Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2025-12-28 @ 11:49 AM
Study NCT ID:
NCT05731661
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-25
First Post:
2023-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimize the Support of Patients in Pelvic Onco-gynecology Through Adapted Support Care in the Post-cancer Period. AFTERGYN Pilot Phase
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 99}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-02-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2023-01-23', 'studyFirstSubmitQcDate': '2023-02-07', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'timeFrame': 'Up to 4 months'}], 'secondaryOutcomes': [{'measure': "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", 'timeFrame': 'Up to 4 months'}, {'measure': 'Description of the types of oncological support care needs identified', 'timeFrame': 'Up to 4 months'}, {'measure': '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', 'timeFrame': 'Up to 4 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Long Term Cancer Side Effects', 'Supportive Care in Cancer', 'Cancer Survivorship Care Plan', 'Advanced Nurse Practitioner', 'Pelvic Gynecological Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nIt 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient \\> 18 years old\n* Patient in complete remission after first-line treatment for endometrial or ovarian/fallopian tube/peritoneal cancer\n* Patient having completed her initial treatment; patients with maintenance treatments are eligible\n* Mastery of the French language\n* Patient with a telephone line\n* Patient affiliated to a social security scheme\n* Signature of informed consent before any specific procedure related to the study\n\nExclusion Criteria:\n\n* Any associated medical or psychiatric conditions that could compromise the patient's ability to participate in the study\n* Patient with locoregional or metastatic recurrence\n* Patient deprived of liberty, under guardianship or curatorship\n* Simultaneous participation in a therapeutic clinical trial"}, 'identificationModule': {'nctId': 'NCT05731661', 'acronym': 'AFTERGYN', 'briefTitle': 'Optimize the Support of Patients in Pelvic Onco-gynecology Through Adapted Support Care in the Post-cancer Period. AFTERGYN Pilot Phase', 'organization': {'class': 'OTHER', 'fullName': 'Centre Francois Baclesse'}, 'officialTitle': 'Optimize the Support of Patients in Pelvic Onco-gynecology Through Adapted Support Care in the Post-cancer Period. AFTERGYN Pilot Phase', 'orgStudyIdInfo': {'id': '2022-A01872-41'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Delivery of a Personalized Post-Cancer Plan (PPAC) with a day hospitalization in supportive care', 'interventionNames': ['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']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Delivery of a Personalized Post-Cancer Plan (PPAC) without day hospitalization in supportive care', 'interventionNames': ['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']}, {'type': 'OTHER', 'label': 'Observational cohort', 'interventionNames': ['Other: Delivery of a personalized post-cancer plan']}], 'interventions': [{'name': 'Day hospitalization in support care with meeting with support care professionals and coordination of actions by the advanced practice nurse', 'type': 'OTHER', 'description': 'During this day hospitalization, patients will meet with different specialized professionals depending on the support care needs identified.', 'armGroupLabels': ['Delivery of a Personalized Post-Cancer Plan (PPAC) with a day hospitalization in supportive care']}, {'name': 'Delivery of useful information according to support care needs, concerning support care professionals in the city', 'type': 'OTHER', 'description': 'Delivery of useful information according to support care needs, concerning support care professionals in the city', 'armGroupLabels': ['Delivery of a Personalized Post-Cancer Plan (PPAC) without day hospitalization in supportive care']}, {'name': 'Delivery of a personalized post-cancer plan', 'type': 'OTHER', 'description': 'Delivery of a personalized post-cancer plan', 'armGroupLabels': ['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']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14076', 'city': 'Caen', 'country': 'France', 'facility': 'Centre Francois Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Francois Baclesse', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ligue contre le cancer, France', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}