Breast Cancer Clinical Trial

Methods for Increasing Genetic Testing Uptake in Michigan

Summary

The primary purpose of this study is to compare three interventions, two experimental and one standard of care (usual care), to see if the experimental interventions will increase the likelihood of a participant obtaining guideline-concordant genetic testing. Eligible participants will be randomized (assigned) to one of the following interventions: 1) Virtual genetics navigator, a mobile-optimized website, designed by the investigators, that delivers tailored messages and content; 2) two motivational interviewing (MI) telephone calls delivered by trained genetics health coaches; or 3) usual care.

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Full Description

This trial will be conducted in partnership with the Michigan Department of Health and Human Services (MDHHS) and a network of oncology practices in Michigan, the Michigan Oncology Quality Consortium (MOQC).

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Eligibility Criteria

Inclusion Criteria:

Able to speak and read English
Access to the internet
Completed the Family Health History Tool (FHHT) through the Michigan Oncology Quality Consortium (MOQC).

Meeting clinical criteria for genetic evaluation due to any of the below:

Breast cancer either:

i. Diagnosed under 50
ii. PREMM risk model score ≥ 2.5%
iii. Personal or family history of triple negative breast cancer
iv. Ashkenazi Jewish ancestry
v. Male proband
vi. 1st or 2nd degree relative with ovarian cancer, pancreatic cancer, breast cancer diagnosed under 50, or male breast cancer

Endometrial cancer either:

i. Diagnosed under 50
ii. PREMM risk model score ≥ 2.5%

Prostate cancer either:

i. Diagnosed under 50
ii. PREMM risk model score ≥ 2.5%
iii. Ashkenazi Jewish ancestry
iv. 1st or 2nd degree relative with ovarian cancer, pancreatic cancer, breast cancer diagnosed under 50, or male breast cancer

Colorectal cancer either:

i. Diagnosed under 50
ii. PREMM risk model score ≥ 2.5%
Ovarian cancer
Pancreatic cancer

Exclusion Criteria:

Prior clinical germline genetic testing for cancer or already have an upcoming appointment scheduled with a genetics provider

Study is for people with:

Breast Cancer

Estimated Enrollment:

759

Study ID:

NCT05162846

Recruitment Status:

Recruiting

Sponsor:

University of Michigan Rogel Cancer Center

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There is 1 Location for this study

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University of Michigan Rogel Cancer Center
Ann Arbor Michigan, 48109, United States More Info
Cancer AnswerLine
Contact
800-865-1125
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

759

Study ID:

NCT05162846

Recruitment Status:

Recruiting

Sponsor:


University of Michigan Rogel Cancer Center

How clear is this clinincal trial information?

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