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

BMC Palliative Care

Catherine Cronin¹  Charles Normand²  Peter May³  Peter Hudson⁴  Maaike van der Wel⁵  Judith Rietjens⁵  Erika Witkamp⁵  Agnes van der Heide⁵  Lore Lapeire⁶  Lisa Sengeloev⁷  Helle Pappot⁸  Line Lund⁹  Caroline Moeller Arnfeldt⁹  Mogens Groenvold⁹  Sigrid Dierickx^1,10  Vincent Van Goethem^1,10  Aline De Vleminck^1,10  Luc Deliens^1,10  Joachim Cohen^1,10  Orphé Matthys^1,10  Richard Harding^1,11  Katherine Bristowe^1,11  Monica Guberti^1,12  Philip J. Larkin^1,13  Silvia Di Leo^1,14  Gillian Prue^1,15  Joanne Reid^1,15  David Scott^1,15  Kevin Brazil^1,15  Michael Connolly^1,16  Laurel Northouse^1,17  Massimo Costantini^1,18  Elena Turola^1,18  Catherine Jordan^1,19  Suzanne Guerin^1,19  Paul D’Alton^1,19  Anna Thit Johnsen^2,20 

[1] Centre for Health Policy and Management, Trinity College Dublin, Dublin, Ireland;Centre for Health Policy and Management, Trinity College Dublin, Dublin, Ireland;Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, London, UK;Centre for Health Policy and Management, Trinity College Dublin, Dublin, Ireland;The Irish Longitudinal Study on Ageing, Dublin, Ireland;Centre for Palliative Care, St Vincent’s Hospital, Melbourne, Australia;Vrije University Brussels (VUB), Brussels, Belgium;Deparmtent of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands;Department of Medical Oncology, Ghent University Hospital, Ghent, Belgium;Department of Oncology, Herlev Gentofte University Hospital, Herlev, Denmark;Department of Oncology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark;Department of Public Health, University of Copenhagen and Palliative Care Research Unit, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark;End-of-life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University, Brussels, Belgium;King’s College London, Florence Nightingale Faculty of Nursing Midwifery and Palliative Care, Cicely Saunders Institute, London, UK;Nursing & Health Care Professions Directorate, Azienda USL-IRCCS, Reggio Emilia, Italy;Palliative and Supportive Care Service, Chair of Palliative Care Nursing, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland;Psycho-oncology Unit, Azienda USL - IRCCS di Reggio Emilia, Reggio Emilia, Italy;School of Nursing and Midwifery, Queen’s University of Belfast, 97 Lisburn Road, BT9 7BL, Belfast, Northern Ireland, UK;School of Nursing, Midwifery and Health Systems, University College Dublin, Dublin, Ireland;School of Nursing, University of Michigan, Ann Arbor, MI, USA;Scientific Directorate, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy;UCD School of Psychology, University College Dublin, Belfield, Ireland;University of Southern Denmark, Odense, Denmark;

关键词: Psychoeducational intervention;    Dyadic;    cancer;    Family caregiver;    Randomized clinical trial;   

DOI  :  10.1186/s12904-021-00895-z

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY