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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

5200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-18

Study Completion Date

2026-04-18

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.

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Detailed Description

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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

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Arm A (online education)

Patients watch genetic testing online educational video and receive genetic testing online test results report.

Group Type EXPERIMENTAL

Educational Intervention

Intervention Type OTHER

Watch genetic testing online educational video

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type EXPERIMENTAL

Educational Intervention

Intervention Type OTHER

Watch genetic testing online educational video

Genetic Counseling

Intervention Type OTHER

Receive post-telephone genetic counseling

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type ACTIVE_COMPARATOR

Educational Intervention

Intervention Type OTHER

Watch genetic testing online educational video

Genetic Counseling

Intervention Type OTHER

Receive post-telephone genetic counseling

Genetic Counseling

Intervention Type OTHER

Receive pre-telephone genetic counseling

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type EXPERIMENTAL

Educational Intervention

Intervention Type OTHER

Watch genetic testing online educational video

Genetic Counseling

Intervention Type OTHER

Receive pre-telephone genetic counseling

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Educational Intervention

Watch genetic testing online educational video

Intervention Type OTHER

Genetic Counseling

Receive post-telephone genetic counseling

Intervention Type OTHER

Genetic Counseling

Receive pre-telephone genetic counseling

Intervention Type OTHER

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Education for Intervention Intervention by Education Intervention through Education Intervention, Educational

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)

Minimum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No