TY - JOUR

T1 - Effectiveness of a nurse-delivered (FOCUS+) and a web-based (iFOCUS) psychoeducational intervention for people with advanced cancer and their family caregivers (DIAdIC)

T2 - study protocol for an international randomized controlled trial

AU - Matthys, Orphé

AU - De Vleminck, Aline

AU - Dierickx, Sigrid

AU - Deliens, Luc

AU - Van Goethem, Vincent

AU - Lapeire, Lore

AU - Groenvold, Mogens

AU - Lund, Line

AU - Arnfeldt, Caroline Moeller

AU - Sengeloev, Lisa

AU - Pappot, Helle

AU - Johnsen, Anna Thit

AU - Guerin, Suzanne

AU - Larkin, Philip J

AU - Jordan, Catherine

AU - Connolly, Michael

AU - D'Alton, Paul

AU - Costantini, Massimo

AU - Di Leo, Silvia

AU - Guberti, Monica

AU - Turola, Elena

AU - van der Heide, Agnes

AU - Witkamp, Erika

AU - Rietjens, Judith

AU - van der Wel, Maaike

AU - Brazil, Kevin

AU - Prue, Gillian

AU - Reid, Joanne

AU - Scott, David

AU - Bristowe, Katherine

AU - Harding, Richard

AU - Normand, Charles

AU - May, Peter

AU - Cronin, Catherine

AU - Northouse, Laurel

AU - Hudson, Peter

AU - Cohen, Joachim

N1 - © 2021. The Author(s).

PY - 2021/12/28

Y1 - 2021/12/28

N2 - 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.

AB - 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.

KW - Caregivers

KW - Humans

KW - Internet

KW - Multicenter Studies as Topic

KW - Neoplasms/therapy

KW - Psychosocial Support Systems

KW - Quality of Life

KW - Randomized Controlled Trials as Topic

KW - Randomized clinical trial

KW - Family caregiver

KW - Dyadic

KW - Psychoeducational intervention

KW - cancer

UR - http://www.scopus.com/inward/record.url?scp=85121835898&partnerID=8YFLogxK

U2 - 10.1186/s12904-021-00895-z

DO - 10.1186/s12904-021-00895-z

M3 - Journal article

C2 - 34963453

VL - 20

SP - 193

JO - BMC Palliative Care

JF - BMC Palliative Care

SN - 1472-684X

IS - 1

M1 - 193

ER -