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Effectiveness of a nurse-delivered : study protocol for an international randomized controlled trial

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...

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Published in:BMC palliative care 2021-12, Vol.20 (1)
Main Authors: Matthys, Orphé, De Vleminck, Aline, Dierickx, Sigrid, Deliens, Luc, Van Goethem, Vincent, Lapeire, Lore, Groenvold, Mogens, Lund, Line, Arnfeldt, Caroline Moeller, Sengeloev, Lisa, Pappot, Helle, Johnsen, Anna Thit, Guerin, Suzanne, Larkin, Philip J, Jordan, Catherine, Connolly, Michael, D'Alton, Paul, Costantini, Massimo, Di Leo, Silvia, Gube, Turola, Elena, van der Heide, Agnes, Witkamp, Erika, Rietjens, Judith, van der Wel, Maaike, Brazil, Kevin, Prue, Gillian, Reid, Joanne, Scott, David, Bristowe, Katherine, Harding, Richard, Normand, Charles, May, Peter, Cronin, Catherine, Northouse, Laurel, Hudson, Peter, Cohen, Joachim
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container_title BMC palliative care
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creator Matthys, Orphé
De Vleminck, Aline
Dierickx, Sigrid
Deliens, Luc
Van Goethem, Vincent
Lapeire, Lore
Groenvold, Mogens
Lund, Line
Arnfeldt, Caroline Moeller
Sengeloev, Lisa
Pappot, Helle
Johnsen, Anna Thit
Guerin, Suzanne
Larkin, Philip J
Jordan, Catherine
Connolly, Michael
D'Alton, Paul
Costantini, Massimo
Di Leo, Silvia
Gube
Turola, Elena
van der Heide, Agnes
Witkamp, Erika
Rietjens, Judith
van der Wel, Maaike
Brazil, Kevin
Prue, Gillian
Reid, Joanne
Scott, David
Bristowe, Katherine
Harding, Richard
Normand, Charles
May, Peter
Cronin, Catherine
Northouse, Laurel
Hudson, Peter
Cohen, Joachim
description 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 registratio
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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. Keywords: Psychoeducational intervention, Dyadic, cancer, Family caregiver, Randomized clinical trial</description><identifier>ISSN: 1472-684X</identifier><identifier>EISSN: 1472-684X</identifier><identifier>DOI: 10.1186/s12904-021-00895-z</identifier><language>eng</language><publisher>BioMed Central Ltd</publisher><subject>Cancer ; Care and treatment ; Caregivers ; Educational aspects ; Health aspects ; Methods ; Oncologic nursing ; Oncology, Experimental ; Palliative treatment ; Psychological aspects ; Stress (Psychology) ; Technology application</subject><ispartof>BMC palliative care, 2021-12, Vol.20 (1)</ispartof><rights>COPYRIGHT 2021 BioMed Central Ltd.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids></links><search><creatorcontrib>Matthys, Orphé</creatorcontrib><creatorcontrib>De Vleminck, Aline</creatorcontrib><creatorcontrib>Dierickx, Sigrid</creatorcontrib><creatorcontrib>Deliens, Luc</creatorcontrib><creatorcontrib>Van Goethem, Vincent</creatorcontrib><creatorcontrib>Lapeire, Lore</creatorcontrib><creatorcontrib>Groenvold, Mogens</creatorcontrib><creatorcontrib>Lund, Line</creatorcontrib><creatorcontrib>Arnfeldt, Caroline Moeller</creatorcontrib><creatorcontrib>Sengeloev, Lisa</creatorcontrib><creatorcontrib>Pappot, Helle</creatorcontrib><creatorcontrib>Johnsen, Anna Thit</creatorcontrib><creatorcontrib>Guerin, Suzanne</creatorcontrib><creatorcontrib>Larkin, Philip J</creatorcontrib><creatorcontrib>Jordan, Catherine</creatorcontrib><creatorcontrib>Connolly, Michael</creatorcontrib><creatorcontrib>D'Alton, Paul</creatorcontrib><creatorcontrib>Costantini, Massimo</creatorcontrib><creatorcontrib>Di Leo, Silvia</creatorcontrib><creatorcontrib>Gube</creatorcontrib><creatorcontrib>Turola, Elena</creatorcontrib><creatorcontrib>van der Heide, Agnes</creatorcontrib><creatorcontrib>Witkamp, Erika</creatorcontrib><creatorcontrib>Rietjens, Judith</creatorcontrib><creatorcontrib>van der Wel, Maaike</creatorcontrib><creatorcontrib>Brazil, Kevin</creatorcontrib><creatorcontrib>Prue, Gillian</creatorcontrib><creatorcontrib>Reid, Joanne</creatorcontrib><creatorcontrib>Scott, David</creatorcontrib><creatorcontrib>Bristowe, Katherine</creatorcontrib><creatorcontrib>Harding, Richard</creatorcontrib><creatorcontrib>Normand, Charles</creatorcontrib><creatorcontrib>May, Peter</creatorcontrib><creatorcontrib>Cronin, Catherine</creatorcontrib><creatorcontrib>Northouse, Laurel</creatorcontrib><creatorcontrib>Hudson, Peter</creatorcontrib><creatorcontrib>Cohen, Joachim</creatorcontrib><title>Effectiveness of a nurse-delivered : study protocol for an international randomized controlled trial</title><title>BMC palliative care</title><description>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. 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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. Keywords: Psychoeducational intervention, Dyadic, cancer, Family caregiver, Randomized clinical trial</abstract><pub>BioMed Central Ltd</pub><doi>10.1186/s12904-021-00895-z</doi></addata></record>
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subjects Cancer
Care and treatment
Caregivers
Educational aspects
Health aspects
Methods
Oncologic nursing
Oncology, Experimental
Palliative treatment
Psychological aspects
Stress (Psychology)
Technology application
title Effectiveness of a nurse-delivered : study protocol for an international randomized controlled trial
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