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

ABSTRACT: Informal 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.Cancer 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.The 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.While 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.ACTRN12613000731796 ; prospectively registered on 02/07/2013.

SUBMITTER: Heckel L

PROVIDER: S-EPMC5759190 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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

Heckel Leila L Fennell Kate M KM Reynolds John J Boltong Anna A Botti Mari M Osborne Richard H RH Mihalopoulos Cathrine C Chirgwin Jacquie J Williams Melinda M Gaskin Cadeyrn J CJ Ashley David M DM Livingston Patricia M PM

BMC cancer 20180108 1

<h4>Background</h4>Informal 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.<h4>Methods</h4>Canc ...[more]

PMID: 29310613

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Project description:It is estimated that global dementia rates will more than triple by 2050 and result in a staggering economic burden on families and societies. Dementia carries significant physical, psychological and social challenges for individuals and caregivers. Informal caregiving is common and increasing as more people with dementia are being cared for at home instead of in nursing homes. Caregiver burden is associated with lower perceived health, lower social coherence, and increased risk of morbidity and mortality. The aim of this trial is to evaluate the effects of information and communication technology (ICT) on caregiver burden among informal caregivers of people with dementia by reducing the need for supervision.This randomized controlled trial aims to recruit 320 dyads composed of people with dementia living in community settings and their primary informal caregivers. In the intervention group, people with dementia will have a home monitoring kit installed in their home while dyads in the control group will receive usual care. The ICT kit includes home-leaving sensors, smoke and water leak sensors, bed sensors, and automatic lights that monitor the individual's behavior. Alerts (text message and/or phone call) will be sent to the caregiver if anything unusual occurs. All study dyads will receive three home visits by project administrators who have received project-specific training in order to harmonize data collection. Home visits will take place at enrollment and 3 and 12 months following installation of the ICT kit. At every home visit, a standardized questionnaire will be administered to all dyads to assess their health, quality of life and resource utilization. The primary outcome of this trial is the amount of informal care support provided by primary informal caregivers to people with dementia.This is the first randomized controlled trial exploring the implementation of ICT for people with dementia in a large sample in Sweden and one of the first at the international level. Results hold the potential to inform regional and national policy-makers in Sweden and beyond about the cost-effectiveness of ICT and its impact on caregiver burden.ClinicalTrials.gov, NCT02733939 . Registered on 10 March 2016.

Project description:BackgroundAustralia has one of the highest rates of methamphetamine (MA) use in the world; however, uptake of in-person psychological treatment remains extremely low due to numerous individual (e.g. stigma, shame) and structural (e.g. service accessibility, geographical location) barriers to accessing care. Telephone-delivered interventions are ideally placed to overcome many of the known barriers to treatment access and delivery. This randomised controlled trial (RCT) will examine the efficacy of a standalone, structured telephone-delivered intervention to reduce MA problem severity and related harms.MethodsThis study is a double-blind, parallel-group RCT. We will recruit 196 ± 8 individuals with mild to moderate MA use disorder from across Australia. After eligibility and baseline assessments, participants will be randomly allocated to receive either the Ready2Change-Methamphetamine (R2C-M) intervention (n = 98 ± 4; four to six telephone-delivered intervention sessions, R2C-M workbooks and MA information booklet) or control (n = 98 ± 4; four to six ≤5-min telephone check-ins and MA information booklet including information on accessing further support). Telephone follow-up assessments will occur at 6 weeks and 3, 6 and 12 months post-randomisation. The primary outcome is change in MA problem severity (Drug Use Disorders Identification Test, DUDIT) at 3 months post-randomisation. Secondary outcomes are as follows: MA problem severity (DUDIT) at 6 and 12 months post-randomisation, amount of methamphetamine used, methamphetamine use days, methamphetamine use disorder criteria met, cravings, psychological functioning, psychotic-like experiences, quality of life and other drug use days (at some or all timepoints of 6 weeks and 3, 6 and 12 months post-randomisation). Mixed-methods program evaluation will be performed and cost-effectiveness will be examined.DiscussionThis study will be the first RCT internationally to assess the efficacy of a telephone-delivered intervention for MA use disorder and related harms. The proposed intervention is expected to provide an effective, low-cost, scalable treatment for individuals otherwise unlikely to seek care, preventing future harms and reducing health service and community costs.Trial registrationClinicalTrials.gov NCT04713124 . Pre-registered on 19 January 2021.

Dataset Information

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

Publications

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

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