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

HER2/Neu Negative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02993068
• Other study ID #: 2016-0298
• Secondary ID: NCI-2017-0160020
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2017
• Est. completion date: April 18, 2024

Study information

• Verified date: January 2024
• Source: M.D. Anderson Cancer Center
• Contact: Karen H. Lu, MD
• Phone: 713-745-7877
• Email: magenta[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5200
• Est. completion date: April 18, 2024
• Est. primary completion date: April 18, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• BARD1 Gene Mutation
• BRCA1 Gene Mutation
• BRCA2 Gene Mutation
• Breast Neoplasms
• 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

Intervention

Other:
• Educational Intervention
Watch genetic testing online educational video
• Genetic Counseling
Receive post-telephone genetic counseling
• Genetic Counseling
Receive pre-telephone genetic counseling
• Laboratory Biomarker Analysis
Correlative studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   MD Anderson Cancer Center