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

• Published in: Supportive care in cancer Vol. 24; no. 2; pp. 711 - 722
• Main Authors: Lambert, Sylvie D., McElduff, Patrick, Girgis, Afaf, Levesque, Janelle V., Regan, Tim W., Turner, Jane, Candler, Hayley, Mihalopoulos, Cathrine, Shih, Sophy T. F., Kayser, Karen, Chong, Peter
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01.02.2016; Springer; Springer Nature B.V
• Subjects: Adaptation, Psychological; Caregivers; Clinical trials; Couples; Data collection; Double-Blind Method; Family Characteristics; Humans; Male; Medicine; Medicine & Public Health; Middle Aged; Nursing; Nursing Research; Oncology; Original Article; Pain Medicine; Pilot Projects; Prostate cancer; Prostatic Neoplasms - psychology; Prostatic Neoplasms - therapy; Randomized Controlled Trials as Topic - ethics; Randomized Controlled Trials as Topic - methods; Rehabilitation Medicine; Self Care - ethics; Self Care - methods; Studies; Surveys; Surveys and Questionnaires; Pilot study; Caregivers; Partners; Coping; Self-care; Self-directed intervention
• ISSN: 0941-4355; 1433-7339
• DOI: 10.1007/s00520-015-2833-3

Purpose 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.