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)

Centre Francois Baclesse

Status: Enrolling

Conditions: Remission; Gynecologic Cancer

Treatments: Other: Multidisciplinary assessment; Other: Observational cohort; Other: Standard assesment

Study type: Interventional

Funder types: Other

Identifiers

NCT06553612

2023-A02554-41

Details and patient eligibility

About

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.

Enrollment: 268 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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268 participants in 3 patient groups

Experimental group

Experimental group

Description:

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

Treatment:

Other: Multidisciplinary assessment

Control group

Active Comparator group

Description:

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

Treatment:

Other: Standard assesment

Cohort

Other group

Description:

Follow-up as part of an observational cohort

Treatment:

Other: Observational cohort