NCT06553612 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 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Francois Baclesse |
| Condition | Gynecologic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 268 participants |
| Start Date | 2024-06-07 |
| Primary Completion | 2027-09-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 268 participants in total. It began in 2024-06-07 with a primary completion date of 2027-09-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06553612 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Gynecologic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06553612 currently recruiting?
Yes, NCT06553612 is actively recruiting participants. Contact the research team at f.joly@baclesse.unicancer.fr for enrollment information.
Where is the NCT06553612 trial being conducted?
This trial is being conducted at Besançon, France, Caen, France, Clermont-Ferrand, France, Lyon, France and 9 additional locations.
Who is sponsoring the NCT06553612 clinical trial?
NCT06553612 is sponsored by Centre Francois Baclesse. The trial plans to enroll 268 participants.
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