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 Guberti; Elena 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

doi:10.1186/s12904-021-00895-z

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

Research output: Contribution to journal › Article › peer-review

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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 language	English
Article number	193
Number of pages	18
Journal	BMC Palliative Care
Volume	20
Issue number	1
DOIs	https://doi.org/10.1186/s12904-021-00895-z
Publication status	Published - 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

General Medicine

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Efectiveness 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
© 2021 The Authors. This is an open access article published under a Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium, provided the author and source are cited.
Final published version, 1.33 MBLicence: CC BY
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
Copyright 2021 the authors. This is an open access article published under a Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium, provided the author and source are cited.
Final published version, 1.33 MBLicence: CC BY

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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., ... Cohen, J. (2021). 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, 20(1), Article 193. https://doi.org/10.1186/s12904-021-00895-z

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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",

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.",

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author = "Orph{\'e} Matthys and {De Vleminck}, Aline and Sigrid Dierickx and Luc Deliens and {Van Goethem}, Vincent and Lore Lapeire and Mogens Groenvold and Line Lund and Arnfeldt, {Caroline Moeller} and Lisa Sengeloev and Helle Pappot and Johnsen, {Anna Thit} and Suzanne Guerin and Larkin, {Philip J} and Catherine Jordan and Michael Connolly and Paul D'Alton and Massimo Costantini and {Di Leo}, Silvia and Monica Guberti and Elena Turola and {van der Heide}, Agnes and Erika Witkamp and Judith Rietjens and {van der Wel}, Maaike and Kevin Brazil and Gillian Prue and Joanne Reid and David Scott and Katherine Bristowe and Richard Harding and Charles Normand and Peter May and Catherine Cronin and Laurel Northouse and Peter Hudson and Joachim Cohen",

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{\textquoteright}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: {\textcopyright} 2021, The Author(s).",

year = "2021",

month = dec,

day = "28",

doi = "10.1186/s12904-021-00895-z",

language = "English",

volume = "20",

journal = "BMC Palliative Care",

issn = "1472-684X",

publisher = "BioMed Central",

number = "1",

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Matthys, O, De Vleminck, A, Dierickx, S, Deliens, L, Van Goethem, V, Lapeire, L, Groenvold, M, Lund, L, Arnfeldt, CM, Sengeloev, L, Pappot, H, Johnsen, AT, Guerin, S, Larkin, PJ, 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 2021, '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, vol. 20, no. 1, 193. https://doi.org/10.1186/s12904-021-00895-z

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. / Matthys, Orphé; De Vleminck, Aline; Dierickx, Sigrid et al.
In: BMC Palliative Care, Vol. 20, No. 1, 193, 28.12.2021.

Research output: Contribution to journal › Article › peer-review

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): 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 - 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).

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 - cancer

KW - Dyadic

KW - Family caregiver

KW - Psychoeducational intervention

KW - Randomized clinical trial

U2 - 10.1186/s12904-021-00895-z

DO - 10.1186/s12904-021-00895-z

M3 - Article

C2 - 34963453

SN - 1472-684X

VL - 20

JO - BMC Palliative Care

JF - BMC Palliative Care

IS - 1

M1 - 193

ER -

Matthys O, De Vleminck A, Dierickx S, Deliens L, Van Goethem V, Lapeire L et al. 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. 2021 Dec 28;20(1):193. doi: 10.1186/s12904-021-00895-z