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
AFTERGYN2
1 other identifier
interventional
268
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2024
Longer than P75 for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 7, 2024
CompletedFirst Submitted
Initial submission to the registry
August 12, 2024
CompletedFirst Posted
Study publicly available on registry
August 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 7, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 7, 2028
January 8, 2026
January 1, 2026
3.3 years
August 12, 2024
January 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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.
12 months after delivery of personalized post-cancer plan, i.e. about 14 months after inclusion
Study Arms (3)
Experimental group
EXPERIMENTALDelivery of personalized post-cancer plan with multidisciplinary assessment of oncology support care needs in a day hospital
Control group
ACTIVE COMPARATORDelivery of a personalized post-cancer plan without a day hospital
Cohort
OTHERFollow-up as part of an observational cohort
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2024
First Posted
August 14, 2024
Study Start
June 7, 2024
Primary Completion (Estimated)
September 7, 2027
Study Completion (Estimated)
June 7, 2028
Last Updated
January 8, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share