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 Livingston,Kate Gunn,Mari Botti,Cathy Mihalopoulos,Richard H Osborne,Jacquie Chirgwin,Sean Mcguigan,David M Ashley,Leila Heckel,Melinda Williams

doi:10.1186/1472-6963-14-5

Abstract

BackgroundCarers 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/DesignThis 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.DiscussionThis 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 registrationAustralian New Zealand Clinical Trials Registry ACTRN: 12613000731796.

Highlights

IntroductionThe 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
Carers provide extended and often unrecognized support to people with cancer
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

Summary

Introduction

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. Carer burden is conceptualized as a demanding activity, or a negative reaction to activities related to caring for the patient [11,12] These activities include providing practical day-to-day physical care and the resulting emotional reactions of the carer to the caregiving role, such as worry, depression, anxiety, frustration or fatigue [12]. Recent research highlighted that up to 70% of carers experienced depression [15,16] with 39% reporting significant depression compared to 23% of patients [17] This has major implications for carers of more than 120,000 Australians estimated to be diagnosed each year [18]. Psychological distress and depression are magnified if the carer is a spouse or adult child of the person with cancer and stage of disease [20,21]

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