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

Orphé Matthys, Aline De Vleminck, Sigrid Dierickx, Luc Deliens, Vincent Van Goethem, Lore Lapeire, Mogens Groenvold, Line Lund, Caroline Moeller Arnfeldt, 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 GubertiElena 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

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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.

Original languageEnglish
Article number193
Number of pages18
JournalBMC palliative care
Volume20
Issue number1
DOIs
Publication statusPublished - 28 Dec 2021

Bibliographical note

Funding Information:
Kim Eecloo, Aurelie Joos, Yuliana Gatsolaeva, Julie Ling, Isabelle Manneh, Lydia Makaroff, European Cancer Patient Coalition (ECPC), European Association for Palliative Care (EAPC).

Funding Information:
This study is part of the DIAdIC project that has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 825722. The funder of the trial has no role in the collection, management, analysis, and interpretation of data; in the writing of the report; nor in the decision to submit the report for publication.

Publisher Copyright:
© 2021, The Author(s).

Keywords

  • cancer
  • Dyadic
  • Family caregiver
  • Psychoeducational intervention
  • Randomized clinical trial

ASJC Scopus subject areas

  • Medicine(all)

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