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

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ClinicalTrials.gov Identifier: NCT02993068
Recruitment Status : Recruiting
First Posted : December 14, 2016
Last Update Posted : May 16, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
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 Other: Educational Intervention Other: Genetic Counseling Other: Laboratory Biomarker Analysis Other: Questionnaire Administration Early Phase 1

Detailed Description:

PRIMARY OBJECTIVES:

I. To test the effects of online genetic education versus telephone genetic counseling on cancer-risk distress.

SECONDARY OBJECTIVES:

I. To test the effects of online genetic education versus telephone genetic counseling on testing completion rates.

II. To evaluate the role of psychological and social variables in women's reactions to genetic testing for ovarian cancer risk with variable education strategies.

III. To consider the effects of variations of genetic education/counseling on genetic knowledge, satisfaction with the decision to undergo testing, and family communication.

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible)
Actual Study Start Date : April 18, 2017
Estimated Primary Completion Date : April 18, 2021
Estimated Study Completion Date : April 18, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genetic Testing

Arm Intervention/treatment
Experimental: Arm A (online education)
Patients watch genetic testing online educational video and receive genetic testing online test results report.
Other: Educational Intervention
Watch genetic testing online educational video
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Questionnaire Administration
Ancillary studies

Experimental: Arm B (online education, post telephone counseling)
Patients watch genetic testing online educational video, receive genetic testing online test results report, and post-telephone genetic counseling.
Other: Educational Intervention
Watch genetic testing online educational video
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

Other: Genetic Counseling
Receive post-telephone genetic counseling

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Questionnaire Administration
Ancillary studies

Active Comparator: Arm C (online education, pre- and post-telephone counselling)
Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, genetic testing online test results report, and post-telephone genetic counseling.
Other: Educational Intervention
Watch genetic testing online educational video
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

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

Experimental: Arm D (online education, pre-telephone counseling)
Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, and genetic testing online test results report.
Other: Educational Intervention
Watch genetic testing online educational video
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

Other: Genetic Counseling
Receive pre-telephone genetic counseling

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Mean cancer stress scores [ Time Frame: Up to 4 years ]
    Will construct 99.17% one-sided confidence intervals for differences in mean cancer stress scores for study Arms A, B, and D compared with study Arm C within risk group 1.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02993068


Contacts
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Contact: Karen H. Lu, MD 713-745-7877 magenta@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Karen H. Lu    713-745-8902      
Principal Investigator: Karen H. Lu         
United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Elizabeth M. Swisher       swishere@u.washington.edu   
Principal Investigator: Elizabeth M. Swisher         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Karen H Lu M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02993068     History of Changes
Other Study ID Numbers: 2016-0298
NCI-2017-01600 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-0298 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases