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NCT Number: 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

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.

Recruiting

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Key information

Conditions

Gynecologic Cancer Remission

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU, Besançon, Besançon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multidisciplinary assessment

Other

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

Standard assesment

Other

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

Observational Cohort

Other

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

Primary outcomes

  1. Compare the proportion of patients for whom the supportive oncology care recommended in the personalized post-cancer plan has been implemented.

    Time frame: 6 months after delivery of personalized post-cancer plan, i.e. about 8 months after inclusion

    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.

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.

    Time frame: 12 months after delivery of personalized post-cancer plan, i.e. about 14 months after inclusion

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Florence JOLY, Prof

CONTACT

[email protected]

02 31 45 50 50

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Registry information

Acronym: AFTERGYN2

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Aug 14, 2024
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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