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

  • STATUS
    Recruiting
  • End date
    Apr 18, 2022
  • participants needed
    4000
  • sponsor
    M.D. Anderson Cancer Center
Updated on 23 January 2021
cancer
estrogen
breast cancer
progesterone
epidermal growth factor receptor
biomarker analysis
human epidermal growth factor
genetic counseling
triple negative breast cancer
ovarian cancer
progesterone receptor
estrogen receptor
genetic testing
educational intervention
palb2
rad51c

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.

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.

Details
Condition Estrogen Receptor Negative, Progesterone Receptor Negative, PALB2 Gene Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation, BRCA2 Mutation, Candidates for BRCA 1/2 Testing, BARD1 Gene Mutation, BRIP1 Gene Mutation, MLH1 Gene Mutation, MSH2 Gene Mutation, MSH6 Gene Mutation, PMS2 Gene Mutation, Candidates for BRCA 1/2 Testing, Candidates for BRCA 1/2 Testing, Candidates for BRCA 1/2 Testing, HER2/Neu Negative, RAD51C Gene Mutation, RAD51D Gene Mutation, Triple-Negative Breast Carcinoma, HER2/Neu Negative, Triple-Negative Breast Carcinoma, HER2/Neu Negative, Triple-Negative Breast Carcinoma, Triple Negative Breast Carcinoma, msh2 mutation, HER2/Neu Negative
Treatment laboratory biomarker analysis, questionnaire administration, educational intervention, Questionnaires, Genetic Counseling, Saliva collection, Genetic Video, Genetic Counselor, Genetic Testing Results
Clinical Study IdentifierNCT02993068
SponsorM.D. Anderson Cancer Center
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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