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

Sponsor
Centre Francois Baclesse (Other)
Overall Status
Recruiting
CT.gov ID
NCT05731661
Collaborator
Ligue contre le cancer, France (Other)
99
1
3
30
3.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Day hospitalization in support care with meeting with support care professionals and coordination of actions by the advanced practice nurse
  • 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
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
99 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Optimize the Support of Patients in Pelvic Onco-gynecology Through Adapted Support Care in the Post-cancer Period. AFTERGYN Pilot Phase
Actual Study Start Date :
Jan 9, 2023
Anticipated Primary Completion Date :
Jan 9, 2025
Anticipated Study Completion Date :
Jul 9, 2025

Arms and Interventions

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 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: Delivery of a personalized post-cancer plan
Delivery of a personalized post-cancer plan

Other: Observational cohort

Other: Delivery of a personalized post-cancer plan
Delivery of a personalized post-cancer plan

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. 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]

  2. Description of the types of oncological support care needs identified [Up to 4 months]

  3. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Francois Baclesse Caen France 14076

Sponsors and Collaborators

  • Centre Francois Baclesse
  • Ligue contre le cancer, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT05731661
Other Study ID Numbers:
  • 2022-A01872-41
First Posted:
Feb 16, 2023
Last Update Posted:
Feb 16, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 16, 2023