Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT04284969
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2020-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PROADAPT-ovary/EWOC-2
Sponsor:
Hospices Civils de Lyon
Organization:
Study Overview
Official Title:
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)
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
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:
With the conjunction of increased life expectancy and the increasing incidence of cancer with aging, older patient represent an increasing proportion of cancer patients. Increasing age is also associated with increased risk of co-morbidities as well as a decline of functional reserve of multiple organ systems, eventually leading in the context of the disease-and/or the treatment-related stress to functional deconditioning or organ failure.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: