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

NCT05731661 | Active Not Recruiting

• 1 other identifier: 2022-A01872-41
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (3)

Delivery of a Personalized Post-Cancer Plan (PPAC) with a day hospitalization in supportive care

EXPERIMENTAL

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

Delivery of a Personalized Post-Cancer Plan (PPAC) without day hospitalization in supportive care

ACTIVE COMPARATOR

Other: Delivery of useful information according to support care needs, concerning support care professionals in the city; Other: Delivery of a personalized post-cancer plan

Observational cohort

OTHER

Other: Delivery of a personalized post-cancer plan

Interventions

Day hospitalization in support care with meeting with support care professionals and coordination of actions by the advanced practice nurse OTHER

During this day hospitalization, patients will meet with different specialized professionals depending on the support care needs identified.

Delivery of a Personalized Post-Cancer Plan (PPAC) with a day hospitalization in supportive care

Delivery of useful information according to support care needs, concerning support care professionals in the city OTHER

Delivery of useful information according to support care needs, concerning support care professionals in the city

Delivery of a Personalized Post-Cancer Plan (PPAC) without day hospitalization in supportive care

Delivery of a personalized post-cancer plan OTHER

Delivery of a personalized post-cancer plan

Delivery of a Personalized Post-Cancer Plan (PPAC) with a day hospitalization in supportive care; Delivery of a Personalized Post-Cancer Plan (PPAC) without day hospitalization in supportive care; Observational cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Francois Baclesse: lead
• Ligue contre le cancer, France: collaborator

Study Sites (1)

Centre Francois Baclesse

Caen, 14076, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 16, 2023
• Study Start: January 9, 2023
• Primary Completion: November 20, 2025
• Study Completion (Estimated): February 25, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)