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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-01600 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2016-0298 | Other Identifier | M D Anderson Cancer Center |
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Accrual Limit
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
PRIMARY OBJECTIVES:
1. To test the effects of online genetic education versus telephone genetic counseling on cancer-risk distress.
SECONDARY OBJECTIVES:
OUTLINE: Patients are randomized into 1 of 4 arms.
ARM A: Patients watch genetic testing online educational video and receive genetic testing online test results report.
ARM B: Patients watch genetic testing online educational video, receive genetic testing online test results report, and post-telephone genetic counseling.
ARM C: Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, genetic testing online test results report, and post-telephone genetic counseling.
ARM D: Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, and genetic testing online test results report.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (online education) | Experimental | Patients watch genetic testing online educational video and receive genetic testing online test results report. |
|
| Arm B (online education, post telephone counseling) | Experimental | Patients watch genetic testing online educational video, receive genetic testing online test results report, and post-telephone genetic counseling. |
|
| Arm C (online education, pre- and post-telephone counselling) | Active Comparator | Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, genetic testing online test results report, and post-telephone genetic counseling. |
|
| Arm D (online education, pre-telephone counseling) | Experimental | Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, and genetic testing online test results report. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Watch genetic testing online educational video |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean cancer stress scores | 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. Subscales are summed to compute the total score. | Up to 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roni Wilke | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States | ||
| University of Washington Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37707822 | Derived | 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. | |
| 36155347 |
| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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|
| Genetic Counseling | Other | Receive post-telephone genetic counseling |
|
| Genetic Counseling | Other | Receive pre-telephone genetic counseling |
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Seattle |
| Washington |
| 98195 |
| United States |
| Derived |
| 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. |
| 31266460 | Derived | 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. |
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D005817 | Genetic Counseling |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
| D033142 | Genetic Services |
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