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

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ClinicalTrials.gov Identifier: NCT02993068
Recruitment Status : Recruiting
First Posted : December 14, 2016
Last Update Posted : April 9, 2018
Sponsor:
Collaborator:
Stand Up To Cancer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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 your understanding of genetics, your ability to complete a quiz about genetics, and your quality of life.

This is an investigational study. The saliva-testing kit and genetic testing done in this study is FDA approved and will be processed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.

Up to 3000 participants will be enrolled in this study.

URL: https://magenta.mdanderson.org


Condition or disease Intervention/treatment Phase
Candidates for BRCA 1/2 Testing Behavioral: Questionnaires Behavioral: Genetic Video Behavioral: Genetic Counselor Genetic: Saliva Collection Behavioral: Genetic Counseling Behavioral: Genetic Testing Results Not Applicable

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Detailed Description:

Support and education about genetic testing is usually given before and after genetic testing is done. Researchers in this study will look at how combining different interventions before and after testing may help participants improve understanding.

If you are eligible to take part in this study and you agree to take part in this study, you will be randomly assigned (as in the roll of the dice) to 1 of 4 study groups:

  • Participants in Group A will watch an online educational video before the testing, and receive an online test results report after the testing.
  • Participants in Group B will watch an online educational video before the testing, and receive an online test results report with telephone genetic counseling after the testing.
  • Participants in Group C will watch an online educational video with telephone genetic counseling before the testing, and receive an online test results report with telephone genetic counseling after the testing.
  • Participants in Group D will watch an online educational video with telephone genetic counseling before the testing, and receive an online test results report after the testing.

Please note that if you test positive for a genetic mutation, you will be prompted to speak to a genetic counselor, no matter which group you are assigned. A study genetic counselor will be available to speak to you if you desire, regardless of the study group you are in.

Informed Consent Comprehension Questions:

After reading this informed consent, you will be asked 5 questions about the information in this informed consent to help ensure that you have understood this information. You must answer those questions correctly in order to electronically sign this consent and begin the study.

Baseline Questionnaire:

If you are approved to sign this informed consent based on the results of the above informed consent questions, you will receive an e-mail with a link to complete the baseline questionnaire. All questionnaires will be completed through REDCap, a secure, web-based application used to collect data for research studies that you can access from your phone, tablet, or computer. These will include questions about decision-making, stress and anxiety, your well-being, and your genetic and cancer- risk knowledge. The questionnaires will take about 20 minutes to complete. You must complete these questionnaires in order to move on to the next part of the study.

The Genetic Testing and Counseling/Education Process:

  • After completing the baseline questionnaires, you will receive an e-mail to connect you to the website for Color Genomics, the company that will provide the genetic testing services for this study.
  • You will watch a welcome video, which will provide information about genetics, the genes and genetic mutations that will be tested, and possible test results.
  • After watching the welcome video, you will be directed to create a personal Color Genomics account that will allow you to enter your personal and family history information, keep track of your genetic testing kit, and receive your genetic test results. You will provide your contact information (including shipping address), as well as the name and contact information for your local doctor. Any and all information you provide to Color Genomics will be shared with the MD Anderson research team.
  • Participants in Group C and Group D will then make an appointment with a genetic counselor before beginning the genetic testing process. Participants in Groups A and B will be 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.
  • You will be mailed an FDA-approved saliva collection kit from Color Genomics, which will be ordered by Dr. Elizabeth Swisher (a gynecologic oncologist at the University of Washington and study co-investigator) or Dr. Douglas Levine (a gynecologic oncologist at NYU Langone Health and study collaborator). When you receive it in the mail, you will use the kit's unique barcode number to activate it and link it to your online account. A video on the website will show you how to provide a large enough saliva sample. It will also contain instructions for how to properly package and mail your kit back to Color Genomics, using a pre-paid shipping package.

Getting the Test Results:

It usually takes about 6-8 weeks to get the results back from this genetic test. You will receive an email, letting you know that your results are available for review through your Color Genomics account.

Genetic Counseling:

Participants in Groups B and C will need to make an appointment with a genetic counselor before viewing the genetic test results. Participants in Groups A and D will be able to view their results online without speaking to a genetic counselor, but you will be given the option to speak to a genetic counselor if you would like. You may be given contact information for a local genetic counselor.

Depending on the results of your genetic testing, the study staff may attempt to schedule a post-test telephone genetic counseling call 3 times. If you do not respond to the study staff to schedule the call within 1 week after the third attempt, the study staff will deliver the results online with a note to please call and schedule a counseling session. You will also be given the option to schedule a phone call with a genetic counselor on the Color Genomics website if you want to speak to a genetic counselor at any point during the study. Your genetic test results will be shared with the MD Anderson research team.

Follow-up Questionnaires:

You will be contacted by e-mail to complete quality-of-life questionnaires at 3 time- points. You will be asked to complete the questionnaires through the REDCap online database at 3 months, 1 year, and 2 years after having received your genetic test results. The questionnaires should be completed within 1 month (for the first one) or 3 months (for the other two) after you receive the email. You will be sent reminder emails if these questionnaires have not been completed in time. It should take you no more than 20 minutes to complete each questionnaire.

Other Information Color Genomics (referred to as "Color" throughout this paragraph) offers the option of consenting to storing your sample and DNA (genetic material), commonly referred to as DNA bio-banking, at Color's expense to allow you to have additional testing through Color in the future. If you choose to allow Color to store your sample, Color may store your sample indefinitely (forever), but you may remove your sample from storage by updating your own account settings. Your participation in Color Genomics' DNA storage will not affect your participation in this research study, and your decision for this option will be decided when you consent to genetic testing with Color Genomics (the testing laboratory). Data involving this optional procedure will not be shared with MD Anderson. MD Anderson will not have oversight over your samples stored at Color Genomics.

Length of Study:

Your total participation on this study will last about 2 years, including follow-up. You may be contacted regarding participation in future studies.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible)
Actual Study Start Date : April 18, 2017
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 :
  1. 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.



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, Older Adult)
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)

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, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Douglas Levine, MD         
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact       magenta@mdanderson.org/   
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Elizabeth Swisher, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Stand Up To Cancer
Investigators
Principal Investigator: Karen H. Lu, MD M.D. Anderson Cancer Center

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 Posted: December 14, 2016    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018

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