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.

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State: Public
Version: author
License: CC BY 4.0
Serval ID
serval:BIB_8E819E4EA5CB
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
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.
Journal
BMC palliative care
Author(s)
Matthys O., De Vleminck A., Dierickx S., Deliens L., Van Goethem V., Lapeire L., Groenvold M., Lund L., Arnfeldt C.M., Sengeloev L., Pappot H., Johnsen A.T., Guerin S., Larkin P.J., Jordan C., Connolly M., D'Alton P., Costantini M., Di Leo S., Guberti M., Turola E., van der Heide A., Witkamp E., Rietjens J., van der Wel M., Brazil K., Prue G., Reid J., Scott D., Bristowe K., Harding R., Normand C., May P., Cronin C., Northouse L., Hudson P., Cohen J.
ISSN
1472-684X (Electronic)
ISSN-L
1472-684X
Publication state
Published
Issued date
28/12/2021
Peer-reviewed
Oui
Volume
20
Number
1
Pages
193
Language
english
Notes
Publication types: Clinical Trial Protocol ; Journal Article
Publication Status: epublish
Abstract
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.
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.
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.
Registration on ClinicalTrials.gov on 12/11/2020, identifier NCT04626349 .
20211209_DIAdIC_Protocol_Article.
Keywords
Caregivers, Humans, Internet, Multicenter Studies as Topic, Neoplasms/therapy, Psychosocial Support Systems, Quality of Life, Randomized Controlled Trials as Topic, Dyadic, Family caregiver, Psychoeducational intervention, Randomized clinical trial, cancer
Pubmed
Web of science
Open Access
Yes
Create date
07/01/2022 19:27
Last modification date
23/11/2022 7:51
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