Impact of a Multidisciplinary Assessment in Day Hospitalization Versus Standard Care on the Deployment of Supportive Oncology Care Recommended by the Personalized Post-cancer Plan in Patients at the End of Initial Treatment for Gynecological Ovarian and Endometrial Cancer Endometrial Cancer (AFTERGYN2)

January 7, 2026 updated by: Centre Francois Baclesse
This project proposes a structuring of supportive oncology care for the recovery phase after gynecological cancer (ovarian/trope/peritoneum or endometrium). Patients will be divided into three groups based on the identification of oncological support care needs. Patients with supportive oncology care needs will be randomized into two groups: the experimental group, receiving a personalized post-cancer plan with a multidisciplinary assessment of supportive oncology care needs in a day hospital and coordinated follow-up by the referring study nurse, and the control group, receiving a personalized post-cancer plan without a day hospital. Randomization will be stratified according to tumor location (ovary vs. endometrium), use of supportive oncology care during treatment, and treatment center. Patients with no need for supportive oncology care will be followed in an observational cohort. The main objective is to identify and manage the supportive oncology care needs of patients in remission from endometrial or ovarian cancer to improve their quality of life and post-treatment follow-up. A medico-economic analysis will be performed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
268

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Besançon, France
        • Recruiting
        • CHU, Besançon
        • Contact:
          • Laura MANSI, MD
        • Principal Investigator:
          • Laura Mansi, MD
      • Caen, France
        • Recruiting
        • François Baclesse
        • Contact:
          • Florence JOLY, Prof
      • Clermont-Ferrand, France
        • Not yet recruiting
        • Centre Jean Perrin
        • Principal Investigator:
          • Elsa KALBACHER, MD
        • Contact:
      • Lyon, France
        • Recruiting
        • Centre Léon Bérard
        • Contact:
          • Olivia LE SAUX, MD
        • Principal Investigator:
          • Olivia LE SAUX, MD
      • Paris, France
        • Not yet recruiting
        • Institut Curie
        • Contact:
          • Diana BELLO ROUFAI, MD
        • Principal Investigator:
          • Diana BELLO ROUFAI, MD
      • Paris, France
        • Not yet recruiting
        • Hôpital Cochin
        • Contact:
          • Anne Catherine PIKETTY, MD
        • Principal Investigator:
          • Anne Catherine PIKETTY, MD
      • Paris, France
        • Not yet recruiting
        • Hôpital Européen George Pompidou
        • Contact:
          • Claire GERVAIS, MD
      • Paris, France
        • Recruiting
        • Hopital Diaconesses Croix Saint-Simon
        • Contact:
          • Frederic SELLES, MD
        • Principal Investigator:
          • Frederic SELLES, MD
      • Plérin, France
        • Not yet recruiting
        • Hôpital Privé Des Côtes d'Armor
        • Contact:
          • Jérôme MARTIN-BABAU, MD
        • Principal Investigator:
          • Jérôme MARTIN-BABAU, MD
      • Saint-Cloud, France
        • Recruiting
        • Institut Curie, St Cloud
        • Contact:
          • Diana BELLO ROUFAI, MD
        • Principal Investigator:
          • Diana BELLO ROUFAI, MD
      • Saint-Etienne, France
        • Not yet recruiting
        • CHU, Saint Etienne
        • Contact:
          • Aurélie BENETON, MD
        • Principal Investigator:
          • Aurélie BENETON, MD
      • Strasbourg, France
        • Recruiting
        • CHU
        • Principal Investigator:
          • Philippe TRENSZ, MD
        • Contact:
          • Virginie LEROY, MD
      • Villejuif, France
        • Recruiting
        • Gustave Roussy
        • Principal Investigator:
          • Patricia PAUTIER, MD
        • Contact:
          • Patricia PAUTIER, MD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient > 18 years
  • Patients in remission from first-line treatment of endometrial or ovarian/tumor/peritoneal cancer.
  • Patient who has completed her initial treatment; patients on maintenance therapy are eligible.
  • Fluency in French
  • Patient with access to a telephone line
  • Patient affiliated to a social security scheme
  • Signature of informed consent prior to any specific study procedure

Exclusion Criteria:

  • Any associated medical or psychiatric condition that could compromise the patient's ability to participate in the study
  • Patient with locoregional or metastatic recurrence
  • Patient deprived of liberty, under guardianship or curatorship
  • Simultaneous participation in a therapeutic clinical trial

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
Delivery of personalized post-cancer plan with multidisciplinary assessment of oncology support care needs in a day hospital
Other: Multidisciplinary assessment
Delivery of a personalized post-cancer plan with multidisciplinary assessment of oncology support care needs in a day hospital
Active Comparator: Control group
Delivery of a personalized post-cancer plan without a day hospital
Other: Standard assesment
Delivery of a personalized post-cancer plan without a day hospital
Other: Cohort
Follow-up as part of an observational cohort
Other: Observational cohort
Patients with no cancer sequelae, no adverse effects and no need for oncological support care will not be randomized, but will be followed as part of an observational cohort

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Compare the proportion of patients for whom the supportive oncology care recommended in the personalized post-cancer plan has been implemented.
Time Frame: 6 months after delivery of personalized post-cancer plan, i.e. about 8 months after inclusion
The primary criterion is the proportion of patients who have implemented at least one of the supportive oncology treatments recommended in the personalized post-cancer plan within 6 months of receiving the personalized post-cancer plan.
6 months after delivery of personalized post-cancer plan, i.e. about 8 months after inclusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison, 12 months after delivery of the personalized post-cancer plan, of the impact of the intervention on the improvement of side effects and/or sequelae identified at the end of the initial treatments.
Time Frame: 12 months after delivery of personalized post-cancer plan, i.e. about 14 months after inclusion
Proportion of patients presenting, at 12 months, an improvement (reduction in grade according to CTCAE v5.0 criteria) in at least one of the side effects and/or sequelae identified at the end of the initial treatments according to the INCa identification grids (1st and 2nd levels).
12 months after delivery of personalized post-cancer plan, i.e. about 14 months after inclusion

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Francois Baclesse

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 7, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 7, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 7, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-A02554-41

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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