NCT04284969Recruiting
PROADAPT-ovary/EWOC-2
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)
Source: ClinicalTrials.gov · Last updated 4 Dec 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 292 (estimated)
- First submitted
- 24 Feb 2020
- Start date
- 3 Jun 2021
- Primary completion date
- 3 Jun 2027
- Lead sponsor
- Hospices Civils de Lyon
- Diseases
- Ovarian cancer
- NCT number
- NCT04284969
What you commit to
- Study type: Interventional
- Planned participants: 292
- From 3 Jun 2021 to the primary completion date, 3 Jun 2027
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient whose validated therapeutic management does not include cytoreductive surgery.
- Concurrent participation in another interventional drug trial.
Other illness
- Any other progressive malignant tumor interfering with the patient's prognosis.
Other
- 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.
- Patient already included in this study
Who the study is looking for
- 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.
Age in the registry: 70 years to - · Sex: Female · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chu Bordeaux Pellegrin Coordinator of this site? Confirm its status | Bordeaux | France | Completed |
| CH Métropole-Savoie Coordinator of this site? Confirm its status | Chambéry | France | Recruiting |
| Centre Georges François Leclerc Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| Hôpital Croix Rousse Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Service de Gériatrie, Centre Hospitalier Lyon Sud, 165 chemin du Grand Revoyet Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| Centre Hospitalier Annecy Genevois Coordinator of this site? Confirm its status | Pringy | France | Recruiting |
| CHU Nord Saint Etienne - Service oncologie médicale Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Recruiting |
| CHU de St Etienne - Service gynécologie Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| Villeurbanne Médipole MHP Coordinator of this site? Confirm its status | Villeurbanne | France | Recruiting |
| Médipôle Hôpital Mutualiste Coordinator of this site? Confirm its status | Villeurbanne | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.