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
NCT Number: NCT06553612
Acronym: AFTERGYN2
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gynecologic Cancer|Remission
Interventions: OTHER: Multidisciplinary assessment|OTHER: Standard assesment|OTHER: Observational cohort
Sponsor: Centre Francois Baclesse
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 268
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-06-07
Completion Date: 2028-06-07
Locations: CHU, Besançon, Besançon, France|François Baclesse, Caen, France|Centre Léon Bérard, Lyon, France|Hopital Diaconesses Croix Saint-Simon, Paris, France|Hôpital COCHIN, Paris, France|Institut Curie, Paris, France|Hopital privé des Côtes d'Armor, Plérin, France|CHU, Saint Etienne, Saint Etienne, France|Institut Curie, St Cloud, St Cloud, France|Institut de Cancérologie de Strasbourg, Strasbourg, France|Gustave Roussy, Villejuif, France

Summary:
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.

Primary Outcome Measures: 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
Secondary Outcome Measures: 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)., 12 months after delivery of personalized post-cancer plan, i.e. about 14 months after inclusion