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
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
BMC Health Services Research 2014, 14:5 doi:10.1186/1472-6963-14-5Published: 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.
Australian New Zealand Clinical Trials Registry ACTRN: 12613000731796.