Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
292 participants
INTERVENTIONAL
2021-06-03
2027-03-03
Brief Summary
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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).
Detailed Description
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Surgery or complex medico-surgical procedures can be considered as one proof-of principle of such risks, since major cancer surgery the older population is at higher risk of morbi-mortality and unplanned hospitalization for geriatric events1.
In order to reduce complications after surgery, prehabilitation has often been considered, and 71% of the surgeons would accept a 4 weeks delay before surgery to improve patients' outcomes if shown to be beneficial2. However, the actual level of evidence depends on the interventions: high for pre-operative nutrition3, but low for physical exercise, due to heterogeneous programs with often bad adherence4. In addition, geriatric validated interventions, in order to prevent iatrogenic event, may be added in a multi-interventional model of intervention.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Control arm
Patients treated according current practice of the inclusion center. If interventions are implemented locally (geriatric assessment, nutrition, physical activity) they may be proposed to the patient.
No interventions assigned to this group
Intervention arm : PROADAPT program
Patients benefiting from the PROADAPT (interventional arm) program.
PROADAPT 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.
Interventions
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PROADAPT 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
70 Years
FEMALE
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Nathalie MARQUES
Role: primary
Leïla BENGRINE-LEFEVRE
Role: primary
Emilie NGUYEN-BA
Role: primary
Claire FALANDRY, PR
Role: primary
Noual BAKRIN, MD
Role: backup
Claire FALANDRY, PR
Role: backup
Laetitia STEFANI
Role: primary
CHAULEUR, Céline
Role: primary
FRELAUT, Maxime
Role: primary
Marie BEGUINOT
Role: primary
Jean-Sébastien KRAUTH
Role: primary
Other Identifiers
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69HCL18_0359
Identifier Type: -
Identifier Source: org_study_id