Clinical trial NCT02993068: Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible)
Official title: Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: 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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-12-14
Enrollment: 5200
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Mean cancer stress scores
timeFrame: Up to 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Karen H Lu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coffin T, Bowen D, Lu K, Swisher EM, Rayes N, Norquist B, Blank SV, Levine DA, Bakkum-Gamez JN, Fleming GF, I Olopade O, Romero I, D'Andrea A, Nebgen DR, Peterson C, Munsell MF, Gavin K, Crase J, Polinsky D, Lechner R. Using Social Media to Facilitate Communication About Women's Testing: Tool Validation Study. JMIR Form Res. 2022 Sep 26;6(9):e35035. doi: 10.2196/35035.
citation: Rayes N, Bowen DJ, Coffin T, Nebgen D, Peterson C, Munsell MF, Gavin K, Lechner R, Crase J, Polinsky D, Romero I, Blank SV, Levine DA, Norquist BM, Swisher EM, Lu KH. MAGENTA (Making Genetic testing accessible): a prospective randomized controlled trial comparing online genetic education and telephone genetic counseling for hereditary cancer genetic testing. BMC Cancer. 2019 Jul 2;19(1):648. doi: 10.1186/s12885-019-5868-x.