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

M.D. Anderson Cancer Center

Status

Suspended

Conditions

PMS2 Gene Mutation

RAD51C Gene Mutation

BRIP1 Gene Mutation

PALB2 Gene Mutation

HER2/Neu Negative

RAD51D Gene Mutation

Triple-Negative Breast Carcinoma

MSH6 Gene Mutation

BARD1 Gene Mutation

BRCA1 Gene Mutation

MSH2 Gene Mutation

MLH1 Gene Mutation

Estrogen Receptor Negative

Progesterone Receptor Negative

BRCA2 Gene Mutation

Treatments

Other: Questionnaire Administration

Other: Laboratory Biomarker Analysis

Other: Genetic Counseling

Other: Educational Intervention

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02993068

NCI-2017-01600 (Registry Identifier)

2016-0298 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.
To examine the cancer screening and prevention behaviors, as well as cascade testing behaviors among patients who tested positive for a pathogenic variant.
To determine factors contributing to non-completion of genetic testing in subjects enrolled in a genetic testing trial.
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.

Enrollment

5,200 estimated patients

Sex

Female

Ages

30+ years old

Volunteers

No 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)

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

5,200 participants in 4 patient groups

Arm A (online education)

Experimental group

Description:

Patients watch genetic testing online educational video and receive genetic testing online test results report.

Treatment:

Other: Educational Intervention

Other: Laboratory Biomarker Analysis

Other: Questionnaire Administration

Arm B (online education, post telephone counseling)

Experimental group

Description:

Patients watch genetic testing online educational video, receive genetic testing online test results report, and post-telephone genetic counseling.

Treatment:

Other: Educational Intervention

Other: Genetic Counseling

Other: Laboratory Biomarker Analysis

Other: Questionnaire Administration

Arm C (online education, pre- and post-telephone counselling)

Active Comparator group

Description:

Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, genetic testing online test results report, and post-telephone genetic counseling.

Treatment:

Other: Educational Intervention

Other: Genetic Counseling

Other: Laboratory Biomarker Analysis

Other: Questionnaire Administration

Arm D (online education, pre-telephone counseling)

Experimental group

Description:

Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, and genetic testing online test results report.

Treatment:

Other: Educational Intervention

Other: Genetic Counseling