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

NCT ID: NCT06553612

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-07

Study Completion Date

2028-06-07

Brief Summary

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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.

Detailed Description

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Conditions

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Gynecologic Cancer Remission

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental group

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

Group Type EXPERIMENTAL

Multidisciplinary assessment

Intervention Type OTHER

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

Control group

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

Group Type ACTIVE_COMPARATOR

Standard assesment

Intervention Type OTHER

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

Cohort

Follow-up as part of an observational cohort

Group Type OTHER

Observational cohort

Intervention Type OTHER

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

Interventions

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Multidisciplinary assessment

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

Intervention Type OTHER

Standard assesment

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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Francois Baclesse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU, Besançon

Besançon, , France

Site Status RECRUITING

François Baclesse

Caen, , France

Site Status RECRUITING

Centre Jean Perrin

Clermont-Ferrand, , France

Site Status NOT_YET_RECRUITING

Centre Léon Bérard

Lyon, , France

Site Status RECRUITING

Hopital Diaconesses Croix Saint-Simon

Paris, , France

Site Status RECRUITING

Hopital Europeen George Pompidou

Paris, , France

Site Status NOT_YET_RECRUITING

Hôpital COCHIN

Paris, , France

Site Status NOT_YET_RECRUITING

Institut Curie

Paris, , France

Site Status NOT_YET_RECRUITING

Hopital privé des Côtes d'Armor

Plérin, , France

Site Status NOT_YET_RECRUITING

Institut Curie, St Cloud

Saint-Cloud, , France

Site Status RECRUITING

CHU, Saint Etienne

Saint-Etienne, , France

Site Status NOT_YET_RECRUITING

CHU

Strasbourg, , France

Site Status RECRUITING

Gustave Roussy

Villejuif, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Florence JOLY, Prof

Role: CONTACT

02 31 45 50 50

Facility Contacts

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Laura MANSI, MD

Role: primary

Florence JOLY, Prof

Role: primary

Elsa KALBACHER, MD

Role: primary

33473278080

Olivia LE SAUX, MD

Role: primary

Frederic SELLES, MD

Role: primary

Claire GERVAIS, MD

Role: primary

Anne Catherine PIKETTY, MD

Role: primary

Diana BELLO ROUFAI, MD

Role: primary

Jerome MARTIN-BABAU, MD

Role: primary

Diana BELLO ROUFAI, MD

Role: primary

Aurélie BENETON, MD

Role: primary

Virginie LEROY, MD

Role: primary

Patricia PAUTIER, MD

Role: primary

Other Identifiers

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2023-A02554-41

Identifier Type: -

Identifier Source: org_study_id

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