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
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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.
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.
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.
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.
KeywordsCoping Pilot study Self-care Self-directed intervention Caregivers Partners
This study was funded by a Clinical Oncological Society of Australia/Sanofi Aventis Advancing the Care for Prostate Care Patients Research Grant 2010.
Conflict of interest
The authors declare that they have no competing interests.
- 5.Northouse LL, Katapodi MC, Song L, Zhang L, Mood DW (2010) Interventions with family caregivers of cancer patients: meta-analysis of randomized trials. Cancer J Clin 60:317–339Google Scholar
- 11.Lambert SD, Girgis A, Turner J, Regan T, Candler H, Britton B et al (2013) “"You need something like this to give you guidelines on what to do”: patients’ and partners’ use and perceptions of a self-directed, coping skills training resource. Support Care Cancer 21:3451–3460PubMedCrossRefGoogle Scholar
- 12.Lambert SD, Girgis A, Turner J, McElduff P, Kayser K, Vallentine P (2012) A pilot randomized controlled trial of the feasibility of a self-directed coping skills intervention for couples facing prostate cancer: rationale and design. Health Qual Life Outcomes 10:119PubMedPubMedCentralCrossRefGoogle Scholar
- 14.National Comprehensive Cancer Network (2012) Distress management clinical practice guidelines. National Comprehensive Cancer NetworkGoogle Scholar
- 16.Zigmond AS, Snaith RP (1983) The Hospital Anxiety and Depression Scale. Acta Psychiat Scand 67:361–370Google Scholar
- 18.Weiss DS, Marmar CR (1997) The Impact of Event Scale-Revised. In: Wilson JP, Keane TM (eds) Assessing psychological trauma and PTSD. Guilford, New York, pp 399–411Google Scholar
- 20.Richardson J, Khan M, Iezzi A, Sinha K, Mihalopoulos C, Herrman H, et al. (2009) The AQoL-8D (PsyQoL) MAU Instrument: overview September 2009 Research paper39, Centre for Health EconomicsGoogle Scholar
- 22.Busby DM, Christensen C, Crane DR, Larson JH (1995) A revision of the Dyadic Adjustment Scale for use with distressed and nondistressed couples: construct hierarchy and multidimensional scales. J Marital Fam Ther 21:289–308Google Scholar
- 24.Kessler TA (1998) The Cognitive Appraisal of Health Scale: development of psychometric evaluation. Res Nurs Health 21:73–82Google Scholar
- 26.Lambert SD, Yoon H, Ellis K, Northouse L (2015) Measuring appraisal during advanced cancer: psychometric testing of the Appraisal of Caregiving Scale. Patient Educ CounsGoogle Scholar
- 28.Lewis FM (1996) Family home visitation study final report. National Cancer Institute, National Institutes of Health., BethesdaGoogle Scholar
- 29.Wolf MS, Chang CH, Davis T, Makoul G (2005) Development and validation of the Communication and Attitudinal Self-Efficacy Scale for Cancer (CASE-cancer). Patient Educ Couns 57:333–341Google Scholar
- 33.Bodenmann G (2008) Dyadisches Coping Inventar: Testmanual [Dyadic Coping Inventory: Test Manual]. Huber, BernGoogle Scholar
- 34.Girgis A, Shih STF, Lambert SD, Mihalopoulos C (2011) My Cancer Care Cost Diary. University of New South Wales & Deakin UniversityGoogle Scholar
- 36.Hacking B, Wallace L, Scott S, Kosmala-Anderson J, Belkora J, McNeill A (2013) Testing the feasibility, acceptability and effectiveness of a ‘decision navigation’ intervention for early stage prostate cancer patients in Scotland—a randomised controlled trial. Psychooncology 22:1017–1024PubMedCrossRefGoogle Scholar
- 41.Lambert SD, Kelly B, Boyes A, Cameron A, Adams C, Proietto A et al (2014) Insights into preferences for psycho-oncology services among women with gynaecologic cancer following distress screening. J Natl Compr Cancer Netw 12:899–906Google Scholar
- 43.Porter SR (2004) Raising response rates: what works? New Dir Inst Res 2004:5–21Google Scholar
- 47.Lavrakas PJ (2011) Encyclopedia of survey research methods. SAGE Publications, Thousand OaksGoogle Scholar