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

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.

Study Overview

• Status: Recruiting
• Conditions: Long Term Cancer Side Effects; Supportive Care in Cancer; Cancer Survivorship Care Plan; Advanced Nurse Practitioner; Pelvic Gynecological Cancer
• Intervention / Treatment: Other: Day hospitalization in support care with meeting with support care professionals and coordination of actions by the advanced practice nurse; Other: Delivery of a personalized post-cancer plan; Other: Delivery of useful information according to support care needs, concerning support care professionals in the city

• Study Type: Interventional
• Enrollment (Estimated): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14076
    • Recruiting
    • Centre Francois Baclesse
    • Contact: GERNIER Francois; Phone Number: 0231455050; Email: f.gernier@baclesse.unicancer.fr
    • Contact: GRELLARD Jean-Michel; Email: jm.grellard@baclesse.unicancer.fr
    • Principal Investigator: GERNIER François

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Delivery of a Personalized Post-Cancer Plan (PPAC) with a day hospitalization in supportive care	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.; Other: Delivery of a personalized post-cancer plan; Delivery of a personalized post-cancer plan
Active Comparator: Delivery of a Personalized Post-Cancer Plan (PPAC) without day hospitalization in supportive care	Other: Delivery of a personalized post-cancer plan; Delivery of a personalized post-cancer plan; Other: 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
Other: Observational cohort	Other: Delivery of a personalized post-cancer plan; Delivery of a personalized post-cancer plan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Francois Baclesse
• Collaborators: Ligue contre le cancer, France

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Estimated): January 9, 2025
• Study Completion (Estimated): July 9, 2025

Study Registration Dates

• First Submitted: January 23, 2023
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (Actual): February 16, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2022-A01872-41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No