Informations générales (source: ClinicalTrials.gov)
Prehabilitation & Rehabilitation in Oncogeriatrics: Adaptation to Deconditioning Risk and Accompaniment of Patients' Trajectories-ovary/Elderly Women with Ovarian Cancer-2, a GINECO Multicenter Randomized Study (PROADAPT-ovary/EWOC-2)
Interventional
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
juin 2021
mars 2027
05 avril 2025
PROADAPT is a standardized geriatric intervention that is currently being co-constructed
during an exploratory phase on a multi-professional and multi-disciplinary basis after a
systematic analysis of published data (Figure).
It consists in: 1) before surgery: a prehabilitation of the patients including a
nutritional, physical and educational preparation; 2) during the hospitalization for
surgery: an optimisation of their treatments through a pharmaceutical conciliation,
educational interventions, standardization of surgical procedures and enhanced
rehabilitation after surgery; 3) bridging and post-discharge interventions for
hospital-to-home transition.
This intervention is based on a logic change model, constructed with literature data and
validated by an expert group through a DELPHI method : the rehabilitation model.
This intervention was designed to be implemented pragmatically in the centers according
local habits and is currently being evaluated in several distinct hospital contexts under
the name of "PROADAPT pilot study" in different tumor contexts thanks to a grant from the
Regional Health Agency of Rhône-Alpes Auvergne region.
PROADAPT intervention is planned to be evaluated in 4 tumor models inducing complex
medico-surgical procedures considered at high risk of geriatric deconditioning. They have
the same primary objectives in order to be evaluated into a meta-analysis. Results will
be used to test the validity of the rehabilitation model. Therefore, it is a study
reaching the goal of the population health intervention research.
The purpose of the PROADAPT-ovary/EWOC-2 study is to evaluate the impact of PROADAPT on
patient's post-surgical outcomes in patients ≥ 70 years old with an advanced ovarian
cancer (AOC).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Maxime FRELAUT | 16/04/2024 07:02:48 | Contacter | ||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Service de Gériatrie, Centre Hospitalier Lyon Sud, 165 chemin du Grand Revoyet - 69495 - Pierre-Bénite - France | Claire FALANDRY, PR | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Georges François Leclerc - 21079 - Dijon - France | Leïla BENGRINE-LEFEVRE | Contact (sur clinicalTrials) | |||
| Centre hospitalier Annecy Genevois - 74374 - Pringy - France | Laetitia STEFANI | Contact (sur clinicalTrials) | |||
| CH Métropole Savoie - 73000 - Chambery - France | Nathalie MARQUES | Contact (sur clinicalTrials) | |||
| Chu Bordeaux Pellegrin - 33000 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| CHU de St Etienne - Service gynécologie - 42270 - Saint-Priest-en-Jarez - France | CHAULEUR, Céline | Contact (sur clinicalTrials) | |||
| CHU Nord Saint Etienne - Service oncologie médicale - 42270 - Saint-Priest-en-Jarez - France | Contact (sur clinicalTrials) | ||||
| Hôpital Croix Rousse - 69004 - Lyon - France | Emilie NGUYEN-BA | Contact (sur clinicalTrials) | |||
| Médipôle Hôpital Mutualiste - 69616 - Villeurbanne - France | Marie BEGUINOT | Contact (sur clinicalTrials) | |||
| Villeurbanne Médipole MHP - 69616 - Villeurbanne - France | Jean-Sébastien KRAUTH | Contact (sur clinicalTrials) | |||
Critères
Femme
Inclusion Criteria:
- Woman ≥70 year old OR Woman ≥60 years with significant comorbid condition (modified
Charlson index≥3) or disability (ADL score<6/6);
- Histologically or cytologically proven FIGO (International Federation of Gynecology
and Obstetrics) stage III to IV epithelial ovarian cancer or peritoneal primary or
fallopian tube. A cytological proof is accepted if associated with a ratio of
CA125/CEA >25 and a radiological pelvic mass.
- Patient oriented towards a complex medical procedure defined by pelvic surgery
preceded or not by antineoplastic treatment (neoadjuvant chemotherapy).
- Therapeutic decision validated in a multidisciplinary consultation meeting
- Life expectancy > 3 months.
- Written informed consent obtained.
- Covered by a Health System where applicable.
- Woman ≥70 year old OR Woman ≥60 years with significant comorbid condition (modified
Charlson index≥3) or disability (ADL score<6/6);
- Histologically or cytologically proven FIGO (International Federation of Gynecology
and Obstetrics) stage III to IV epithelial ovarian cancer or peritoneal primary or
fallopian tube. A cytological proof is accepted if associated with a ratio of
CA125/CEA >25 and a radiological pelvic mass.
- Patient oriented towards a complex medical procedure defined by pelvic surgery
preceded or not by antineoplastic treatment (neoadjuvant chemotherapy).
- Therapeutic decision validated in a multidisciplinary consultation meeting
- Life expectancy > 3 months.
- Written informed consent obtained.
- Covered by a Health System where applicable.
- Any other progressive malignant tumor interfering with the patient's prognosis.
- Patient whose validated therapeutic management does not include cytoreductive
surgery.
- Patient unable to be regularly followed up for any reason (geographic, family,
social, psychological).
- Patient unable to understand the questionnaires.
- Patient unable to follow and adhere to test procedures for geographic, social or
psychological reasons.
- Patient placed under guardianship or curatorship.
- Patient deprived of liberty.
- Concurrent participation in another interventional drug trial.
- Patient already included in this study