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

• DOI: 10.1186/s12904-021-00895-z
• Publication Date: 2021-12-28T11:02:44Z
• Authors: Orphé Matthys; Aline De Vleminck; Sigrid Dierickx; Luc Deliens; Vincent Van Goethem; Lore Lapeire; Mogens Groenvold; Line Lund; Caroline Moeller ...; Lisa Sengeloev; Helle Pappot; Anna Thit Johnsen; Suzanne Guerin; Philip J. Larkin; Catherine Jordan; Michael Connolly; Paul D’Alton; Massimo Costantini; Silvia Di Leo; Monica Guberti; Elena Turola; Agnes van der Heide; Erika Witkamp; Judith Rietjens; Maaike van der Wel; Kevin Brazil; Gillian Prue; Joanne Reid; David Scott; Katherine Bristowe; Richard Harding; Charles Normand; Peter May; Catherine Cronin; Laurel Northouse; Peter Hudson; Joachim Cohen
• Keywords: Pain medicine; Family Caregivers

Abstract Background Worldwide, millions of people with advanced cancer and their family caregivers are experiencing physical psychological distress. Psychosocial support education can reduce distress prevent avoidable healthcare resource use. To date, we lack knowledge from large-scale studies on which interventions generate positive outcomes for informal caregivers’ quality life. This protocol describes the DIAdIC study that will evaluate effectiveness two psychosocial educational aimed at improving patient-family caregiver dyads’ emotional functioning self-efficacy. Methods We conduct an international multicenter three-arm randomized controlled trial in Belgium, Denmark, Ireland, Italy, The Netherlands, United Kingdom. In each country, 156 dyads (936 total) be to one arms: 1) a nurse-led face-to-face intervention (FOCUS+), 2) web-based (iFOCUS) or 3) control group (care as usual). offer tailored psychoeducational dyads. consists home visits online video session is completed independently by dyad four sessions. based FOCUS intervention, developed USA, addresses five core components: involvement, optimistic outlook, coping effectiveness, uncertainty reduction, symptom management. adapted European context. primary self-efficacy patient caregiver, respectively. secondary life, benefits illness, coping, dyadic communication, ways giving caregiver. Discussion aims develop cost-effective integrate principles early palliative care into standard care. cross-country setup six countries allows comparison different systems across Europe. By focusing empowerment person results this RCT contribute search novel relieve constraints professional healthcare. Trial registration Registration ClinicalTrials.gov 12/11/2020, identifier NCT04626349 . Date version 20211209_DIAdIC_Protocol_Article.