Background
Worldwide, millions of people with advanced cancer and their family caregivers are experiencing physical and psychological distress. Psychosocial support and education can reduce distress and prevent avoidable healthcare resource use. To date, we lack knowledge from large-scale studies on which interventions generate positive outcomes for people with cancer and their informal caregivers’ quality of life. This protocol describes the DIAdIC study that will evaluate the effectiveness of two psychosocial and educational interventions aimed at improving patient-family caregiver dyads’ emotional functioning and self-efficacy.
Methods
We will conduct an international multicenter three-arm randomized controlled trial in Belgium, Denmark, Ireland, Italy, The Netherlands, and the United Kingdom. In each country, 156 dyads (936 in total) of people with advanced cancer and their family caregiver will be randomized to one of the study arms: 1) a nurse-led face-to-face intervention (FOCUS+), 2) a web-based intervention (iFOCUS) or 3) a control group (care as usual). The two interventions offer tailored psychoeducational support for patient-family caregiver dyads. The nurse-led face-to-face intervention consists of two home visits and one online video session and the web-based intervention is completed independently by the patient-family caregiver dyad in four online sessions. The interventions are based on the FOCUS intervention, developed in the USA, that addresses five core components: family involvement, optimistic outlook, coping effectiveness, uncertainty reduction, and symptom management. The FOCUS intervention will be adapted to the European context. The primary outcomes are emotional functioning and self-efficacy of the patient and the family caregiver, respectively. The secondary outcomes are quality of life, benefits of illness, coping, dyadic communication, and ways of giving support of the patient and family caregiver.
Discussion
DIAdIC aims to develop cost-effective interventions that integrate principles of early palliative care into standard care. The cross-country setup in six European countries allows for comparison of effectiveness of the interventions in different healthcare systems across Europe. By focusing on empowerment of the person with cancer and their family caregiver, the results of this RCT can contribute to the search for cost-effective novel interventions that can relieve constraints on professional healthcare.
Trial registration
Registration on ClinicalTrials.gov on 12/11/2020, identifier NCT04626349.
Date and version identifier
20211209_DIAdIC_Protocol_Article.
Background: Due to medical advances and an increasingly ageing population, the number of people living with a serious illness is rising. This has major implications for the burden on family members of assisting with care. Support of family caregivers by healthcare professionals is needed to ensure they can provide quality care for people with serious illness. Aim: To investigate how family caregivers of people with serious illness are supported by healthcare professionals in their caregiving tasks. Design/Participants: Population-based cross-sectional survey of bereaved family caregivers of people with serious illness ( N = 3000) who cared for a person who had died 2–6 months before the sample was drawn (November 2019), as identified through three sickness funds in Flanders, Belgium. The survey explored support from healthcare professionals for family caregivers 3 months prior to bereavement. Results: Response rate was 55.0%. Most family caregivers received support from one or more healthcare professionals for family caregiving tasks, ranging from 71% for promoting social interaction to 95% for managing symptoms. The type of support mostly involved providing information. Use of palliative care services was the strongest predictor of such support across physical, psychosocial and practical tasks. Conclusion: Most family caregivers of those with serious illness get some form of support from healthcare professionals for their tasks. However, an empowering support strategy for example one aimed at increasing self-efficacy of the family caregiver is rare and end-of-life communication between healthcare professionals and family caregivers needs improvement.
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