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

NCT02993068 | Suspended

• 2 other identifiers: 2016-0298NCI-2017-01600
• Study Type: interventional
• Target: 5,200
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Arm A (online education)

EXPERIMENTAL

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

Other: Educational Intervention; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration

Arm B (online education, post telephone counseling)

EXPERIMENTAL

Patients watch genetic testing online educational video, receive genetic testing online test results report, and post-telephone genetic counseling.

Other: Educational Intervention; Other: Genetic Counseling; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration

Arm C (online education, pre- and post-telephone counselling)

ACTIVE COMPARATOR

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; Other: Genetic Counseling; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration

Arm D (online education, pre-telephone counseling)

EXPERIMENTAL

Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, and genetic testing online test results report.

Other: Educational Intervention; Other: Genetic Counseling; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration

Interventions

Educational Intervention OTHER

Watch genetic testing online educational video

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Arm A (online education); Arm B (online education, post telephone counseling); Arm C (online education, pre- and post-telephone counselling); Arm D (online education, pre-telephone counseling)

Genetic Counseling OTHER

Receive post-telephone genetic counseling

Arm B (online education, post telephone counseling); Arm C (online education, pre- and post-telephone counselling)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm A (online education); Arm B (online education, post telephone counseling); Arm C (online education, pre- and post-telephone counselling); Arm D (online education, pre-telephone counseling)

Questionnaire Administration OTHER

Ancillary studies

Arm A (online education); Arm B (online education, post telephone counseling); Arm C (online education, pre- and post-telephone counselling); Arm D (online education, pre-telephone counseling)

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Related Publications (3)

• Swisher EM, Rayes N, Bowen D, Peterson CB, Norquist BM, Coffin T, Gavin K, Polinsky D, Crase J, Bakkum-Gamez JN, Blank SV, Munsell MF, Nebgen D, Fleming GF, Olopade OI, Law S, Zhou A, Levine DA, D'Andrea A, Lu KH. Remotely Delivered Cancer Genetic Testing in the Making Genetic Testing Accessible (MAGENTA) Trial: A Randomized Clinical Trial. JAMA Oncol. 2023 Nov 1;9(11):1547-1555. doi: 10.1001/jamaoncol.2023.3748.

  PMID: 37707822 DERIVED

• Coffin T, Bowen D, Lu K, Swisher EM, Rayes N, Norquist B, Blank SV, Levine DA, Bakkum-Gamez JN, Fleming GF, I Olopade O, Romero I, D'Andrea A, Nebgen DR, Peterson C, Munsell MF, Gavin K, Crase J, Polinsky D, Lechner R. Using Social Media to Facilitate Communication About Women's Testing: Tool Validation Study. JMIR Form Res. 2022 Sep 26;6(9):e35035. doi: 10.2196/35035.

  PMID: 36155347 DERIVED

• 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. MAGENTA (Making Genetic testing accessible): a prospective randomized controlled trial comparing online genetic education and telephone genetic counseling for hereditary cancer genetic testing. BMC Cancer. 2019 Jul 2;19(1):648. doi: 10.1186/s12885-019-5868-x.

  PMID: 31266460 DERIVED

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Early Intervention, Educational; Educational Status; Methods; Genetic Counseling

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Genetic Services

Study Officials

• Roni Wilke

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 14, 2016
• Study Start: April 18, 2017
• Primary Completion: April 18, 2026
• Study Completion: April 18, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (2)