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Gynecologic CancerAFTERGYN2NCT06553612

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

A study testing Multidisciplinary assessment, Standard assesment and Observational cohort in people with Gynecologic Cancer and Remission, run by Centre Francois Baclesse at 13 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Gynecologic Cancer, Remission
What is being tested?
Multidisciplinary assessment, Standard assesment and Observational cohort
Could I receive a placebo?
No, everyone receives an active treatment
How many people
268 participants
Where
13 sitesFrance
Study dates
7 Jun 2024to 7 Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Florence JOLY, Prof contact

02 31 45 50 50

f.joly@baclesse.unicancer.fr

13 sites in 1 country

France13 sites, 13 recruiting

  • CHU, Besançon

    Besançon

    Laura MANSI, MD

    Laura MANSI, MD

    Recruiting

  • François Baclesse

    Caen

    Florence JOLY, Prof

    Recruiting

  • Centre Jean Perrin

    Clermont-Ferrand

    Elsa KALBACHER, MD, 33473278080, elsa.kalbacher@clermont.unicancer.fr

    Elsa KALBACHER, MD

    Not yet recruiting

  • Centre Léon Bérard

    Lyon

    Olivia LE SAUX, MD

    Olivia LE SAUX, MD

    Recruiting

  • Hopital Diaconesses Croix Saint-Simon

    Paris

    Frederic SELLES, MD

    Frederic SELLES, MD

    Recruiting

  • Hopital Europeen George Pompidou

    Paris

    Claire GERVAIS, MD

    Not yet recruiting

  • Hôpital COCHIN

    Paris

    Anne Catherine PIKETTY, MD

    Anne Catherine PIKETTY, MD

    Not yet recruiting

  • Institut Curie

    Paris

    Diana BELLO ROUFAI, MD

    Diana BELLO ROUFAI, MD

    Not yet recruiting

  • Hopital privé des Côtes d'Armor

    Plérin

    Jerome MARTIN-BABAU, MD

    Jerome MARTIN-BABAU, MD

    Not yet recruiting

  • Institut Curie, St Cloud

    Saint-Cloud

    Diana BELLO ROUFAI, MD

    Diana BELLO ROUFAI, MD

    Recruiting

  • CHU, Saint Etienne

    Saint-Etienne

    Aurélie BENETON, MD

    Aurélie BENETON, MD

    Not yet recruiting

  • CHU

    Strasbourg

    Virginie LEROY, MD

    Philippe TRENSZ, MD

    Recruiting

  • Gustave Roussy

    Villejuif

    Patricia PAUTIER, MD

    Patricia PAUTIER, MD

    Recruiting

Other trials in France

About this study

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.

Being tested
Multidisciplinary assessment, Standard assesment, Observational cohort
Keywords
supportive oncology care, personalized post-cancer plan

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multidisciplinary assessmentOther

    Delivery of a personalized post-cancer plan with multidisciplinary assessment of oncology support care needs in a day hospital

  • Standard assesmentOther

    Delivery of a personalized post-cancer plan without a day hospital

  • Observational cohortOther

    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

Study groups in NCT06553612
Study groupRoleWhat they receive
Experimental groupExperimentalDelivery of personalized post-cancer plan with multidisciplinary assessment of oncology support care needs in a day hospital
Receives: Other: Multidisciplinary assessment
Control groupActive comparatorDelivery of a personalized post-cancer plan without a day hospital
Receives: Other: Standard assesment
CohortOtherFollow-up as part of an observational cohort
Receives: Other: Observational cohort

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare the proportion of patients for whom the supportive oncology care recommended in the personalized post-cancer plan has been implemented.

    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.

    Measured: 6 months after delivery of personalized post-cancer plan, i.e. about 8 months after inclusion

Secondary outcomes (1)

  1. 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.

    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).

    Measured: 12 months after delivery of personalized post-cancer plan, i.e. about 14 months after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2024
  2. Study start7 Jun 2024
  3. Primary completion7 Sep 2028 (estimated)
  4. Study completion7 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
268 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06553612
Sponsor's protocol ID
2023-A02554-41
Acronym
AFTERGYN2
Status last verified
Sep 2026
First submitted
12 Aug 2024
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Multidisciplinary assessment, Standard assesment and Observational cohort in people with Gynecologic Cancer and Remission, run by Centre Francois Baclesse at 13 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Florence JOLY, Prof (02 31 45 50 50, f.joly@baclesse.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06553612.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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