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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
268
Delivery of a personalized post-cancer plan with multidisciplinary assessment of oncology support care needs in a day hospital
Delivery of a personalized post-cancer plan without a day hospital
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
CHU, Besançon
Besançon, France
RECRUITINGFrançois Baclesse
Caen, France
RECRUITINGCentre Jean Perrin
Clermont-Ferrand, France
NOT_YET_RECRUITINGCentre Léon Bérard
Lyon, France
RECRUITINGHopital Diaconesses Croix Saint-Simon
Paris, France
RECRUITINGHopital Europeen George Pompidou
Paris, France
NOT_YET_RECRUITINGHôpital COCHIN
Paris, France
NOT_YET_RECRUITINGInstitut Curie
Paris, France
NOT_YET_RECRUITINGHopital privé des Côtes d'Armor
Plérin, France
NOT_YET_RECRUITINGInstitut Curie, St Cloud
Saint-Cloud, France
RECRUITING...and 3 more locations
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.
Time frame: 6 months after delivery of personalized post-cancer plan, i.e. about 8 months after inclusion
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).
Time frame: 12 months after delivery of personalized post-cancer plan, i.e. about 14 months after inclusion
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