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Open Access Study protocol

Beating the blues after Cancer: randomised controlled trial of a tele-based psychological intervention for high distress patients and carers

Suzanne K Chambers12*, Afaf Girgis3, Stefano Occhipinti1, Sandy Hutchison1, Jane Turner4, Rob Carter5 and Jeff Dunn12

Author Affiliations

1 Griffith Institute for Health and Medical Research, Griffith University, Brisbane, Australia

2 Viertel Centre for Research in Cancer Control, Cancer Council Queensland, Brisbane, Australia

3 Centre for Health Research & Psycho-oncology, Cancer Council NSW & University of Newcastle, Newcastle, Australia

4 School of Medicine, University of Queensland, Brisbane, Australia

5 Deakin Health Economics, Deakin University, Melbourne, Australia

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BMC Cancer 2009, 9:189  doi:10.1186/1471-2407-9-189

Published: 17 June 2009

Abstract

Background

The diagnosis and treatment of cancer is a major life stress such that approximately 35% of patients experience persistent clinically significant distress and carers often experience even higher distress than patients. This paper presents the design of a two arm randomised controlled trial with patients and carers who have elevated psychological distress comparing minimal contact self management vs. an individualised tele-based cognitive behavioural intervention.

Methods/design

140 patients and 140 carers per condition (560 participants in total) will been recruited after being identified as high distress through caller screening at two community-based cancer helplines and randomised to 1) a single 30-minute telephone support and education session with a nurse counsellor with self management materials 2) a tele-based psychologist delivered five session individualised cognitive behavioural intervention. Session components will include stress reduction, problem-solving, cognitive challenging and enhancing relationship support and will be delivered weekly. Participants will be assessed at baseline and 3, 6 and 12 months after recruitment. Outcome measures include: anxiety and depression, cancer specific distress, unmet psychological supportive care needs, positive adjustment, overall Quality of life.

Discussion

The study will provide recommendations about the efficacy and potential economic value of minimal contact self management vs. tele-based psychologist delivered cognitive behavioural intervention to facilitate better psychosocial adjustment and mental health for people with cancer and their carers.

Trial Registration

ACTRN12609000301268.