Actively Recruiting

Phase Not Applicable
Age: 70Years +
FEMALE
NCT04284969

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

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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

Age: 70Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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