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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.

  Hide Detailed Description

Detailed Description:

Study Groups:

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 participant is eligible to take part in this study and participant agrees to take part in this study, participant 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 participant tests positive for a genetic mutation, participant will be prompted to speak to a genetic counselor, no matter which group participant is assigned. A study genetic counselor will be available to speak to participant if participant desires, regardless of the study group participant is in.

Informed Consent Comprehension Questions:

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

Baseline Questionnaire:

If participant is approved to sign this informed consent based on the results of the above informed consent questions, participant 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 participant can access from participant's phone, tablet, or computer. These will include questions about decision-making, stress and anxiety, participant's well-being, and participant's genetic and cancer- risk knowledge. The questionnaires will take about 20 minutes to complete. Participant 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, participant will receive an e-mail to connect participant to the website for Color Genomics, the company that will provide the genetic testing services for this study.
  • Participant 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, participant will be directed to create a personal Color Genomics account that will allow participant to enter participant's personal and family history information, keep track of participant's genetic testing kit, and receive participant's genetic test results. Participant will provide participant's contact information (including shipping address), as well as the name and contact information for participant's local doctor. Any and all information participant provides 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.
  • Participant 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 co-investigator on this study.When participant receives it in the mail, participant will use the kit's unique barcode number to activate it and link it to participant's online account. A video on the website will show participant how to provide a large enough saliva sample. It will also contain instructions for how to properly package and mail participant's 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. Participant will receive an email, letting participant know that participant's results are available for review through participant's 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 participant will be given the option to speak to a genetic counselor if participant would like. Participant may be given contact information for a local genetic counselor.

Depending on the results of participant's genetic testing, the study staff may attempt to schedule a post-test telephone genetic counseling call 3 times. If participant does 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.

Participant will also be given the option to schedule a phone call with a genetic counselor on the Color Genomics website if participant wants to speak to a genetic counselor at any point during the study.

Participant's genetic test results will be shared with the MD Anderson research team.

Follow-up Questionnaires:

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

Length of Study:

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

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

  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