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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multidisciplinary assessment, Standard assesment, Observational cohort.
- Who it may be relevant to
- Registry conditions: Gynecologic Cancer, Remission. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Multidisciplinary assessment
Delivery of a personalized post-cancer plan with multidisciplinary assessment of oncology support care needs in a day hospital - Other Standard assesment
Delivery of a personalized post-cancer plan without a day hospital - Other Observational cohort
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
Primary outcome measures
- 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]
Secondary outcome measures (1)
- 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. [Time frame: 12 months after delivery of personalized post-cancer plan, i.e. about 14 months after inclusion]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
France · 13 centers
- CHU, Besançon — Besançon
- François Baclesse — Caen
- Centre Jean Perrin — Clermont-Ferrand
- Centre Léon Bérard — Lyon
- Hopital Diaconesses Croix Saint-Simon — Paris
- Hopital Europeen George Pompidou — Paris
- Hôpital COCHIN — Paris
- Institut Curie — Paris
- … and 5 more centers
Identifiers
NCT: NCT06553612 · 2023-A02554-41