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

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.

Study Overview

• Status: Recruiting
• Conditions: BRCA1 Gene Mutation; BRCA2 Gene Mutation; Estrogen Receptor Negative; HER2/Neu Negative; Progesterone Receptor Negative; Triple-Negative Breast Carcinoma; MLH1 Gene Mutation; RAD51C Gene Mutation; RAD51D Gene Mutation; BRIP1 Gene Mutation; PALB2 Gene Mutation; BARD1 Gene Mutation; MSH2 Gene Mutation; MSH6 Gene Mutation; PMS2 Gene Mutation
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Other: Educational Intervention; Other: Genetic Counseling; Other: Genetic Counseling

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 5200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karen H. Lu, MD; Phone Number: 713-745-7877; Email: magenta@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Karen H. Lu; Phone Number: 713-745-8902
      • Principal Investigator: Karen H. Lu
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington Medical Center
      • Contact: Elizabeth M. Swisher; Email: swishere@u.washington.edu
      • Principal Investigator: Elizabeth M. Swisher

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A (online education); Patients watch genetic testing online educational video and receive genetic testing online test results report.	Other: Laboratory Biomarker Analysis; Correlative studies; Other: Questionnaire Administration; Ancillary studies; Other: Educational Intervention; Watch genetic testing online educational video; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational
Experimental: 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.	Other: Laboratory Biomarker Analysis; Correlative studies; Other: Questionnaire Administration; Ancillary studies; Other: Educational Intervention; Watch genetic testing online educational video; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Genetic Counseling; Receive post-telephone genetic counseling; Other: Genetic Counseling; Receive pre-telephone genetic counseling
Active Comparator: 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.	Other: Laboratory Biomarker Analysis; Correlative studies; Other: Questionnaire Administration; Ancillary studies; Other: Educational Intervention; Watch genetic testing online educational video; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Genetic Counseling; Receive post-telephone genetic counseling; Other: Genetic Counseling; Receive pre-telephone genetic counseling
Experimental: 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.	Other: Laboratory Biomarker Analysis; Correlative studies; Other: Questionnaire Administration; Ancillary studies; Other: Educational Intervention; Watch genetic testing online educational video; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Genetic Counseling; Receive post-telephone genetic counseling; Other: Genetic Counseling; Receive pre-telephone genetic counseling

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Karen H Lu, M.D. Anderson Cancer Center

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2017
• Primary Completion (Estimated): April 18, 2024
• Study Completion (Estimated): April 18, 2024

Study Registration Dates

• First Submitted: December 7, 2016
• First Submitted That Met QC Criteria: December 12, 2016
• First Posted (Estimated): December 14, 2016

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2016-0298 (Other Identifier: M D Anderson Cancer Center); NCI-2017-01600 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No