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

Sponsor
Centre Francois Baclesse
Study ID
NCT06553612
Status
Recruiting
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Conditions

  • Gynecologic Cancer
  • Remission

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Multidisciplinary assessment — OTHER
    Delivery of a personalized post-cancer plan with multidisciplinary assessment of oncology support care needs in a day hospital
  • Standard assesment — OTHER
    Delivery of a personalized post-cancer plan without a day hospital
  • Observational cohort — 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

Study Details

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.

Key Dates

First listed
Aug 14, 2024
Start date
Jun 7, 2024
Status verified
Jan 2026
Primary completion
Sep 7, 2027
Completion
Jun 7, 2028

Study Design

Enrollment
268 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Experimental group
    Delivery of personalized post-cancer plan with multidisciplinary assessment of oncology support care needs in a day hospital
  • Active Comparator: Control group
    Delivery of a personalized post-cancer plan without a day hospital
  • Other: Cohort
    Follow-up as part of an observational cohort

Primary Outcome Measure

Compare the proportion of patients for whom the supportive oncology care recommended in the personalized post-cancer plan has been implemented. [ Time Frame: 6 months after delivery of personalized post-cancer plan, i.e. about 8 months after inclusion ]

Central Contacts

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