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Open Access Study protocol

A pilot randomized controlled trial of the feasibility of a self-directed coping skills intervention for couples facing prostate cancer: Rationale and design

Sylvie D Lambert1*, Afaf Girgis1, Jane Turner2, Patrick McElduff3, Karen Kayser4 and Paula Vallentine5

Author Affiliations

1 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

2 The University of Queensland, Mental Health Centre K Floor, Herston, QLD 4029, Australia

3 School of Medicine and Public Health, The University of Newcastle, Hunter Medical Research Institute (HMRI) Building, New Lambton, NSW 2305, Australia

4 Kent School of Social Work, University of Louisville, Louisville, KY 40292, USA

5 Cancer Council NSW, 153 Dowling Street, Woolloomooloo, NSW 2011, Australia

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Health and Quality of Life Outcomes 2012, 10:119  doi:10.1186/1477-7525-10-119

Published: 26 September 2012

Abstract

Background

Although it is known both patients’ and partners’ reactions to a prostate cancer diagnosis include fear, uncertainty, anxiety and depression, with patients’ and 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/design

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.

Discussion

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.

Trial registration

Australian New Zealand Clinical Trials Registry ACTRN12611000438954

Keywords:
Psychosocial adjustment; Couple; Family; Prostate cancer; Stress-coping; Dyadic coping; Anxiety; Intervention; Self-directed; Information resources