Clinical trial · Interventional
Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible)
NCT02993068CI-TRIAL-00124036suspendedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Accrual Limit
Summary
Brief summary (as posted)
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.
Conditions
Conditions (15)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BARD1 Gene Mutation | — | UNRESOLVED | — |
| BRCA1 Gene Mutation | — | UNRESOLVED | — |
| BRCA2 Gene Mutation | — | UNRESOLVED | — |
| BRIP1 Gene Mutation | — | UNRESOLVED | — |
| Estrogen Receptor Negative | — | UNRESOLVED | — |
| HER2/Neu Negative | — | UNRESOLVED | — |
| MLH1 Gene Mutation | — | UNRESOLVED | — |
| MSH2 Gene Mutation | — | UNRESOLVED | — |
| MSH6 Gene Mutation | — | UNRESOLVED | — |
| PALB2 Gene Mutation | — | UNRESOLVED | — |
| PMS2 Gene Mutation | — | UNRESOLVED |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Educational Intervention | Other | — | UNRESOLVED |
| Genetic Counseling | Other | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * Age 30 or older. Note: Participants must meet each of Criteria 1-4. * Have access to a healthcare provider and be willing to share genetic results with that provider * Have at least one ovary * Have a valid United States mailing address for receipt of saliva kit * Participants must meet any one of the following 6 criteria: * Diagnosed with breast cancer at age 45 or younger * 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 * Have one blood relative with a mutation in BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, BARD1, MSH2, MSH6, MLH1, or PMS2 * Have one relative with ovarian cancer * Have at least 2 relatives with breast cancer on the same side of the family, one of which is =\< 50 years of age * Have one male relative with breast cancer Exclusion Criteria: * Personal history of ovarian cancer * Unable to read, speak, and understand English * Unable to provide informed consent * Unwilling to complete baseline and follow-up questionnaires * Unable to access the internet * Previous genetic testing or counseling regarding cancer risk * Previous bone marrow transplant * Previous blood transfusion (7 days prior to genetic testing) * Active hematologic malignancy (cancer that begins in blood-forming tissue, such as leukemia or lymphoma)
References
Publications (3)
- DERIVEDSwisher 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 37707822
- DERIVEDCoffin 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 36155347
- DERIVEDRayes 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. PMID 31266460