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.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Faculty of Health, Deakin University, 221 Burwood Highway, Burwood, Victoria 3125, Australia. trish.livingston@deakin.edu.au.
authors.forename: Patricia M
authors.initials: PM
authors.lastname: Livingston
authors.forename: Richard H
authors.initials: RH
authors.lastname: Osborne
authors.forename: Mari
authors.initials: M
authors.lastname: Botti
authors.forename: Cathy
authors.initials: C
authors.lastname: Mihalopoulos
authors.forename: Sean
authors.initials: S
authors.lastname: McGuigan
authors.forename: Leila
authors.initials: L
authors.lastname: Heckel
authors.forename: Kate
authors.initials: K
authors.lastname: Gunn
authors.forename: Jacquie
authors.initials: J
authors.lastname: Chirgwin
authors.forename: David M
authors.initials: DM
authors.lastname: Ashley
authors.forename: Melinda
authors.initials: M
authors.lastname: Williams
mesh_terms: D017028:Caregivers / Q000191:economics / Q000523:psychology*; D017281:Cost of Illness; D003362:Cost-Benefit Analysis; D003863:Depression / Q000517:prevention & control*; D006801:Humans; D009369:Neoplasms / Q000628:therapy*; D015397:Program Evaluation; D011788:Quality of Life / Q000523:psychology; D016037:Single-Blind Method; D012944:Social Support; D013689:Telephone