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01.12.2012 | Study protocol | Ausgabe 1/2012 Open Access

Health and Quality of Life Outcomes 1/2012

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

Zeitschrift:
Health and Quality of Life Outcomes > Ausgabe 1/2012
Autoren:
Sylvie D Lambert, Afaf Girgis, Jane Turner, Patrick McElduff, Karen Kayser, Paula Vallentine
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​1477-7525-10-119) contains supplementary material, which is available to authorized users.

Competing interests

The authors declare that they have no competing interests.

Authors’ contributions

SL conceived the study, participated in its design, led the development of the Coping-Together resource, and drafted the manuscript. AG, JT, PV and KK participated in the design of this study, provided critical feedback on Coping-Together, and provided feedback on the draft of this manuscript. PM participated in the design of this study and provided feedback on the draft of this manuscript. All authors have read and approved the final manuscript.

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 ACTRN12611000438​954
Zusatzmaterial
Authors’ original file for figure 1
12955_2012_991_MOESM1_ESM.pdf
Authors’ original file for figure 2
12955_2012_991_MOESM2_ESM.pdf
Literatur
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