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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02993068
Recruitment Status : Recruiting
First Posted : December 14, 2016
Last Update Posted : May 16, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE December 7, 2016
First Posted Date  ICMJE December 14, 2016
Last Update Posted Date May 16, 2019
Actual Study Start Date  ICMJE April 18, 2017
Estimated Primary Completion Date April 18, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
Mean cancer stress scores [ Time Frame: Up to 4 years ]
Will construct 99.17% one-sided confidence intervals for differences in mean cancer stress scores for study Arms A, B, and D compared with study Arm C within risk group 1.
Original Primary Outcome Measures  ICMJE
 (submitted: December 12, 2016)
Effects of Online Genetic Education Versus Telephone Genetic Counseling on Cancer-Risk Distress [ Time Frame: 3 months after receiving genetic test results ]
Stress about the risk of getting cancer measured with the Impact of Event Scale (IES) (Horowitz et al. 1979).
Change History Complete list of historical versions of study NCT02993068 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2016)
Completion Rate [ Time Frame: 3 months after receiving genetic test results ]
Completion rate defined as a participant progressing through the entire process from pre- genetic testing education/counseling to receiving test results and post- genetic testing education/counseling.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible)
Official Title  ICMJE Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible)
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:

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  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • 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
Intervention  ICMJE
  • 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
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Other: Questionnaire Administration
    Ancillary studies
Study Arms  ICMJE
  • Experimental: Arm A (online education)
    Patients watch genetic testing online educational video and receive genetic testing online test results report.
    Interventions:
    • Other: Educational Intervention
    • Other: Laboratory Biomarker Analysis
    • Other: Questionnaire Administration
  • 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.
    Interventions:
    • Other: Educational Intervention
    • Other: Genetic Counseling
    • Other: Laboratory Biomarker Analysis
    • Other: Questionnaire Administration
  • 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.
    Interventions:
    • Other: Educational Intervention
    • Other: Genetic Counseling
    • Other: Genetic Counseling
    • Other: Laboratory Biomarker Analysis
    • Other: Questionnaire Administration
  • 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.
    Interventions:
    • Other: Educational Intervention
    • Other: Genetic Counseling
    • Other: Laboratory Biomarker Analysis
    • Other: Questionnaire Administration
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 14, 2019)
4000
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2016)
3000
Estimated Study Completion Date  ICMJE April 18, 2022
Estimated Primary Completion Date April 18, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Karen H. Lu, MD 713-745-7877 magenta@mdanderson.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02993068
Other Study ID Numbers  ICMJE 2016-0298
NCI-2017-01600 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-0298 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Karen H Lu M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP