Actively Recruiting
PROADAPT-ovary/EWOC-2
Led by Hospices Civils de Lyon · Updated on 2025-12-04
292
Participants Needed
11
Research Sites
404 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
PROADAPT-ovary/EWOC-2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Woman aged 70 years or older, or woman 60 years or older with significant comorbidity (modified Charlson index 63) or disability (ADL score <6/6)
- Histologically or cytologically confirmed FIGO stage III to IV epithelial ovarian cancer, peritoneal primary, or fallopian tube cancer
- Directed to complex pelvic surgery with or without prior antineoplastic treatment (neoadjuvant chemotherapy)
- Therapeutic decision validated by a multidisciplinary consultation meeting
- Life expectancy greater than 3 months
- Provided written informed consent
- Covered by a health system where applicable
You will not qualify if you...
- Presence of any other progressive malignant tumor impacting prognosis
- Therapeutic management not including cytoreductive surgery
- Unable to be regularly followed up due to geographic, family, social, or psychological reasons
- Unable to understand questionnaires
- Unable to adhere to test procedures for geographic, social, or psychological reasons
- Under guardianship or curatorship
- Deprived of liberty
- Participation in another interventional drug trial
- Already included in this study
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Chu Bordeaux Pellegrin
Bordeaux, France, 33000
Completed
2
CH Métropole Savoie
Chambéry, France, 73000
Actively Recruiting
3
Centre Georges François Leclerc
Dijon, France, 21079
Actively Recruiting
4
Hôpital Croix Rousse
Lyon, France, 69004
Actively Recruiting
5
Service de Gériatrie, Centre Hospitalier Lyon Sud, 165 chemin du Grand Revoyet
Pierre-Bénite, France, 69495
Actively Recruiting
6
Centre hospitalier Annecy Genevois
Pringy, France, 74374
Actively Recruiting
7
CHU de St Etienne - Service gynécologie
Saint-Priest-en-Jarez, France, 42270
Actively Recruiting
8
CHU Nord Saint Etienne - Service oncologie médicale
Saint-Priest-en-Jarez, France, 42270
Actively Recruiting
9
Institut Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
10
Médipôle Hôpital Mutualiste
Villeurbanne, France, 69616
Actively Recruiting
11
Villeurbanne Médipole MHP
Villeurbanne, France, 69616
Actively Recruiting
Research Team
C
Claire FALANDRY, PR
CONTACT
N
Noual BAKRIN, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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