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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

Study acronym: AFTERGYN2
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Sep 7, 2027 → Sep 7, 2028
See other at-risk trials from Centre Francois Baclesse

Record History

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  1. Primary completion pushed from Sep 7, 2027 to Sep 7, 2028 Show 4 more changesShow less
    • Study completion pushed from Jun 7, 2028 to Jun 7, 2029
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised at 1 of 13 sites
  2. Study sites revised (13)v5
  3. Site details revised at 6 of 13 sitesv4
  4. Study sites: 12 to 13v3
  5. Study sites: 11 to 12v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06553612
Lead Sponsor Centre Francois Baclesse
Conditions
(from sponsor)		 Gynecologic Cancer, Remission
Enrollment 268 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov