A parallel-group, randomised controlled trial of a multimedia, self-directed, coping skills training intervention for patients with cancer and their partners: design and rationale.

Abstract:

INTRODUCTION:Coping skills training interventions have been found to be efficacious in helping both patients and their partners manage the physical and emotional challenges they face following a cancer diagnosis. However, many of these interventions are costly and not sustainable. To overcome these issues, a self-directed format is increasingly used. The efficacy of self-directed interventions for patients has been supported; however, no study has reported on the outcomes for their partners. This study will test the efficacy of Coping-Together-a multimedia, self-directed, coping skills training intervention for patients with cancer and their partners. METHODS AND ANALYSIS:The proposed three-group, parallel, randomised controlled trial will recruit patients diagnosed in the past 4 months with breast, prostate, colorectal cancer or melanoma through their treating clinician. Patients and their partners will be randomised to (1) a minimal ethical care (MEC) condition-selected Cancer Council New South Wales booklets and a brochure for the Cancer Council Helpline, (2) Coping-Together generic-MEC materials, the six Coping-Together booklets and DVD, the Cancer Council Queensland relaxation audio CD and login to the Coping-Together website or (3) Coping-Together tailored-MEC materials, the Coping-Together DVD, the login to the website and only those Coping-Together booklet sections that pertain to their direct concerns. Anxiety (primary outcome), distress, depression, dyadic adjustment, quality of life, illness or caregiving appraisal, self-efficacy and dyadic and individual coping will be assessed before receiving the study material (ie, baseline) and again at 3, 6 and 12 months postbaseline. Intention-to-treat and per protocol analysis will be conducted. ETHICS AND DISSEMINATION:This study has been approved by the relevant local area health and University ethics committees. Study findings will be disseminated not only through peer-reviewed publications and conference presentations but also through educational outreach visits, publication of lay research summaries in consumer newsletters and publications targeting clinicians. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry ACTRN12613000491763 (03/05/2013).

journal_name

BMJ Open

journal_title

BMJ open

authors

Lambert SD,Girgis A,McElduff P,Turner J,Levesque JV,Kayser K,Mihalopoulos C,Shih ST,Barker D

doi

10.1136/bmjopen-2013-003337

subject

Has Abstract

pub_date

2013-07-24 00:00:00

issue

7

issn

2044-6055

pii

bmjopen-2013-003337

journal_volume

3

pub_type

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