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

This study is currently recruiting participants.
Verified August 2017 by M.D. Anderson Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02993068
First Posted: December 14, 2016
Last Update Posted: August 22, 2017
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.
Collaborator:
Stand Up To Cancer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose

The goal of this research study is to test the effects of online genetic education alone or in combination with telephone genetic counseling in order to compare the two methods and the stress a person feels about their risk of cancer.

Researchers also want to learn how these strategies may improve participant's understanding of genetics, participant's ability to complete a quiz about genetics, and participant's quality of life.

URL: https://magenta.mdanderson.org


Condition Intervention
Candidates for BRCA 1/2 Testing Behavioral: Questionnaires Behavioral: Genetic Video Behavioral: Genetic Counselor Genetic: Saliva Collection Behavioral: Genetic Counseling Behavioral: Genetic Testing Results

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 3000
Actual Study Start Date: April 18, 2017
Estimated Study Completion Date: April 2021
Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
Arm A: Pre- genetic testing online educational video and post- genetic testing online test results report with approximately 750 participants.
Behavioral: Questionnaires

Baseline questionnaires about decision-making, stress and anxiety, well-being, and genetic and cancer- risk knowledge.

Follow up questionnaires completed at 3 months, 1 year, and 2 years after having received the genetic test results.

Other Name: Surveys
Behavioral: Genetic Video
Participants watch a welcome video, which will provide information about genetics, the genes and genetic mutations that will be tested, and possible test results.
Genetic: Saliva Collection
Participants mailed an FDA-approved saliva collection kit from Color Genomics. A video on the website shows participant how to provide a large enough saliva sample.
Behavioral: Genetic Testing Results
Participants in Groups B and C need to make an appointment with a genetic counselor before viewing the genetic test results. Participants in Groups A and D are able to view results online without speaking to a genetic counselor, but will be given the option to speak to a genetic counselor if participant would like.
Experimental: Arm B
Arm B: Pre- genetic testing online educational video and post- genetic testing online test results report with telephone genetic counseling with approximately 750 participants.
Behavioral: Questionnaires

Baseline questionnaires about decision-making, stress and anxiety, well-being, and genetic and cancer- risk knowledge.

Follow up questionnaires completed at 3 months, 1 year, and 2 years after having received the genetic test results.

Other Name: Surveys
Behavioral: Genetic Video
Participants watch a welcome video, which will provide information about genetics, the genes and genetic mutations that will be tested, and possible test results.
Behavioral: Genetic Counselor
Participants in Group C and Group D make an appointment with a genetic counselor before beginning the genetic testing process. Participants in Groups A and B provided with the option to speak to a genetic counselor if they want to, but will not be required to do so for this study.
Genetic: Saliva Collection
Participants mailed an FDA-approved saliva collection kit from Color Genomics. A video on the website shows participant how to provide a large enough saliva sample.
Behavioral: Genetic Counseling
Participants in Groups B and C need to make an appointment with a genetic counselor before viewing the genetic test results. Participants in Groups A and D are able to view results online without speaking to a genetic counselor, but will be given the option to speak to a genetic counselor if participant would like.
Behavioral: Genetic Testing Results
Participants in Groups B and C need to make an appointment with a genetic counselor before viewing the genetic test results. Participants in Groups A and D are able to view results online without speaking to a genetic counselor, but will be given the option to speak to a genetic counselor if participant would like.
Arm C
Arm C: Pre- genetic testing online educational video with telephone genetic counseling and online test results report with telephone genetic counseling with approximately 750 participants.
Behavioral: Questionnaires

Baseline questionnaires about decision-making, stress and anxiety, well-being, and genetic and cancer- risk knowledge.

Follow up questionnaires completed at 3 months, 1 year, and 2 years after having received the genetic test results.

Other Name: Surveys
Behavioral: Genetic Video
Participants watch a welcome video, which will provide information about genetics, the genes and genetic mutations that will be tested, and possible test results.
Behavioral: Genetic Counselor
Participants in Group C and Group D make an appointment with a genetic counselor before beginning the genetic testing process. Participants in Groups A and B provided with the option to speak to a genetic counselor if they want to, but will not be required to do so for this study.
Genetic: Saliva Collection
Participants mailed an FDA-approved saliva collection kit from Color Genomics. A video on the website shows participant how to provide a large enough saliva sample.
Behavioral: Genetic Counseling
Participants in Groups B and C need to make an appointment with a genetic counselor before viewing the genetic test results. Participants in Groups A and D are able to view results online without speaking to a genetic counselor, but will be given the option to speak to a genetic counselor if participant would like.
Behavioral: Genetic Testing Results
Participants in Groups B and C need to make an appointment with a genetic counselor before viewing the genetic test results. Participants in Groups A and D are able to view results online without speaking to a genetic counselor, but will be given the option to speak to a genetic counselor if participant would like.
Experimental: Arm D
Arm D: Pre- genetic testing educational video with telephone genetic counseling and post- genetic testing online test results report with approximately 750 participants.
Behavioral: Questionnaires

Baseline questionnaires about decision-making, stress and anxiety, well-being, and genetic and cancer- risk knowledge.

Follow up questionnaires completed at 3 months, 1 year, and 2 years after having received the genetic test results.

Other Name: Surveys
Behavioral: Genetic Video
Participants watch a welcome video, which will provide information about genetics, the genes and genetic mutations that will be tested, and possible test results.
Genetic: Saliva Collection
Participants mailed an FDA-approved saliva collection kit from Color Genomics. A video on the website shows participant how to provide a large enough saliva sample.
Behavioral: Genetic Testing Results
Participants in Groups B and C need to make an appointment with a genetic counselor before viewing the genetic test results. Participants in Groups A and D are able to view results online without speaking to a genetic counselor, but will be given the option to speak to a genetic counselor if participant would like.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 30 or older Note: Participants must meet each of Criteria 1-4.
  2. Have access to a healthcare provider and be willing to share genetic results with that provider
  3. Have at least one ovary
  4. Have a valid United States mailing address for receipt of saliva kit
  5. Diagnosed with breast cancer at age 45 or younger Note: Participants must also meet any one of Criteria 5-10.
  6. 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
  7. Have one blood relative with a mutation in BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, BARD1, MSH2, MSH6, MLH1, or PMS2
  8. Have one relative with ovarian cancer
  9. Have at least 2 relatives with breast cancer on the same side of the family, one of which is </= 50 years of age
  10. Have one male relative with breast cancer

Exclusion Criteria:

  1. Personal history of ovarian cancer
  2. Unable to read, speak, and understand English
  3. Unable to provide informed consent
  4. Unwilling to complete baseline and follow-up questionnaires
  5. Unable to access the internet
  6. Previous genetic testing or counseling regarding cancer risk
  7. Previous bone marrow transplant
  8. Previous blood transfusion (7 days prior to genetic testing)
  9. Active hematologic malignancy (cancer that begins in blood-forming tissue, such as leukemia or lymphoma)
  10. Residents of the state of New York
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02993068


Contacts
Contact: Karen H. Lu, MD 713-745-7877 magenta@mdanderson.org

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact       magenta@mdanderson.org/   
Sponsors and Collaborators
M.D. Anderson Cancer Center
Stand Up To Cancer
Investigators
Principal Investigator: Karen H. Lu, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02993068     History of Changes
Other Study ID Numbers: 2016-0298
SU2C-AACR-DT16-15 ( Other Grant/Funding Number: Stand Up To Cancer )
First Submitted: December 7, 2016
First Posted: December 14, 2016
Last Update Posted: August 22, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Genetic testing
Genetic educational video
Genetic counseling
Online genetic test results
Telephone genetic counseling
Saliva test
Questionnaires
Surveys