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

Last updated: February 10, 2025
Sponsor: M.D. Anderson Cancer Center
Overall Status: Suspended

Phase

N/A

Condition

Metastatic Triple-negative Breast Cancer

Treatment

Laboratory Biomarker Analysis

Genetic Counseling

Educational Intervention

Clinical Study ID

NCT02993068
2016-0298
P30CA016672
2016-0298
NCI-2017-01600
  • Ages > 30
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 withthat 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, progesteronereceptor and not human epidermal growth factor receptor 2 [Her2] amplified) breastcancer 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 ofwhich is =< 50 years of age

  • Have one male relative with breast cancer

Exclusion

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 asleukemia or lymphoma)

Study Design

Total Participants: 5200
Treatment Group(s): 4
Primary Treatment: Laboratory Biomarker Analysis
Phase:
Study Start date:
April 18, 2017
Estimated Completion Date:
April 18, 2026

Study 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.

Connect with a study center

  • New York University School of Medicine

    New York, New York 10016
    United States

    Site Not Available

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Washington Medical Center

    Seattle, Washington 98195
    United States

    Site Not Available

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