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

Pelvic Gynecological Cancer Clinical Trial

— AFTERGYN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05731661
• Other study ID #: 2022-A01872-41
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2023
• Est. completion date: July 9, 2025

Study information

• Verified date: July 2023
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 99
• Est. completion date: July 9, 2025
• Est. primary completion date: January 9, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Gynecological Cancer

Intervention

Other:
• Day hospitalization in support care with meeting with support care professionals and coordination of actions by the advanced practice nurse
During this day hospitalization, patients will meet with different specialized professionals depending on the support care needs identified.
• Delivery of useful information according to support care needs, concerning support care professionals in the city
Delivery of useful information according to support care needs, concerning support care professionals in the city
• Delivery of a personalized post-cancer plan
Delivery of a personalized post-cancer plan

Locations

Country	Name	City	State
France	Centre Francois Baclesse	Caen

Sponsors (2)

Lead Sponsor	Collaborator
Centre Francois Baclesse	Ligue contre le cancer, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Description of the types of oncological support care needs identified		Up to 4 months
Secondary	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