PROADAPT-ovary/EWOC-2

Last updated: December 20, 2024
Sponsor: Hospices Civils de Lyon
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ovarian Cancer

Pelvic Cancer

Ovarian Cysts

Treatment

PROADAPT program

Clinical Study ID

NCT04284969
69HCL18_0359
  • Ages > 70
  • Female

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Woman ≥70 year old OR Woman ≥60 years with significant comorbid condition (modifiedCharlson index≥3) or disability (ADL score<6/6);

  • Histologically or cytologically proven FIGO (International Federation of Gynecologyand Obstetrics) stage III to IV epithelial ovarian cancer or peritoneal primary orfallopian tube. A cytological proof is accepted if associated with a ratio ofCA125/CEA >25 and a radiological pelvic mass.

  • Patient oriented towards a complex medical procedure defined by pelvic surgerypreceded 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

Exclusion Criteria:

  • Any other progressive malignant tumor interfering with the patient's prognosis.

  • Patient whose validated therapeutic management does not include cytoreductivesurgery.

  • 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 orpsychological reasons.

  • Patient placed under guardianship or curatorship.

  • Patient deprived of liberty.

  • Concurrent participation in another interventional drug trial.

  • Patient already included in this study

Study Design

Total Participants: 292
Treatment Group(s): 1
Primary Treatment: PROADAPT program
Phase:
Study Start date:
June 03, 2021
Estimated Completion Date:
March 03, 2027

Study 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.

Connect with a study center

  • Chu Bordeaux Pellegrin

    Bordeaux, 33000
    France

    Completed

  • CH Métropole Savoie

    Chambery, 73000
    France

    Active - Recruiting

  • Centre Georges François Leclerc

    Dijon, 21079
    France

    Active - Recruiting

  • Hôpital Croix Rousse

    Lyon, 69004
    France

    Active - Recruiting

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

    Pierre-Bénite, 69495
    France

    Active - Recruiting

  • Centre hospitalier Annecy Genevois

    Pringy, 74374
    France

    Active - Recruiting

  • CHU Nord Saint Etienne - Service oncologie médicale

    Saint-Priest-en-Jarez, 42270
    France

    Active - Recruiting

  • CHU de St Etienne - Service gynécologie

    Saint-Priest-en-Jarez, 42270
    France

    Active - Recruiting

  • Institut Gustave Roussy

    Villejuif, 94805
    France

    Active - Recruiting

  • Médipôle Hôpital Mutualiste

    Villeurbanne, 69616
    France

    Active - Recruiting

  • Villeurbanne Médipole MHP

    Villeurbanne, 69616
    France

    Active - Recruiting

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