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Open Access Study protocol

Efficacy and cost-effectiveness of an outcall program to reduce carer burden and depression among carers of cancer patients [PROTECT]: rationale and design of a randomized controlled trial

Patricia M Livingston1*, Richard H Osborne1, Mari Botti12, Cathy Mihalopoulos1, Sean McGuigan2, Leila Heckel1, Kate Gunn3, Jacquie Chirgwin456, David M Ashley17 and Melinda Williams8

Author Affiliations

1 Faculty of Health, Deakin University, 221 Burwood Highway, Burwood, Victoria 3125, Australia

2 Epworth HealthCare, Richmond, Victoria, Australia

3 Cancer Council SA, Adelaide, South Australia, Australia

4 Eastern Health, Department of Oncology, Box Hill, Victoria, Australia

5 University of Newcastle, Newcastle, New South Wales, Australia

6 Monash University, Melbourne, Victoria, Australia

7 Barwon Health, Melbourne, Victoria, Australia

8 Barwon South Western Regional Integrated Cancer Service, Geelong, Victoria, Australia

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BMC Health Services Research 2014, 14:5  doi:10.1186/1472-6963-14-5

Published: 6 January 2014

Abstract

Background

Carers provide extended and often unrecognized support to people with cancer. The aim of this study is to test the hypothesis that excessive carer burden is modifiable through a telephone outcall intervention that includes supportive care, information and referral to appropriate psycho-social services. Secondary aims include estimation of changes in psychological health and quality of life. The study will determine whether the intervention reduces unmet needs among patient dyads. A formal economic program will also be conducted.

Methods/Design

This study is a single-blind, multi-centre, randomized controlled trial to determine the efficacy and cost-efficacy of a telephone outcall program among carers of newly diagnosed cancer patients. A total of 230 carer/patient dyads will be recruited into the study; following written consent, carers will be randomly allocated to either the outcall intervention program (n = 115) or to a minimal outcall / attention control service (n = 115). Carer assessments will occur at baseline, at one and six months post-intervention. The primary outcome is change in carer burden; the secondary outcomes are change in carer depression, quality of life, health literacy and unmet needs. The trial patients will be assessed at baseline and one month post-intervention to determine depression levels and unmet needs. The economic analysis will include perspectives of both the health care sector and broader society and comprise a cost-consequences analysis where all outcomes will be compared to costs.

Discussion

This study will contribute to our understanding on the potential impact of a telephone outcall program on carer burden and provide new evidence on an approach for improving the wellbeing of carers.

Trial registration

Australian New Zealand Clinical Trials Registry ACTRN: 12613000731796.