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

Conditions

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

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.

Detailed 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.

Elizabeth M. Swisher, Nadine Rayes, Deborah J. Bowen, Christine B. Peterson, Barbara M. Norquist et al. (20 authors)

JAMA Oncology2023-09-1443 citations

10.1001/jamaoncol.2023.3748

Using Social Media to Facilitate Communication About Women’s Testing: Tool Validation Study

Tara B. Coffin, Deborah J. Bowen, Karen H. Lu, Elizabeth M. Swisher, Nadine Rayes et al. (20 authors)

JMIR Formative Research2022-03-166 citations

10.2196/35035

Results from MAGENTA: A national randomized four-arm noninferiority trial evaluating pre- and post-test genetic counseling during online testing for breast and ovarian cancer genetic risk.

Elizabeth M. Swisher, Nadine Rayes, Deborah J. Bowen, Christine B. Peterson, Tara B. Coffin et al. (20 authors)

Journal of Clinical Oncology2020-05-2019 citations

10.1200/jco.2020.38.15_suppl.1506

MAGENTA (Making Genetic testing accessible): a prospective randomized controlled trial comparing online genetic education and telephone genetic counseling for hereditary cancer genetic testing.

Rayes N, Bowen DJ, Coffin T, Nebgen D, Peterson C, Munsell MF, Gavin K, Lechner R, Crase J, Polinsky D, Romero I, Blank SV, Levine DA, Norquist BM, Swisher EM, Lu KH.

2019-07-0229 citations

10.1186/s12885-019-5868-x

Interventions

OTHEREducational Intervention

Watch genetic testing online educational video

OTHERGenetic Counseling

Receive post-telephone genetic counseling

OTHERLaboratory Biomarker Analysis

Correlative studies

OTHERQuestionnaire Administration

Ancillary studies

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

30 Years to No maximum

Healthy volunteers

No

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)

Design outcomes

Primary

Measure	Time frame	Description
Mean cancer stress scores	Up to 4 years	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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRoni Wilke

M.D. Anderson Cancer Center

Outcome results

None listed