were randomized per month, and on average it took 26 days to enrol a couple in the study. Two couples withdrew from MEC, none from Coping-Together. Only 44 % of the cost diaries were completed, and 55 % of patients and 60 % of partners found the surveys too long, and this despite the follow-up survey being five pages shorter than the baseline one. Trends in favor of Coping-Together were noted for both patients and their partners.
  
  
  CONCLUSIONS
  This study identified the challenges of conducting dyadic research, and a number of suggestions were put forward for future studies, including to question whether distress screening was necessary and what kind of control group might be more appropriate in future studies.
authors.affiliation: Ingram School of Nursing, McGill University, Wilson Hall, 3506 University Street, Montreal, QC, H3A 2A7, Canada. Sylvie.lambert@mcgill.ca.|Psycho-Oncology Research Group, Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, UNSW Medicine, The University of New South Wales, Locked Bag 7103, Liverpool, NSW, 1871, Australia. Sylvie.lambert@mcgill.ca.
authors.forename: Sylvie D
authors.initials: SD
authors.lastname: Lambert
authors.affiliation: School of Medicine and Public Health, The University of Newcastle, HMRI Building, John Hunter Hospital Campus, New Lambton Heights, NSW, 2305, Australia.
authors.forename: Patrick
authors.initials: P
authors.lastname: McElduff
authors.affiliation: Psycho-Oncology Research Group, Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, UNSW Medicine, The University of New South Wales, Locked Bag 7103, Liverpool, NSW, 1871, Australia.
authors.forename: Afaf
authors.initials: A
authors.lastname: Girgis
authors.affiliation: Psycho-Oncology Research Group, Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, UNSW Medicine, The University of New South Wales, Locked Bag 7103, Liverpool, NSW, 1871, Australia.
authors.forename: Janelle V
authors.initials: JV
authors.lastname: Levesque
authors.affiliation: Priority Research Centre for Health Behaviour, The University of Newcastle, University Drive, Callaghan, New South Wales, 2308, Australia.
authors.forename: Tim W
authors.initials: TW
authors.lastname: Regan
authors.affiliation: The University of Queensland, Mental Health Centre K Floor, Herston, QLD, 4029, Australia.
authors.forename: Jane
authors.initials: J
authors.lastname: Turner
authors.affiliation: Psycho-Oncology Research Group, Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, UNSW Medicine, The University of New South Wales, Locked Bag 7103, Liverpool, NSW, 1871, Australia.
authors.forename: Hayley
authors.initials: H
authors.lastname: Candler
authors.affiliation: Deakin Health Economics, Faculty of Health, Deakin University, 221 Burwood Hwy, Burwood, VIC, 3125, Australia.
authors.forename: Cathrine
authors.initials: C
authors.lastname: Mihalopoulos
authors.affiliation: Deakin Health Economics, Faculty of Health, Deakin University, 221 Burwood Hwy, Burwood, VIC, 3125, Australia.
authors.forename: Sophy T F
authors.initials: STF
authors.lastname: Shih
authors.affiliation: Kent School of Social Work, University of Louisville, Louisville, KY, 40292, USA.
authors.forename: Karen
authors.initials: K
authors.lastname: Kayser
authors.affiliation: Lake Macquarie Urology, Level 3, Suite 2 20 Smart Street, Charlestown, NSW, 2290, Australia.
authors.forename: Peter
authors.initials: P
authors.lastname: Chong
mesh_terms: D000223:Adaptation, Psychological; D004311:Double-Blind Method; D005191:Family Characteristics; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011471:Prostatic Neoplasms / Q000523:psychology / Q000628:therapy*; D016032:Randomized Controlled Trials as Topic / Q000941:ethics* / Q000379:methods*; D012648:Self Care / Q000941:ethics / Q000379:methods; D011795:Surveys and Questionnaires
keywords: Caregivers; Coping; Partners; Pilot study; Self-care; Self-directed intervention