Effectiveness of a nurse-delivered (FOCUS plus ) 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

被引：11

作者：

Matthys, Orphe ^{[1
,2
]}

De Vleminck, Aline ^{[1
,2
]}

Dierickx, Sigrid ^{[1
,2
]}

Deliens, Luc ^{[1
,2
]}

Van Goethem, Vincent ^{[1
,2
]}

Lapeire, Lore ^{[3
]}

Groenvold, Mogens ^{[4
,5
]}

Lund, Line ^{[4
,5
]}

Arnfeldt, Caroline Moeller ^{[4
,5
]}

Sengeloev, Lisa ^{[6
]}

Pappot, Helle ^{[7
]}

Johnsen, Anna Thit ^{[8
]}

Guerin, Suzanne ^{[9
]}

Larkin, Philip J. ^{[10
,11
]}

Jordan, Catherine ^{[9
]}

Connolly, Michael ^{[12
]}

D'Alton, Paul ^{[9
]}

Costantini, Massimo ^{[13
]}

Di Leo, Silvia ^{[14
]}

Guberti, Monica ^{[15
]}

Turola, Elena ^{[13
]}

van der Heide, Agnes ^{[16
]}

Witkamp, Erika ^{[16
]}

Rietjens, Judith ^{[16
]}

van der Wel, Maaike ^{[16
]}

Brazil, Kevin ^{[17
]}

Prue, Gillian ^{[17
]}

Reid, Joanne ^{[17
]}

Scott, David ^{[17
]}

Bristowe, Katherine ^{[18
]}

Harding, Richard ^{[18
]}

Normand, Charles ^{[19
,20
]}

May, Peter ^{[19
,21
]}

Cronin, Catherine ^{[19
]}

Northouse, Laurel ^{[22
]}

Hudson, Peter ^{[23
,24
]}

Cohen, Joachim ^{[1
,2
]}

机构：

[1] Vrije Univ Brussel VUB, End Of Life Care Res Grp, Brussels, Belgium

[2] Ghent Univ Brussels, Brussels, Belgium

[3] Ghent Univ Hosp, Dept Med Oncol, Ghent, Belgium

[4] Univ Copenhagen, Dept Publ Hlth, Copenhagen, Denmark

[5] Bispebjerg & Frederiksberg Hosp, Palliat Care Res Unit, Copenhagen, Denmark

[6] Herlev Gentofte Univ Hosp, Dept Oncol, Herlev, Denmark

[7] Univ Copenhagen, Rigshosp, Dept Oncol, Copenhagen, Denmark

[8] Univ Southern Denmark, Odense, Denmark

[9] Univ Coll Dublin, UCD Sch Psychol, Belfield, Ireland

[10] Lausanne Univ Hosp, Palliat & Support Care Serv, Chair Palliat Care Nursing, Lausanne, Switzerland

[11] Univ Lausanne, Lausanne, Switzerland

[12] Univ Coll Dublin, Sch Nursing Midwifery & Hlth Syst, Dublin, Ireland

[13] Azienda USL IRCCS Reggio Emilia, Sci Directorate, Reggio Emilia, Italy

[14] Azienda USL IRCCS Reggio Emilia, Psychooncol Unit, Reggio Emilia, Italy

[15] Azienda USL IRCCS, Nursing & Hlth Care Profess Directorate, Reggio Emilia, Italy

[16] Univ Med Ctr Rotterdam, Dept Publ Hlth, Erasmus MC, Rotterdam, Netherlands

[17] Queens Univ Belfast, Sch Nursing & Midwifery, 97 Lisburn Rd, Belfast BT9 7BL, Antrim, North Ireland

[18] Kings Coll London, Florence Nightingale Fac Nursing Midwifery & Pall, Cicely Saunders Inst, London, England

[19] Trinity Coll Dublin, Ctr Hlth Policy & Management, Dublin, Ireland

[20] Cicely Saunders Inst Palliat Care Policy & Rehabi, London, England

[21] Irish Longitudinal Study Ageing, Dublin, Ireland

[22] Univ Michigan, Sch Nursing, Ann Arbor, MI 48109 USA

[23] St Vincents Hosp, Ctr Palliat Care, Melbourne, Vic, Australia

[24] Vrije Univ Brussels VUB, Brussels, Belgium

来源：

BMC PALLIATIVE CARE | 2021年 / 20卷 / 01期

基金：

欧盟地平线“2020”;

关键词：

Psychoeducational intervention; Dyadic; cancer; Family caregiver; Randomized clinical trial; QUALITY-OF-LIFE; ITEM BANK; INSTRUMENT; VERSION; VALIDATION; WOMEN;

D O I：

10.1186/s12904-021-00895-z

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

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 faceto-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.

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