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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCentre Francois Baclesse

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multidisciplinary assessment

    Other intervention

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

  • Standard assesment

    Other intervention

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

  • Observational cohort

    Other intervention

    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

Treatment groups

268 Participants
are divided into 3 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention
Group C: CohortOther 1 intervention

Trial outcomes

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.

Time frame
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.

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

Other outcomes

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