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PROADAPT-ovary/EWOC-2

RecruitingNAAges 70 Years - anyFemaleHospices Civils de Lyon
NCT04284969 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 i

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * Any other progressive malignant tumor interfering with the patient's prognosis. * Patient whose validated therapeutic management does not include cytoreductive surgery. * 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. * Concurrent participation in another interventional drug trial. * Patient already included in this study
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What it tests

  • PROADAPT program
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Where

11 sites
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

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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