NCT02993068

Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible)

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 5,200 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: 1\. To test the effects of online genetic education versus telephone genetic counseling on cancer-risk distress. SECONDARY OBJECTIVES: 1. To test the effects of online genetic education versus telephone genetic counseling on testing completion rates. 2. To evaluate the role of psychological and social variables in women's reactions to genetic testing for ovarian cancer risk with variable education strategies. 3. To consider the effects of variations of genetic education/counseling on genetic knowledge, satisfaction with the decision to undergo testing, and family communication. 4. To examine the cancer screening and prevention behaviors, as well as cascade testing behaviors among patients who tested positive for a pathogenic variant. 5. To determine factors contributing to non-completion of genetic testing in subjects enrolled in a genetic testing trial. 6. To determine the impact of pre- and/or post-test genetic counseling on family communication, genetic testing concerns and screening behaviors. 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.

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

Interventions

Type	Name	Description
OTHER	Educational Intervention	Watch genetic testing online educational video
OTHER	Genetic Counseling	Receive post-telephone genetic counseling
OTHER	Genetic Counseling	Receive pre-telephone genetic counseling
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2017-04-18
• Primary completion: 2026-04-18
• Completion: 2026-04-18
• First posted: 2016-12-14
• Last updated: 2026-02-19

Locations

2 sites across 1 country: United States