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Research methods
Protocol
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
  1. Sylvie D Lambert1,
  2. Afaf Girgis2,
  3. Patrick McElduff3,
  4. Jane Turner4,
  5. Janelle V Levesque2,
  6. Karen Kayser5,
  7. Cathrine Mihalopoulos6,
  8. Sophy T F Shih6,
  9. Daniel Barker3
  1. 1Ingram School of Nursing, McGill University, Montreal, Canada
  2. 2Translational Cancer Research Unit, Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, UNSW Medicine, The University of New South Wales, Liverpool, New South Wales, Australia
  3. 3School of Medicine and Public Health, John Hunter Hospital, The University of Newcastle, Newcastle, New South Wales, Australia
  4. 4The University of Queensland, Brisbane, Queensland, Australia
  5. 5Kent School of Social Work, University of Louisville, Louisville, Kentucky, USA
  6. 6Deakin Health Economics, Faculty of Health, Deakin University, Burwood, Victoria, Australia
  1. Correspondence to Dr Sylvie Lambert; sylvie.d.lambert{at}gmail.com

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)

  • Mental health
  • Public health
  • Statistics & Research Methods

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/

https://doi.org/10.1136/bmjopen-2013-003337

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