Open Access Open Badges 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



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.


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.


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.