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)

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Chu Bordeaux Pellegrin
COMPLETED
Bordeaux
CH Métropole Savoie
RECRUITING
Chambéry
Centre Georges François Leclerc
RECRUITING
Dijon
Hôpital Croix Rousse
RECRUITING
Lyon
Service de Gériatrie, Centre Hospitalier Lyon Sud, 165 chemin du Grand Revoyet
RECRUITING
Pierre-bénite
Centre hospitalier Annecy Genevois
RECRUITING
Pringy
CHU de St Etienne - Service gynécologie
RECRUITING
Saint-priest-en-jarez
CHU Nord Saint Etienne - Service oncologie médicale
RECRUITING
Saint-priest-en-jarez
Institut Gustave Roussy
RECRUITING
Villejuif
Médipôle Hôpital Mutualiste
RECRUITING
Villeurbanne
Villeurbanne Médipole MHP
RECRUITING
Villeurbanne
Contact Information
Primary
Claire FALANDRY, PR
claire.falandry@chu-lyon.fr
4.78.86.32.87
Backup
Noual BAKRIN, MD
naoual.bakrin@chu-lyon.fr
Time Frame
Start Date: 2021-06-03
Estimated Completion Date: 2029-03-03
Participants
Target number of participants: 292
Treatments
No_intervention: Control arm
Patients treated according current practice of the inclusion center. If interventions are implemented locally (geriatric assessment, nutrition, physical activity) they may be proposed to the patient.
Experimental: Intervention arm : PROADAPT program
Patients benefiting from the PROADAPT (interventional arm) program.
Related Therapeutic Areas
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov