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Trial Title:
Optimize the Support of Patients in Pelvic Onco-gynecology Through Adapted Support Care in the Post-cancer Period. AFTERGYN Pilot Phase
NCT ID:
NCT05731661
Condition:
Long Term Cancer Side Effects
Supportive Care in Cancer
Cancer Survivorship Care Plan
Advanced Nurse Practitioner
Pelvic Gynecological Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Participant)
Intervention:
Intervention type:
Other
Intervention name:
Day hospitalization in support care with meeting with support care professionals and coordination of actions by the advanced practice nurse
Description:
During this day hospitalization, patients will meet with different specialized
professionals depending on the support care needs identified.
Arm group label:
Delivery of a Personalized Post-Cancer Plan (PPAC) with a day hospitalization in supportive care
Intervention type:
Other
Intervention name:
Delivery of useful information according to support care needs, concerning support care professionals in the city
Description:
Delivery of useful information according to support care needs, concerning support care
professionals in the city
Arm group label:
Delivery of a Personalized Post-Cancer Plan (PPAC) without day hospitalization in supportive care
Intervention type:
Other
Intervention name:
Delivery of a personalized post-cancer plan
Description:
Delivery of a personalized post-cancer plan
Arm group label:
Delivery of a Personalized Post-Cancer Plan (PPAC) with a day hospitalization in supportive care
Arm group label:
Delivery of a Personalized Post-Cancer Plan (PPAC) without day hospitalization in supportive care
Arm group label:
Observational cohort
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Francois Baclesse
Address:
City:
Caen
Zip:
14076
Country:
France
Status:
Recruiting
Contact:
Last name:
GERNIER Francois
Phone:
0231455050
Email:
f.gernier@baclesse.unicancer.fr
Contact backup:
Last name:
GRELLARD Jean-Michel
Email:
jm.grellard@baclesse.unicancer.fr
Investigator:
Last name:
GERNIER François
Email:
Principal Investigator
Start date:
January 9, 2023
Completion date:
July 9, 2025
Lead sponsor:
Agency:
Centre Francois Baclesse
Agency class:
Other
Collaborator:
Agency:
Ligue contre le cancer, France
Agency class:
Other
Source:
Centre Francois Baclesse
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05731661
