RecruitingNot ApplicableNCT04284969

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)


Sponsor

Hospices Civils de Lyon

Enrollment

292 participants

Start Date

Jun 3, 2021

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is designed for older or frail women with advanced ovarian cancer who may not be able to tolerate standard aggressive treatment. It tests different treatment strategies to find what works best for this group, including surgery and chemotherapy options tailored to each patient's health status. **You may be eligible if...** - You are a woman aged 70 or older, OR aged 60 or older with significant health problems or disability - You have been diagnosed with stage III–IV ovarian, peritoneal, or fallopian tube cancer confirmed by biopsy or cytology - Your doctor believes you need a complex treatment approach **You may NOT be eligible if...** - You are younger than 60 (unless you have significant disability or health issues) - Your cancer is not at an advanced stage - You are unable to tolerate the planned treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALPROADAPT program

* A pre-intervention activity by telephone follow-ups every week for 12 weeks and then every month. * Pre-operative physical training including strength, endurance and breathing exercises. * A nutrition activity. * An activity to educate patients (on nutrition, exercise). * The implementation of standardised intervention procedures, established in agreement with the surgeons' representatives. * A pharmaceutical drug conciliation activity: optimization of the patient's different treatments with pharmaceutical expertise. * A transition activity from the hospital to the home, and a telephone follow-up up to 12 weeks after the surgery.


Locations(11)

Chu Bordeaux Pellegrin

Bordeaux, France

CH Métropole Savoie

Chambéry, France

Centre Georges François Leclerc

Dijon, France

Hôpital Croix Rousse

Lyon, France

Service de Gériatrie, Centre Hospitalier Lyon Sud, 165 chemin du Grand Revoyet

Pierre-Bénite, France

Centre hospitalier Annecy Genevois

Pringy, France

CHU de St Etienne - Service gynécologie

Saint-Priest-en-Jarez, France

CHU Nord Saint Etienne - Service oncologie médicale

Saint-Priest-en-Jarez, France

Institut Gustave Roussy

Villejuif, France

Médipôle Hôpital Mutualiste

Villeurbanne, France

Villeurbanne Médipole MHP

Villeurbanne, France

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NCT04284969


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