Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-02-20 @ 6:34 PM
Study NCT ID:
NCT02993068
Status:
SUSPENDED
Last Update Posted:
2025-08-17
First Post:
2016-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible)
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible)
Status:
SUSPENDED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Accrual Limit
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
1\. To test the effects of online genetic education versus telephone genetic counseling on cancer-risk distress.
SECONDARY OBJECTIVES:
1. To test the effects of online genetic education versus telephone genetic counseling on testing completion rates.
2. To evaluate the role of psychological and social variables in women's reactions to genetic testing for ovarian cancer risk with variable education strategies.
3. To consider the effects of variations of genetic education/counseling on genetic knowledge, satisfaction with the decision to undergo testing, and family communication.
4. To examine the cancer screening and prevention behaviors, as well as cascade testing behaviors among patients who tested positive for a pathogenic variant.
5. To determine factors contributing to non-completion of genetic testing in subjects enrolled in a genetic testing trial.
6. To determine the impact of pre- and/or post-test genetic counseling on family communication, genetic testing concerns and screening behaviors.
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.
1\. To test the effects of online genetic education versus telephone genetic counseling on cancer-risk distress.
SECONDARY OBJECTIVES:
1. To test the effects of online genetic education versus telephone genetic counseling on testing completion rates.
2. To evaluate the role of psychological and social variables in women's reactions to genetic testing for ovarian cancer risk with variable education strategies.
3. To consider the effects of variations of genetic education/counseling on genetic knowledge, satisfaction with the decision to undergo testing, and family communication.
4. To examine the cancer screening and prevention behaviors, as well as cascade testing behaviors among patients who tested positive for a pathogenic variant.
5. To determine factors contributing to non-completion of genetic testing in subjects enrolled in a genetic testing trial.
6. To determine the impact of pre- and/or post-test genetic counseling on family communication, genetic testing concerns and screening behaviors.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: