Using intervention mapping to facilitate and sustain return-to work after breast cancer: protocol for the FASTRACS multicentre randomized controlled trial.
Breast neoplasms
Cancer survivors
General practitioner
Intervention mapping
Intervention studies
Occupational health physician
Return to work
Self-efficacy
Theory-driven evaluation
Work disability prevention
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
05 Sep 2024
05 Sep 2024
Historique:
received:
14
02
2024
accepted:
12
08
2024
medline:
6
9
2024
pubmed:
6
9
2024
entrez:
5
9
2024
Statut:
epublish
Résumé
Women with breast cancer face many barriers to return to work (RTW) after their cancer. The main objective of the FASTRACS-RCT is to evaluate the impact of the FASTRACS (Facilitate and Sustain Return to Work after Breast Cancer) intervention on the sustainable RTW of breast cancer patients, 12 months after the end of active treatment. FASTRACS-RCT is a prospective, national, multicentre, randomized, controlled and open-label study. A total of 420 patients with early breast cancer scheduled for surgery and (neo)adjuvant chemotherapy, will be randomly assigned (1:1 ratio) to: (i) the intervention arm comprising four steps over 6 months : Handing over the intervention tools; transitional medical consultation with the general practitioner (GP); pre-RTW visit with the company's occupational physician (OP); catch-up visit with a hospital-based RTW expert (if sick leave > 10 months) (ii) the control arm to receive usual care. The design of the FASTRACS intervention was informed by intervention mapping for complex interventions in health promotion planning, and involved patients and representatives of relevant stakeholders. Specific tools were developed to bridge the gap between the hospital, the GP, the OP and the workplace: a toolkit for breast cancer patients comprising a theory-based guide; specific checklists for the GP and the OP, respectively; and a theory-based guide for workplace actors (employer, manager, colleagues). The primary endpoint will associate sustainable RTW (full-time or part-time work at 50% or more of working time, for at least 28 consecutive days) and days off work. It will be assessed at 4, 8 and 12 months after the end of active oncological treatment. Secondary endpoints will include quality of life, anxiety, depression, RTW self-efficacy, physical activity, social support, job accommodations, work productivity, job status, and the usefulness and acceptability of the intervention's tools. FASTRACS-RCT will be supplemented by a realist evaluation approach aimed at understanding the influence of context in activating the intervention's mechanisms and effects. If the expected impact of the intervention is confirmed, the intervention will be adapted and scaled-up for other cancers and chronic diseases to better integrate healthcare and work disability prevention. NCT04846972 ; April 15, 2021.
Sections du résumé
BACKGROUND
BACKGROUND
Women with breast cancer face many barriers to return to work (RTW) after their cancer. The main objective of the FASTRACS-RCT is to evaluate the impact of the FASTRACS (Facilitate and Sustain Return to Work after Breast Cancer) intervention on the sustainable RTW of breast cancer patients, 12 months after the end of active treatment.
METHODS
METHODS
FASTRACS-RCT is a prospective, national, multicentre, randomized, controlled and open-label study. A total of 420 patients with early breast cancer scheduled for surgery and (neo)adjuvant chemotherapy, will be randomly assigned (1:1 ratio) to: (i) the intervention arm comprising four steps over 6 months : Handing over the intervention tools; transitional medical consultation with the general practitioner (GP); pre-RTW visit with the company's occupational physician (OP); catch-up visit with a hospital-based RTW expert (if sick leave > 10 months) (ii) the control arm to receive usual care. The design of the FASTRACS intervention was informed by intervention mapping for complex interventions in health promotion planning, and involved patients and representatives of relevant stakeholders. Specific tools were developed to bridge the gap between the hospital, the GP, the OP and the workplace: a toolkit for breast cancer patients comprising a theory-based guide; specific checklists for the GP and the OP, respectively; and a theory-based guide for workplace actors (employer, manager, colleagues). The primary endpoint will associate sustainable RTW (full-time or part-time work at 50% or more of working time, for at least 28 consecutive days) and days off work. It will be assessed at 4, 8 and 12 months after the end of active oncological treatment. Secondary endpoints will include quality of life, anxiety, depression, RTW self-efficacy, physical activity, social support, job accommodations, work productivity, job status, and the usefulness and acceptability of the intervention's tools.
DISCUSSION
CONCLUSIONS
FASTRACS-RCT will be supplemented by a realist evaluation approach aimed at understanding the influence of context in activating the intervention's mechanisms and effects. If the expected impact of the intervention is confirmed, the intervention will be adapted and scaled-up for other cancers and chronic diseases to better integrate healthcare and work disability prevention.
TRIAL REGISTRATION
BACKGROUND
NCT04846972 ; April 15, 2021.
Identifiants
pubmed: 39237867
doi: 10.1186/s12885-024-12796-4
pii: 10.1186/s12885-024-12796-4
doi:
Banques de données
ClinicalTrials.gov
['NCT04846972']
Types de publication
Journal Article
Randomized Controlled Trial
Multicenter Study
Clinical Trial Protocol
Langues
eng
Sous-ensembles de citation
IM
Pagination
1107Subventions
Organisme : Institut National Du Cancer
ID : INCa Amorçage, RISP no 2016-003
Organisme : Cancéropôle Auvergne Rhône Alpes (CLARA)
ID : AAP ONCOSTARTER 2016
Organisme : Métropole du Grand Lyon
ID : Délibération 2016-1445 projets structurants 2016 2017
Organisme : Direction Régionale de l'économie, de l'emploi, du travail, et des solidarités (DREETS) Auvergne Rhône Alpes
ID : 2017-2018
Organisme : Institut National du Cancer
ID : INCa, RISP no 2018-025
Organisme : Association nationale de GEstion du Fonds pour l'Insertion Professionnelle des personnes Handicapées (Agefiph) et Direction Régionale des Entreprises, de la Concurrence, de la Consommation, du Travail et de l'Emploi (DIRECCTE, nouvellement DREETS )
ID : Appel à initiatives 2020
Informations de copyright
© 2024. The Author(s).
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