Optimize the Support of Patients in Pelvic Onco-gynecology Through Adapted Support Care in the Post-cancer Period. AFTERGYN Pilot Phase

Not Applicable

Recruiting

• Conditions: Cancer Survivorship Care Plan; Long Term Cancer Side Effects; Supportive Care in Cancer; Advanced Nurse Practitioner; Pelvic Gynecological Cancer

• Registration Number: NCT05731661
• Lead Sponsor: Centre Francois Baclesse

Brief Summary

While the sequelae and toxicities after ovarian and endometrial cancer treatments are well described in the literature, the actual needs of patients for supportive oncology care remain poorly documented. Moreover, there is no data available to estimate the complexity of the oncological support care actions to be implemented.

It is expected that an evaluation of the needs for supportive oncology care and its organization in day hospitalization for supportive oncology care will lead to an improvement in personalized post-cancer follow-up for these patients and to an improvement in their long-term quality of life.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-09
• Study First Submitted: 2023-01-23
• Study First Submitted QC: 2023-02-07
• Study First Posted: 2023-02-16
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27
• Primary Completion: 2026-08-25
• Study Completion: 2027-02-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 99

Inclusion Criteria

• Patient > 18 years old
• Patient in complete remission after first-line treatment for endometrial or ovarian/fallopian tube/peritoneal cancer
• Patient having completed her initial treatment; patients with maintenance treatments are eligible
• Mastery of the French language
• Patient with a telephone line
• Patient affiliated to a social security scheme
• Signature of informed consent before any specific procedure related to the study

Exclusion Criteria

• Any associated medical or psychiatric conditions 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of patients who used at least one of the oncology support services recommended in the Personalized After-Cancer Care Plan within 4 months of receiving the Personalized After-Cancer Care Plan	Up to 4 months

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with sequelae after the initial treatment of their cancer, as well as the type and grade of the sequelae, based on the National Cancer Institute's screening grids (levels 1 and 2) during the consultation with a nurse referent	Up to 4 months
Description of the types of oncological support care needs identified	Up to 4 months
Proportion of patients with identified cancer care needs (at least one cancer care need to be implemented) 4 months after the submission of the Personalized Cancer Care Plan	Up to 4 months

Trial Locations

Locations (1)

Centre Francois Baclesse; 🇫🇷 Caen, France