Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible)
Status: | Recruiting |
---|---|
Conditions: | Breast Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 30 - Any |
Updated: | 4/17/2018 |
Start Date: | April 18, 2017 |
End Date: | April 2022 |
Contact: | Karen H. Lu, MD |
Email: | magenta@mdanderson.org |
Phone: | 713-745-7877 |
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
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
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.
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.
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)
We found this trial at
3
sites
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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New York University School of Medicine NYU School of Medicine has a proud history that...
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