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.

Published online

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Livingston, PM; Osborne, RH; Botti, M; Mihalopoulos, C; McGuigan, S; Heckel, L; Gunn, K; Chirgwin, J; Ashley, DM; Williams, M

Published Date

  • January 6, 2014

Published In

Volume / Issue

  • 14 /

Start / End Page

  • 5 -

PubMed ID

  • 24393305

Pubmed Central ID

  • 24393305

Electronic International Standard Serial Number (EISSN)

  • 1472-6963

Digital Object Identifier (DOI)

  • 10.1186/1472-6963-14-5


  • eng

Conference Location

  • England