Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-01-13 @ 3:26 AM
Study NCT ID:
NCT02993068
Status:
SUSPENDED
Last Update Posted:
2025-08-17
First Post:
2016-12-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}], 'ancestors': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018479', 'term': 'Early Intervention, Educational'}, {'id': 'D004522', 'term': 'Educational Status'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D005817', 'term': 'Genetic Counseling'}], 'ancestors': [{'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D033142', 'term': 'Genetic Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5200}}, 'statusModule': {'whyStopped': 'Accrual Limit', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-04-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2016-12-07', 'studyFirstSubmitQcDate': '2016-12-12', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean cancer stress scores', 'timeFrame': 'Up to 4 years', 'description': 'Mean cancer stress scores are measured on the Impact of Events Scale (IES), a 15-item self-report measure that assesses subjective distress caused by traumatic events, which may include a positive genetic test result.There are two subscales, Intrusion and Avoidance, used to calculate a total. The range for Intrusion is 0-35 and the range for Avoidance is 0-40. The range of the total score is 0-75. Higher scores reflect more stressful impact, and therefore, a worse outcome.\n\nSubscales are summed to compute the total score.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['BARD1 Gene Mutation', 'BRCA1 Gene Mutation', 'BRCA2 Gene Mutation', 'BRIP1 Gene Mutation', 'Estrogen Receptor Negative', 'HER2/Neu Negative', 'MLH1 Gene Mutation', 'MSH2 Gene Mutation', 'MSH6 Gene Mutation', 'PALB2 Gene Mutation', 'PMS2 Gene Mutation', 'Progesterone Receptor Negative', 'RAD51C Gene Mutation', 'RAD51D Gene Mutation', 'Triple-Negative Breast Carcinoma']}, 'referencesModule': {'references': [{'pmid': '37707822', 'type': 'DERIVED', 'citation': "Swisher EM, Rayes N, Bowen D, Peterson CB, Norquist BM, Coffin T, Gavin K, Polinsky D, Crase J, Bakkum-Gamez JN, Blank SV, Munsell MF, Nebgen D, Fleming GF, Olopade OI, Law S, Zhou A, Levine DA, D'Andrea A, Lu KH. Remotely Delivered Cancer Genetic Testing in the Making Genetic Testing Accessible (MAGENTA) Trial: A Randomized Clinical Trial. JAMA Oncol. 2023 Nov 1;9(11):1547-1555. doi: 10.1001/jamaoncol.2023.3748."}, {'pmid': '36155347', 'type': 'DERIVED', 'citation': "Coffin T, Bowen D, Lu K, Swisher EM, Rayes N, Norquist B, Blank SV, Levine DA, Bakkum-Gamez JN, Fleming GF, I Olopade O, Romero I, D'Andrea A, Nebgen DR, Peterson C, Munsell MF, Gavin K, Crase J, Polinsky D, Lechner R. Using Social Media to Facilitate Communication About Women's Testing: Tool Validation Study. JMIR Form Res. 2022 Sep 26;6(9):e35035. doi: 10.2196/35035."}, {'pmid': '31266460', 'type': 'DERIVED', 'citation': 'Rayes N, Bowen DJ, Coffin T, Nebgen D, Peterson C, Munsell MF, Gavin K, Lechner R, Crase J, Polinsky D, Romero I, Blank SV, Levine DA, Norquist BM, Swisher EM, Lu KH. MAGENTA (Making Genetic testing accessible): a prospective randomized controlled trial comparing online genetic education and telephone genetic counseling for hereditary cancer genetic testing. BMC Cancer. 2019 Jul 2;19(1):648. doi: 10.1186/s12885-019-5868-x.'}], 'seeAlsoLinks': [{'url': 'https://www.mdanderson.org', 'label': 'MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'This randomized clinical trial studies how well online genetics educational video with or without pre- and/or post-telephone genetics counseling works in assessing cancer-risk distress in patients with triple negative breast cancer. Online genetic education and telephone genetic counseling may help the doctors learn the stress a person feels about their risk of cancer.', 'detailedDescription': "PRIMARY OBJECTIVES:\n\n1\\. To test the effects of online genetic education versus telephone genetic counseling on cancer-risk distress.\n\nSECONDARY OBJECTIVES:\n\n1. To test the effects of online genetic education versus telephone genetic counseling on testing completion rates.\n2. To evaluate the role of psychological and social variables in women's reactions to genetic testing for ovarian cancer risk with variable education strategies.\n3. To consider the effects of variations of genetic education/counseling on genetic knowledge, satisfaction with the decision to undergo testing, and family communication.\n4. To examine the cancer screening and prevention behaviors, as well as cascade testing behaviors among patients who tested positive for a pathogenic variant.\n5. To determine factors contributing to non-completion of genetic testing in subjects enrolled in a genetic testing trial.\n6. To determine the impact of pre- and/or post-test genetic counseling on family communication, genetic testing concerns and screening behaviors.\n\nOUTLINE: Patients are randomized into 1 of 4 arms.\n\nARM A: Patients watch genetic testing online educational video and receive genetic testing online test results report.\n\nARM B: Patients watch genetic testing online educational video, receive genetic testing online test results report, and post-telephone genetic counseling.\n\nARM C: Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, genetic testing online test results report, and post-telephone genetic counseling.\n\nARM D: Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, and genetic testing online test results report."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 30 or older. Note: Participants must meet each of Criteria 1-4.\n* Have access to a healthcare provider and be willing to share genetic results with that provider\n* Have at least one ovary\n* Have a valid United States mailing address for receipt of saliva kit\n* Participants must meet any one of the following 6 criteria:\n* Diagnosed with breast cancer at age 45 or younger\n* Diagnosed with triple negative (negative for estrogen receptor, progesterone receptor and not human epidermal growth factor receptor 2 \\[Her2\\] amplified) breast cancer at 60 or younger\n* Have one blood relative with a mutation in BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, BARD1, MSH2, MSH6, MLH1, or PMS2\n* Have one relative with ovarian cancer\n* Have at least 2 relatives with breast cancer on the same side of the family, one of which is =\\< 50 years of age\n* Have one male relative with breast cancer\n\nExclusion Criteria:\n\n* Personal history of ovarian cancer\n* Unable to read, speak, and understand English\n* Unable to provide informed consent\n* Unwilling to complete baseline and follow-up questionnaires\n* Unable to access the internet\n* Previous genetic testing or counseling regarding cancer risk\n* Previous bone marrow transplant\n* Previous blood transfusion (7 days prior to genetic testing)\n* Active hematologic malignancy (cancer that begins in blood-forming tissue, such as leukemia or lymphoma)'}, 'identificationModule': {'nctId': 'NCT02993068', 'briefTitle': 'Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible)', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible)', 'orgStudyIdInfo': {'id': '2016-0298'}, 'secondaryIdInfos': [{'id': 'NCI-2017-01600', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2016-0298', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A (online education)', 'description': 'Patients watch genetic testing online educational video and receive genetic testing online test results report.', 'interventionNames': ['Other: Educational Intervention', 'Other: Laboratory Biomarker Analysis', 'Other: Questionnaire Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B (online education, post telephone counseling)', 'description': 'Patients watch genetic testing online educational video, receive genetic testing online test results report, and post-telephone genetic counseling.', 'interventionNames': ['Other: Educational Intervention', 'Other: Genetic Counseling', 'Other: Laboratory Biomarker Analysis', 'Other: Questionnaire Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm C (online education, pre- and post-telephone counselling)', 'description': 'Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, genetic testing online test results report, and post-telephone genetic counseling.', 'interventionNames': ['Other: Educational Intervention', 'Other: Genetic Counseling', 'Other: Laboratory Biomarker Analysis', 'Other: Questionnaire Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Arm D (online education, pre-telephone counseling)', 'description': 'Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, and genetic testing online test results report.', 'interventionNames': ['Other: Educational Intervention', 'Other: Genetic Counseling', 'Other: Laboratory Biomarker Analysis', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Educational Intervention', 'type': 'OTHER', 'otherNames': ['Education for Intervention', 'Intervention by Education', 'Intervention through Education', 'Intervention, Educational'], 'description': 'Watch genetic testing online educational video', 'armGroupLabels': ['Arm A (online education)', 'Arm B (online education, post telephone counseling)', 'Arm C (online education, pre- and post-telephone counselling)', 'Arm D (online education, pre-telephone counseling)']}, {'name': 'Genetic Counseling', 'type': 'OTHER', 'description': 'Receive post-telephone genetic counseling', 'armGroupLabels': ['Arm B (online education, post telephone counseling)', 'Arm C (online education, pre- and post-telephone counselling)']}, {'name': 'Genetic Counseling', 'type': 'OTHER', 'description': 'Receive pre-telephone genetic counseling', 'armGroupLabels': ['Arm C (online education, pre- and post-telephone counselling)', 'Arm D (online education, pre-telephone counseling)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm A (online education)', 'Arm B (online education, post telephone counseling)', 'Arm C (online education, pre- and post-telephone counselling)', 'Arm D (online education, pre-telephone counseling)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm A (online education)', 'Arm B (online education, post telephone counseling)', 'Arm C (online education, pre- and post-telephone counselling)', 'Arm D (online education, pre-telephone counseling)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Roni Wilke', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}