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

Not Applicable

Recruiting

• Conditions: Gynecologic Cancer; Remission
• Interventions: Other: Standard assesment; Other: Observational cohort; Other: Multidisciplinary assessment

• Registration Number: NCT06553612
• Lead Sponsor: Centre Francois Baclesse

Brief 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. 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

Not available

Study Timeline

• Study Start: 2024-06-07
• Status Verified: 2024-07
• Study First Submitted: 2024-08-12
• Study First Submitted QC: 2024-08-12
• Study First Posted: 2024-08-14
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-27
• Primary Completion: 2027-09-07
• Study Completion: 2028-06-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 268

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Standard assesment	Delivery of a personalized post-cancer plan without a day hospital
Cohort	Observational cohort	Follow-up as part of an observational cohort
Experimental group	Multidisciplinary assessment	Delivery of personalized post-cancer plan with multidisciplinary assessment of oncology support care needs in a day hospital

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.	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).

Trial Locations

Locations (13)

François Baclesse; 🇫🇷 Caen, France

Hôpital COCHIN; 🇫🇷 Paris, France

Institut Curie; 🇫🇷 Paris, France

Hopital privé des Côtes d'Armor; 🇫🇷 Plérin, France

Centre Jean Perrin; 🇫🇷 Clermont Ferrand, France

CHU, Besançon; 🇫🇷 Besançon, France

Centre Léon Bérard; 🇫🇷 Lyon, France

Hopital Diaconesses Croix Saint-Simon; 🇫🇷 Paris, France

Hopital Europeen George Pompidou; 🇫🇷 Paris, France

CHU, Saint Etienne; 🇫🇷 Saint Etienne, France

Institut Curie, St Cloud; 🇫🇷 St Cloud, France

Institut de Cancérologie de Strasbourg; 🇫🇷 Strasbourg, France

Gustave Roussy; 🇫🇷 Villejuif, France