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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Delivery of personalized post-cancer plan with multidisciplinary assessment of oncology support care needs in a day hospital |
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| Control group | Active Comparator | Delivery of a personalized post-cancer plan without a day hospital |
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| Cohort | Other | Follow-up as part of an observational cohort |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multidisciplinary assessment | Other | Delivery of a personalized post-cancer plan with multidisciplinary assessment of oncology support care needs in a day hospital |
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| Measure | Description | Time Frame |
|---|---|---|
| Compare the proportion of patients for whom the supportive oncology care recommended in the personalized post-cancer plan has been implemented. | The primary criterion is the proportion of patients who have implemented at least one of the supportive oncology treatments recommended in the personalized post-cancer plan within 6 months of receiving the personalized post-cancer plan. | 6 months after delivery of personalized post-cancer plan, i.e. about 8 months after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Proportion of patients presenting, at 12 months, an improvement (reduction in grade according to CTCAE v5.0 criteria) in at least one of the side effects and/or sequelae identified at the end of the initial treatments according to the INCa identification grids (1st and 2nd levels). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florence JOLY, Prof | Contact | 02 31 45 50 50 | f.joly@baclesse.unicancer.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU, Besançon | Recruiting | Besançon | France |
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| Standard assesment | Other | Delivery of a personalized post-cancer plan without a day hospital |
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| 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 |
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| 12 months after delivery of personalized post-cancer plan, i.e. about 14 months after inclusion |
| François Baclesse | Recruiting | Caen | France |
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| Centre Jean Perrin | Not yet recruiting | Clermont-Ferrand | France |
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| Centre Léon Bérard | Recruiting | Lyon | France |
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| Hopital Diaconesses Croix Saint-Simon | Recruiting | Paris | France |
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| Hopital Europeen George Pompidou | Not yet recruiting | Paris | France |
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| Hôpital COCHIN | Not yet recruiting | Paris | France |
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| Institut Curie | Not yet recruiting | Paris | France |
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| Hopital privé des Côtes d'Armor | Not yet recruiting | Plérin | France |
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| Institut Curie, St Cloud | Recruiting | Saint-Cloud | France |
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| CHU, Saint Etienne | Not yet recruiting | Saint-Etienne | France |
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| CHU | Recruiting | Strasbourg | France |
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| Gustave Roussy | Recruiting | Villejuif | France |
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