Effectiveness of a nurse-delivered (FOCUS+) and a web-based (iFOCUS) psychoeducational intervention for people with advanced cancer and their family caregivers (DIAdIC): study protocol for an international randomized controlled trial

Abstract

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.

Effectiveness and moderators of cancer patient-caregiver dyad interventions in improving psychological distress: A systematic review and meta-analysis

“…It should be clear that online interventions are not only beneficial but also not inferior to face-to-face ones. 62 , 63 As interventions via the Internet or videoconferences are more creative and shorter, more large-sample and high-quality studies are needed in the future to compare these two forms of interventions.…”

Improving the Well-Being of People With Advanced Cancer and Their Family Caregivers: Protocol for an Effectiveness-Implementation Trial of a Dyadic Digital Health Intervention (FOCUSau)

“…The strong empirical base and utility of the FOCUS (USA) intervention have been acknowledged by the European Union (EU) through successful grant funding awarded to test European-adapted versions of both programs (in-person (FOCUS+) and digital (iFOCUS) in a Phase III trial, currently being conducted across six countries (England, Ireland, Belgium, Denmark, Netherlands and Italy) [39,40,41] .…”

“…Data collection will be completed separately by the patient and carer (regardless of allocation). The data collection points, outcomes and measures have been selected in accordance with those used in the aforementioned EU trial to enhance international comparison and potential generalisability [39] .…”

A self-management psychoeducational eHealth program to support and empower people with advanced cancer and their family caregivers: Development using the scrum methodology

“…As part of the international DIAdIC project which involves six European countries (Belgium, The Netherlands, Denmark, Italy, The United Kingdom, and Ireland) we developed two adaptations of the US-based FOCUS program, namely a face-to-face program named FOCUS+ and a web-based program iFOCUS and will determine whether these two adaptations could effectively improve the emotional well-being and self-efficacy of people with advanced cancer and their family caregivers ( Matthys et al, 2021 ). In the present article we specifically report on the development process of the iFOCUS program.…”