Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-28 @ 8:35 AM
Study NCT ID:
NCT06703567
Status:
RECRUITING
Last Update Posted:
2024-12-10
First Post:
2024-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IMproving PAtient UndeRstanding of GEP TEst Results: Phase 4
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 82}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2024-11-21', 'studyFirstSubmitQcDate': '2024-11-21', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GEP Knowledge Evaluation', 'timeFrame': '1 week', 'description': 'Collection of Gene Expression Profiling (GEP) Knowledge Questionnaire (higher total score indicates better understanding)'}], 'secondaryOutcomes': [{'measure': 'Anxiety assessment', 'timeFrame': '1 week', 'description': 'Collection of Spielberger State/Trait Anxiety Inventory (STAI) questionnaire (minimum value: 1, maximum value: 4 - higher scores signify greater anxiety)'}, {'measure': 'Decision making assessment', 'timeFrame': '1 week', 'description': 'Collection of Decisional Conflict Scale questionnaire (minimum value: 1, maximum value: 5 - higher scores mean a greater agreement with the statement)'}, {'measure': 'Reaction to uncertain situations assessment', 'timeFrame': '1 week', 'description': 'Collection of Intolerance of Uncertainty Scale Short-Form (IUS-12) questionnaire (minimum value: 1, maximum value: 5 - higher scores mean a greater agreement with the statement)'}, {'measure': 'Physician confidence/satisfaction assessment', 'timeFrame': '1 week', 'description': 'Collection of Confidence/satisfaction with GEP test result discussions questionnaire (higher scores indicate better satisfaction)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Early breast cancer', 'Gene Expression Profiling', 'Oncotype DX'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': "The primary aim of the study is to determine if provision of a patient information film about Oncotype DX improves patients' knowledge and understanding about Gene Expression Profiling (GEP) test and risk of recurrence results in early breast cancer (EBC) patients, identified by their clinical teams as potentially benefiting from having their tumor samples sent for GEP analysis.", 'detailedDescription': 'Advances made in our understanding of the molecular biology of breast cancer have improved diagnostic testing and therapeutic options available to patients. Importantly results from genomic testing provide more accurate tailoring of treatments potentially enhancing the benefit to harm ratio by only offering adjuvant chemotherapy to those patients at highest risk of recurrence, and sparing those at lower risk the unwanted side effects of cytotoxic treatment. Conversations about risks and optimal treatments can be complex.\n\nTo aid understanding about GEP tests many clinical teams provide patients with information leaflets about GEP testing. Unfortunately these are often written by either academic or commercial sponsors and designed to meet certain ethical and regulatory guidelines rather than effectively educate the end-user.\n\nThere is some evidence that user-friendly patient information films might enhance patient knowledge and understanding and are more accessible to certain individuals, especially those with low literacy.\n\nIMPARTER project has developed eight-minute film explaining why Oncotype DX GEP tests is used in EBC, what it is, and how the results help determine whether or not chemotherapy is recommended as a useful treatment option.\n\nThis study wish to examine the utility of the information film in the clinic setting with EBC patients identified by their clinical teams as potentially benefiting from having their tumor samples sent for GEP analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First presentation of early stage breast cancer with all known disease surgically removed\n* Estrogen Receptor (ER) positive and Human Epidermal growth factor Receptor 2 (HER-2) negative\n* No clear decision on whether chemotherapy should be given as adjunct based on current prognostic criteria\n* Consented to GEP testing\n* Able to give full informed consent to IMPARTER study\n* Good comprehension of the Italian language\n* Access to internet connection and devices (e.g. smart phone, tablet, laptop or desktop computer)\n\nExclusion Criteria:\n\n* Other breast cancer diagnosis (e.g. Ductal carcinoma in situ, Metastatic)\n* Unable to give fully informed consent\n* Under 18 years of age\n* Unable to understand and speak Italian\n* No access to internet connection or devices'}, 'identificationModule': {'nctId': 'NCT06703567', 'acronym': 'IMPARTER', 'briefTitle': 'IMproving PAtient UndeRstanding of GEP TEst Results: Phase 4', 'organization': {'class': 'OTHER', 'fullName': 'European Institute of Oncology'}, 'officialTitle': 'IMproving PAtient UndeRstanding of GEP TEst Results: Phase 4', 'orgStudyIdInfo': {'id': 'IEO 1924'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard', 'description': 'GEP test information (as per standard hospital policy)', 'interventionNames': ['Behavioral: Standard Policy']}, {'type': 'EXPERIMENTAL', 'label': 'GEP film', 'description': 'Standard policy + the relevant GEP information film', 'interventionNames': ['Behavioral: Standard Policy + GEP Information Film']}], 'interventions': [{'name': 'Standard Policy', 'type': 'BEHAVIORAL', 'description': 'Patients will receive information about the GEP test by clinical teams', 'armGroupLabels': ['Standard']}, {'name': 'Standard Policy + GEP Information Film', 'type': 'BEHAVIORAL', 'description': 'Patients will receive information about the GEP test by clinical teams and, after consultation with physician, they will be sent a link to view the film regarding OncotypeDX', 'armGroupLabels': ['GEP film']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20141', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gabriella Pravettoni, MD', 'role': 'CONTACT', 'email': 'gabriella.pravettoni@ieo.it', 'phone': '+39 0257489731'}], 'facility': 'European Institute of Oncology', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Gabriella Pravettoni, MD', 'role': 'CONTACT', 'email': 'gabriella.pravettoni@ieo.it', 'phone': '+39 0257489731'}, {'name': 'Mara Negri', 'role': 'CONTACT', 'email': 'mara.negri@ieo.it', 'phone': '+39 0257489536'}], 'overallOfficials': [{'name': 'Gabriella Pravettoni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'European Istitute of Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Institute of Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}