Efficacy and Cost-Effectiveness of a Telephone Outcall Program to Reduce Carer Burden and Depression Among Carers of Cancer Patients [PROTECT]. Rationale and Design of a Multi-State, Multi-Centre Randomised Controlled Trial (#338)
Carers of cancer patients often provide extended and uncompensated support in the management of side effects and symptoms and in the provision of practical assistance with activities of daily living. This demanding role can result in excessive carer burden with up to 70% of carers experiencing depression and up to 50% reporting anxiety. The primary aim of this single-blind, multi-centre, randomised, controlled trial is to determine whether a low-cost telephone outcall intervention reduces ‘carer burden’ in carers of newly diagnosed cancer patients. Secondary aims are to measure the effects of the intervention on the psychological health, quality of life and health literacy of carers, as well as the unmet needs in cancer patients. A formal economic evaluation will also be conducted.
A total of 230 carer/patient dyads will be recruited; dyads will be randomised in a 1:1 ratio to either the outcall intervention program (n=115) or an alternate minimal outcall service/attention control (n=115). Carer assessments will occur at baseline, at one and six months post-intervention. Patients will be assessed at baseline and one month post intervention. The economic analysis will take the perspectives of both the health care sector and broader society. The telephone intervention will be conducted by Cancer Council Helpline nurses and comprises 3 consecutive outcalls: at 7-10 days post referral, 1 month after the first intervention and 3 months after the second intervention. Carers will be screened for distress and provided with supportive care, information and referral to appropriate psycho-social services.
Our trial will measure the effects of a community based telephone outcall program on carer burden, quality of life and well-being.