Feasibility of a prehabilitation programme dedicated to older patients with cancer before complex medical-surgical procedures: the PROADAPT pilot study protocol.

Autor:	Roche M; Plateforme Transversale de Recherche de l'IC-HCL, Hospices Civils de Lyon, Lyon, France., Ravot C; Geriatrics Unit, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Lyon, France., Malapert A; Plateforme Transversale de Recherche de l'IC-HCL, Hospices Civils de Lyon, Lyon, France., Paget-Bailly S; Methodology and Quality of Life Unit in Oncology, University Hospital Centre Besancon, Besancon, France.; INSERM, EFS BFC, UMR1098, Interactions Hôte-Greffon-Tumeur/Ingénierie Cellulaire Et Génique, Université Bourgogne Franche-Comté, Besancon, France., Garandeau C; Direction à la Recherche Clinique et à l'Innovation, Hospices Civils de Lyon, Lyon, France., Pitiot V; Plateforme Transversale de Recherche de l'IC-HCL, Hospices Civils de Lyon, Lyon, France., Tomatis M; Geriatrics Unit, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Lyon, France., Riche B; Service de Biostatistique - Bioinformatique, Pôle Santé Publique, Hospices Civils de Lyon, Lyon, France.; Laboratoire de Biométrie et Biologie Évolutive CNRS UMR 5558, Équipe Biostatistiques Santé, Université de Lyon, Lyon, France., Galamand B; Geriatrics Unit, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Lyon, France., Granger M; Geriatrics Unit, Hospices Civils de Lyon, Lyon, France.; Centre Hospitalier de Chambery, Chambery, France., Barbavara C; Geriatrics Unit, Hospices Civils de Lyon, Lyon, France., Bourgeois C; Department of Medical Oncology, Centre Hospitalier Annecy Genevois, Pringy, France., Genest E; Geriatrics Unit, Hospices Civils de Lyon, Lyon, France., Stefani L; Department of Medical Oncology, Centre Hospitalier Annecy Genevois, Pringy, France., Haïne M; Pôle de gérontologie et Médecine de Réadaptation, Hôpital Nord-Ouest, Villefranche-sur-Saone, France., Castel-Kremer E; Geriatrics Unit, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France., Morel-Soldner I; Geriatrics Unit, Centre Hospitalier de la Croix Rousse, Hospices Civils de Lyon, Lyon, France., Collange V; Département anesthésie réanimation, Medipole Lyon-Villeurbanne, Villeurbanne, France., Le Saux O; Therapeutic targeting of the tumor cell and its immune microenvironment, Centre de Recherche en Cancerologie de Lyon, Lyon, France., Dayde D; Plateforme Transversale de Recherche de l'IC-HCL, Hospices Civils de Lyon, Lyon, France., Falandry C; Geriatrics Unit, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Lyon, France claire.falandry@chu-lyon.fr.; CarMeN Laboratory, Inserm U1060, INRA U1397, Université Claude Bernard Lyon 1, INSA Lyon, Charles Mérieux Medical School, Oullins, France.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2021 Apr 02; Vol. 11 (4), pp. e042960. Date of Electronic Publication: 2021 Apr 02.
DOI:	10.1136/bmjopen-2020-042960
Abstrakt:	Background: Ageing is associated with an increased prevalence of comorbidities and sarcopenia as well as a decline of functional reserve of multiple organ systems, which may lead, in the context of the disease-related and/or treatment-related stress, to functional deconditioning. The multicomponent 'Prehabilitation & Rehabilitation in Oncogeriatrics: Adaptation to Deconditioning risk and Accompaniment of Patients' Trajectories (PROADAPT)' intervention was developed multiprofessionally to implement prehabilitation in older patients with cancer. Methods: The PROADAPT pilot study is an interventional, non-comparative, prospective, multicentre study. It will include 122 patients oriented to complex medical-surgical curative procedures (major surgery or radiation therapy with or without chemotherapy). After informed consent, patients will undergo a comprehensive geriatric assessment and will be offered a prehabilitation kit that includes an advice booklet with personalised objectives and respiratory rehabilitation devices. Patients will then be called weekly and monitored for physical and respiratory rehabilitation, preoperative renutrition, motivational counselling and iatrogenic prevention. Six outpatient visits will be planned: at inclusion, a few days before the procedure and at 1, 3, 6 and 12 months after the end of the procedure. The main outcome of the study is the feasibility of the intervention, defined as the ability to perform at least one of the components of the programme. Clinical data collected will include patient-specific and cancer-specific characteristics. Ethics and Dissemination: The study protocol was approved by the Ile de France 8 ethics committee on 5 June 2018. The results of the primary and secondary objectives will be published in peer-reviewed journals. Trial Registration Number: NCT03659123. Pre-results of the trial. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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