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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
- Source :
- 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 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, 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 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, BMC Palliative Care, BMC Palliative Care, 20(1):193. BioMed Central Ltd., Matthys, O, De Vleminck, A, Dierickx, S, Deliens, L, Van Goethem, V, Lapeire, L, Grønvold, M, Lund, L, Arnfeldt, C M, Sengeløv, 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 2021, ' 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 ', BMC Palliative Care, vol. 20, no. 1 . https://doi.org/10.1186/s12904-021-00895-z, BMC Palliative Care, Vol 20, Iss 1, Pp 1-18 (2021), BMC PALLIATIVE CARE
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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.
- Subjects :
- Dyadic
VALIDATION
Psychoeducational intervention
03 medical and health sciences
Study Protocol
0302 clinical medicine
SDG 3 - Good Health and Well-being
QUALITY-OF-LIFE
Neoplasms
Medicine and Health Sciences
Neoplasms/therapy
Humans
Multicenter Studies as Topic
cancer
030212 general & internal medicine
VERSION
Randomized Controlled Trials as Topic
Medicine(all)
Internet
INSTRUMENT
Public Health, Environmental and Occupational Health
Psychosocial Support Systems
WOMEN
RC952-1245
General Medicine
ITEM BANK
3. Good health
Special situations and conditions
Caregivers
030220 oncology & carcinogenesis
oncology
Quality of Life
Randomized clinical trial
Family caregiver
Subjects
Details
- Language :
- English
- ISSN :
- 1472684X
- Volume :
- 20
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- BMC Palliative Care
- Accession number :
- edsair.doi.dedup.....52f3ef46438271eada9e4141c006456c
- Full Text :
- https://doi.org/10.1186/s12904-021-00895-z