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

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT02993068

Collaborator

National Cancer Institute (NCI) (NIH)

4,000

Enrollment

Locations

Arms

Anticipated Duration (Months)

2000

Patients Per Site

27.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
BARD1 Gene Mutation BRCA1 Gene Mutation BRCA2 Gene Mutation BRIP1 Gene Mutation Estrogen Receptor Negative HER2/Neu Negative MLH1 Gene Mutation MSH2 Gene Mutation MSH6 Gene Mutation PALB2 Gene Mutation PMS2 Gene Mutation Progesterone Receptor Negative RAD51C Gene Mutation RAD51D Gene Mutation Triple-Negative Breast Carcinoma	Other: Educational Intervention Other: Genetic Counseling Other: Genetic Counseling Other: Laboratory Biomarker Analysis Other: Questionnaire Administration	Early Phase 1

Detailed Description

PRIMARY OBJECTIVES:

To test the effects of online genetic education versus telephone genetic counseling on cancer-risk distress.

SECONDARY OBJECTIVES:

To test the effects of online genetic education versus telephone genetic counseling on testing completion rates.
To evaluate the role of psychological and social variables in women's reactions to genetic testing for ovarian cancer risk with variable education strategies.
To consider the effects of variations of genetic education/counseling on genetic knowledge, satisfaction with the decision to undergo testing, and family communication.

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 Design

Study Type:

Interventional

Anticipated Enrollment :

4000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Apr 18, 2017

Anticipated Primary Completion Date :

Apr 18, 2023

Anticipated Study Completion Date :

Apr 18, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A (online education) Patients watch genetic testing online educational video and receive genetic testing online test results report.	Other: Educational Intervention Watch genetic testing online educational video Other Names: Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Other: Laboratory Biomarker Analysis Correlative studies Other: Questionnaire Administration Ancillary studies
Experimental: Arm B (online education, post telephone counseling) Patients watch genetic testing online educational video, receive genetic testing online test results report, and post-telephone genetic counseling.	Other: Educational Intervention Watch genetic testing online educational video Other Names: Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Other: Genetic Counseling Receive post-telephone genetic counseling Other: Laboratory Biomarker Analysis Correlative studies Other: Questionnaire Administration Ancillary studies
Active Comparator: Arm C (online education, pre- and post-telephone counselling) Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, genetic testing online test results report, and post-telephone genetic counseling.	Other: Educational Intervention Watch genetic testing online educational video Other Names: Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Other: Genetic Counseling Receive post-telephone genetic counseling Other: Genetic Counseling Receive pre-telephone genetic counseling Other: Laboratory Biomarker Analysis Correlative studies Other: Questionnaire Administration Ancillary studies
Experimental: Arm D (online education, pre-telephone counseling) Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, and genetic testing online test results report.	Other: Educational Intervention Watch genetic testing online educational video Other Names: Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Other: Genetic Counseling Receive pre-telephone genetic counseling Other: Laboratory Biomarker Analysis Correlative studies Other: Questionnaire Administration Ancillary studies

Outcome Measures

Primary Outcome Measures

Mean cancer stress scores [Up to 4 years]
Mean cancer stress scores are measured on the Impact of Events Scale (IES), a 15-item self-report measure that assesses subjective distress caused by traumatic events, which may include a positive genetic test result.There are two subscales, Intrusion and Avoidance, used to calculate a total. The range for Intrusion is 0-35 and the range for Avoidance is 0-40. The range of the total score is 0-75. Higher scores reflect more stressful impact, and therefore, a worse outcome. Subscales are summed to compute the total score.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Personal history of ovarian cancer
Unable to read, speak, and understand English
Unable to provide informed consent
Unwilling to complete baseline and follow-up questionnaires
Unable to access the internet
Previous genetic testing or counseling regarding cancer risk
Previous bone marrow transplant
Previous blood transfusion (7 days prior to genetic testing)
Active hematologic malignancy (cancer that begins in blood-forming tissue, such as leukemia or lymphoma)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030
2	University of Washington Medical Center	Seattle	Washington	United States	98195

Sponsors and Collaborators

M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Investigators

Principal Investigator: Karen H Lu, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

University of Texas MD Anderson Cancer Center MAGENTA Study Website

Publications

None provided.

Responsible Party:

M.D. Anderson Cancer Center

ClinicalTrials.gov Identifier:

NCT02993068

Other Study ID Numbers:

2016-0298
NCI-2017-01600
2016-0298
P30CA016672

First Posted:

Dec 14, 2016

Last Update Posted:

Jun 15, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Jun 15, 2022