Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-02-27 @ 6:30 AM
Study NCT ID:
NCT02686918
Status:
UNKNOWN
Last Update Posted:
2016-02-22
First Post:
2016-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Assessment of a Patients Follow-up Visit Receiving Trastuzumab Subcutaneous by Advanced Practice Nurse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-16', 'studyFirstSubmitDate': '2016-02-08', 'studyFirstSubmitQcDate': '2016-02-16', 'lastUpdatePostDateStruct': {'date': '2016-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of consultation requiring a medical advice between IPA and oncologist', 'timeFrame': '1 year', 'description': 'Estimate the correlation between the IPA and the oncologist about whether or not a medical opinion during the consultation'}], 'secondaryOutcomes': [{'measure': 'Percentage of consultations delegated to the IPA', 'timeFrame': '1 year', 'description': 'The oncologist estimate the percentage of consultations can be delegated to the IPA'}, {'measure': 'Physician satisfaction questionnaire', 'timeFrame': '1 year', 'description': 'Physician satisfaction questionnaire of the delegation of his consultations to the IPA'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Neoplasms']}, 'descriptionModule': {'briefSummary': 'The main of this study is to assess the feasibility of a patients follow-up visit receiving trastuzumab subcutaneous by Advanced Practice Nurse.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient care at the Cancer Institute Lucien Neuwirth\n* Patient aged over 18 years\n* Patient with breast cancer overexpressing HER2 adjuvant\n* Patient having finished their chemotherapy treatment with IV followed the oncologist day hospital\n* Patient under Trastzumab subcutaneously\n* Patient affiliated or entitled to a social security scheme (mandatory requirement for all studies)\n\nExclusion Criteria:\n\n* Refusal to participate, most patient protected under guardianship.\n* Patient in inability to understand the course of the study\n* Patient with documented history of cognitive or psychiatric disorders.\n* Patients pregnant or lactating\n* Patients under guardianship or curatorship'}, 'identificationModule': {'nctId': 'NCT02686918', 'acronym': 'TIPA', 'briefTitle': 'Feasibility Assessment of a Patients Follow-up Visit Receiving Trastuzumab Subcutaneous by Advanced Practice Nurse', 'organization': {'class': 'OTHER', 'fullName': 'Institut de Cancérologie de la Loire'}, 'officialTitle': 'Feasibility Assessment of a Patients Follow-up Visit Receiving Trastuzumab Subcutaneous by Advanced Practice Nurse - TIPA', 'orgStudyIdInfo': {'id': '2016-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'consultation by Advanced Practice Nurse.', 'description': 'During consultations, patients will be seen successively by Advanced Practice Nurse and referent oncologist.', 'interventionNames': ['Other: Advanced Practice Nurse consultation']}], 'interventions': [{'name': 'Advanced Practice Nurse consultation', 'type': 'OTHER', 'armGroupLabels': ['consultation by Advanced Practice Nurse.']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mathieu ORIOL, MD', 'role': 'CONTACT', 'email': 'mathieu.oriol@icloire.fr', 'phone': '04 77 91 70 71'}, {'name': 'Cécile MIGALA, IPA', 'role': 'CONTACT', 'email': 'cecile.migala@icloire.fr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de Cancérologie de la Loire', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}