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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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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, BARD1 Gene Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation, BRIP1 Gene Mutation

Intervention / Treatment
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* Other: Educational Intervention
* Other: Genetic Counseling
* Other: Genetic Counseling
* Other: Laboratory Biomarker Analysis
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A (online education)<br>Patients watch genetic testing online educational video and receive genetic testing online test results report. | Other: Educational Intervention<br>* Watch genetic testing online educational video<br>* Other names: Intervention, Educational;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Arm B (online education, post telephone counseling)<br>Patients watch genetic testing online educational video, receive genetic testing online test results report, and post-telephone genetic counseling. | Other: Educational Intervention<br>* Watch genetic testing online educational video<br>* Other names: Intervention, Educational;Other: Genetic Counseling<br>* Receive post-telephone genetic counseling<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Arm C (online education, pre- and post-telephone counselling)<br>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<br>* Watch genetic testing online educational video<br>* Other names: Intervention, Educational;Other: Genetic Counseling<br>* Receive post-telephone genetic counseling<br>Other: Genetic Counseling<br>* Receive pre-telephone genetic counseling<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Arm D (online education, pre-telephone counseling)<br>Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, and genetic testing online test results report. | Other: Educational Intervention<br>* Watch genetic testing online educational video<br>* Other names: Intervention, Educational;Other: Genetic Counseling<br>* Receive pre-telephone genetic counseling<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean cancer stress scores | Mean cancer stress scores are measured on the Impact of Events Scale (IES), a 15-item self-report measure that assesses subjective distress caused by traumatic events, which may include a positive genetic test result.There are two subscales, Intrusion and Avoidance, used to calculate a total. The range for Intrusion is 0-35 and the range for Avoidance is 0-40. The range of the total score is 0-75. Higher scores reflect more stressful impact, and therefore, a worse outcome. Subscales are summed to compute the total score. | Up to 4 years |