RecruitingNot ApplicableNCT06553612

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


Sponsor

Centre Francois Baclesse

Enrollment

268 participants

Start Date

Jun 7, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria7

  • 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 Criteria4

  • 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

Interventions

OTHERMultidisciplinary assessment

Delivery of a personalized post-cancer plan with multidisciplinary assessment of oncology support care needs in a day hospital

OTHERStandard assesment

Delivery of a personalized post-cancer plan without a day hospital

OTHERObservational 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


Locations(13)

CHU, Besançon

Besançon, France

François Baclesse

Caen, France

Centre Jean Perrin

Clermont-Ferrand, France

Centre Léon Bérard

Lyon, France

Hopital Diaconesses Croix Saint-Simon

Paris, France

Hopital Europeen George Pompidou

Paris, France

Hôpital COCHIN

Paris, France

Institut Curie

Paris, France

Hopital privé des Côtes d'Armor

Plérin, France

Institut Curie, St Cloud

Saint-Cloud, France

CHU, Saint Etienne

Saint-Etienne, France

CHU

Strasbourg, France

Gustave Roussy

Villejuif, France

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NCT06553612


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