Clinical trial NCT06553612: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gynecologic Cancer
Remission
Keywords: supportive oncology care
personalized post-cancer plan
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2024-08-14
Enrollment: 268
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


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

Primary outcomes:
measure: Compare the proportion of patients for whom the supportive oncology care recommended in the personalized post-cancer plan has been implemented.
timeFrame: 6 months after delivery of personalized post-cancer plan, i.e. about 8 months after inclusion
Secondary outcomes:
measure: 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.
timeFrame: 12 months after delivery of personalized post-cancer plan, i.e. about 14 months after inclusion
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU, Besançon
city: Caen
country: France
facility: François Baclesse
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin
city: Lyon
country: France
facility: Centre Léon Bérard
city: Paris
country: France
facility: Hopital Diaconesses Croix Saint-Simon
city: Paris
country: France
facility: Hopital Europeen George Pompidou
city: Paris
country: France
facility: Hôpital COCHIN
city: Paris
country: France
facility: Institut Curie
city: Plérin
country: France
facility: Hopital privé des Côtes d'Armor
city: Saint Etienne
country: France
facility: CHU, Saint Etienne
city: St Cloud
country: France
facility: Institut Curie, St Cloud
city: Strasbourg
country: France
facility: Institut de Cancérologie de Strasbourg
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
References: