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
Authors: Matthys Orphé , De Vleminck Aline , Dierickx Sigrid , Deliens Luc , Van Goethem Vincent , Lapeire Lore , Groenvold Mogens , Lund Line , Arnfeldt Caroline Moeller , Sengeloev Lisa , Pappot Helle , Johnsen Anna Thit , Guerin Suzanne , Larkin Philip J. , Jordan Catherine , Connolly Michael , D’Alton Paul , Costantini Massimo , Di Leo Silvia , Guberti Monica , Turola Elena , van der Heide Agnes , Witkamp Erika , Rietjens Judith , van der Wel Maaike , Brazil Kevin , Prue Gillian , Reid Joanne , Scott David , Bristowe Katherine , Harding Richard , Normand Charles , May Peter , Cronin Catherine , Northouse Laurel , Hudson Peter , Cohen Joachim 
Published: December 2021

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.