- Title
- 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
- Creator
- Livingston, Patricia M.; Osborne, Richard H.; Botti, Mari; Mihalopoulos, Cathy; McGuigan, Sean; Heckel, Leila; Gunn, Kate; Chirgwin, Jacquie; Ashley, David M.; Williams, Melinda
- Relation
- National Health and Medical Research Council.GNT1044400 RM24525
- Relation
- BMC Health Services Research Vol. 14
- Publisher Link
- http://dx.doi.org/10.1186/1472-6963-14-5
- Publisher
- BioMed Central
- Resource Type
- journal article
- Date
- 2014
- Description
- 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.
- Subject
- carers; depression; randomised controlled trial; cancer
- Identifier
- http://hdl.handle.net/1959.13/1060430
- Identifier
- uon:16776
- Identifier
- ISSN:1472-6963
- Language
- eng
- Full Text
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