Efficacy of a telephone outcall program to reduce caregiver burden among caregivers of cancer patients [PROTECT]: a randomised controlled trial

Abstract

BackgroundInformal caregivers provide extended support to people with cancer but they receive little support from the health care system to assist them in their caring role. The aim of this single-blind, multi-centre, randomised controlled trial was to test the efficacy of a telephone outcall program to reduce caregiver burden and unmet needs, and improve psychological well-being among cancer caregivers, as well as evaluating the potential impact on patient outcomes.MethodsCancer patient/caregiver dyads (N = 216) were randomised to a telephone outcall program (n = 108) or attention control group (n = 108). The primary outcome was self-reported caregiver burden. Secondary endpoints included depressive symptoms, unmet needs, self-esteem, self-empowerment, and health literacy. Data were collected at baseline and at both 1 and 6 months post-intervention. An intention to treat analysis was performed.ResultsThe intervention had no effect on the primary outcome (caregiver burden), but reduced the number of caregiver unmet needs (intervention group baseline, mean = 2.66, 95% confidence interval (CI) [1.91–3.54]; intervention group 1 month post intervention, mean = 0.85, 95%CI [0.42–1.44]; control group baseline, mean = 1.30 95%CI [0.80–1.94], control group 1 month post intervention, mean = 1.02 95%CI [0.52–1.69]; p = 0.023). For caregivers at risk for depression, the intervention had a significant effect on caregivers’ confidence in having sufficient information to manage their health (p = 0.040). No effects were found for patients’ depressive symptoms, unmet needs, self-empowerment, and other health literacy domains.ConclusionsWhile caregiver burden was not reduced, the outcall program was effective in reducing unmet needs in caregivers. Provision of cancer information and support via a telephone service may represent a feasible approach to reducing unmet needs among cancer caregiver populations.Trial registrationACTRN12613000731796; prospectively registered on 02/07/2013.Electronic supplementary materialThe online version of this article (10.1186/s12885-017-3961-6) contains supplementary material, which is available to authorized users.

An economic evaluation of a telephone outcall intervention for informal carers of cancer patients in Australia: An assessment of costs and quality‐adjusted‐life‐years

“…The economic evaluation was conducted alongside the main trial . As such, resource usage and HRQoL data were collected concurrently with primary and secondary outcome data at baseline, 1 month (FU1), and 6 months (FU2) post intervention.…”

“…Adult cancer patient/carer dyads were recruited if the patient was diagnosed with a primary cancer diagnosis and was attending cycle 2 to 5 of adjuvant chemotherapy or fraction 2 to 10 of radiotherapy treatment (ie, treatment with curative intent). Patients with any type of cancer were recruited to address the diversity of carer needs and to allow findings to be applied to the broader cancer carer population . Carers were defined as the individual providing the most support to the cancer patient throughout the course of the illness.…”

“…The intervention arm comprised of three 131120 information and support service outcalls to carers from a trained oncology nurse, with outcall 1 at baseline (7‐10 days post randomisation), outcall 2 at 1 month post baseline, and outcall 3 at 4 months post baseline . The nurses followed a standardised protocol and checklist during each outcall, consisting of the administration of the Distress Thermometer (DT) followed by a tailored discussion on issues relevant to the carer.…”

“…The nurses followed a standardised protocol and checklist during each outcall, consisting of the administration of the Distress Thermometer (DT) followed by a tailored discussion on issues relevant to the carer. The tailored discussion comprised of six topics (psychological distress, health literacy, health, family support, financial problems, and practical issues), raised by the 131120 nurse to address potential unmet carer needs and to direct carers to available health care resources if required . Up to seven call attempts could be made per each of the three outcalls before the carer was declared absent for that outcall.…”

“…The control arm intervention consisted of three outcalls conducted by the project research coordinators in Adelaide and Melbourne to carers at the same time points as the intervention arm . Seven call attempts were also made per outcall.…”