Abstract
BackgroundWorldwide, 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.MethodsWe 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.DiscussionDIAdIC 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 registrationRegistration on ClinicalTrials.gov on 12/11/2020, identifier NCT04626349.Date and version identifier20211209_DIAdIC_Protocol_Article.
Highlights
Worldwide, millions of people with advanced cancer and their family caregivers are experiencing physical and psychological distress
By focusing on empowerment of the person with cancer and their family caregiver, the results of this randomized controlled trial (RCT) can contribute to the search for cost-effective novel interventions that can relieve constraints on professional healthcare
There are six dissemination objectives; (1) at least 6 Ph.D. dissertations, (2) publication in open access, green and gold international journals, (3) publication in national topicspecific journals, (4) communication to and interaction with all scientific stakeholders through active contributions at international conferences, (5) events and workshops organized at the premises of the DIAdIC partners and (6) an end-of-project conference. This project aims to study the effect of two psycho-educational interventions on emotional functioning and self-efficacy of patients with advanced cancer and their informal caregivers
Summary
Millions of people with advanced cancer and their family caregivers are experiencing physical and psychological distress. 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. A family caregiver is an unpaid, informal provider of care who has a personal connection to the patient (a friend, partner, ex-partner, sibling, parent, child, or other blood or non-blood relative) and provides one or more physical, social, practical, and emotional tasks [3] The caregiving role they take on can result in severe physical, psychological, and emotional health problems (co-suffering) and an overall decline in quality of life (QoL), which has major public healthcare and health resource implications [4]. A mix of socio-demographic items from differ- ✓ ent studies (self-constructed): - Sex, age, relationship status, living situation, having children, educational level, employment status, total monthly net income, financial difficulties related to physical condition or medical treatment, private medical insurance, religion, member of a minority ethnic group, dyad’s relationship For patients (14 items) For caregivers (15 items)
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