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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

268

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 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 Leon Berard
        • 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:
          • Jerome 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

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
Intervention / Treatment
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

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

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

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)

June 7, 2024

Primary Completion (Estimated)

September 7, 2027

Study Completion (Estimated)

June 7, 2028

Study Registration Dates

First Submitted

August 12, 2024

First Submitted That Met QC Criteria

August 12, 2024

First Posted (Actual)

August 14, 2024

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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