PROADAPT-ovary/EWOC-2

April 20, 2023 updated by: Hospices Civils de Lyon

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)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

292

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Pierre-Bénite, France, 69495
        • Recruiting
        • Service de Gériatrie, Centre Hospitalier Lyon Sud, 165 chemin du Grand Revoyet
        • Contact:
        • Contact:
        • Principal Investigator:
          • Claire FALANDRY, PR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

68 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: Intervention arm : PROADAPT program
Patients benefiting from the PROADAPT (interventional arm) program.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Superiority for post-treatment complication grade≥3
Time Frame: At 30 days post-treatment
• Superiority for post-treatment complication grade≥3 according the NCI-CTC-v4 (Common Terminology Criteria : CTC) at 30 days
At 30 days post-treatment
Superiority of HRQOL on the dimensions
Time Frame: At 3 months
Superiority of HRQOL on the dimensions: Mobility, burden of illness, emotional and physical functioning, fatigue, at 3 months
At 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative morbidity according Clavien-Dindo classification at 30 and 90 days
Time Frame: At 30 and 90 days

Clavien Dindo classification consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population observed or the of the focus of a study.

Complications that have the potential for long-lasting disability after patient's discharge (e.g.: paralysis of a voice cord after thyroid surgery) are highlighted in the present classification by a suffix ("d" for disability). This suffix indicates that a follow-up is required to comprehensively evaluate the outcome and related long-term quality of life.
At 30 and 90 days
Therapeutic strategy (treatment plan completion rate)
Time Frame: 2 years
A complete therapeutic strategy consists of a complete cytoreductive surgery (CC0) 6 courses of chemotherapy at least in total, either in neo-adjuvant or in adjuvant setting, with at least 2 courses after surgery.
2 years
Progression free survival
Time Frame: 2 years
Progression-free survival (PFS) is defined as the time from random assignment to disease progression or death from any cause.
2 years
Overall survival
Time Frame: 2 years
Overall survival is defined as the time from randomization to death from any cause
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2021

Primary Completion (Anticipated)

March 6, 2024

Study Completion (Anticipated)

March 3, 2026

Study Registration Dates

First Submitted

February 24, 2020

First Submitted That Met QC Criteria

February 24, 2020

First Posted (Actual)

February 26, 2020

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 20, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL18_0359

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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