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.
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).
As of April 2023 we were approved by our IRB to expand our inclusion criteria and recruitment cohort. This expansion will enhance our reach to individuals who are not in the acute stages of clinical care as well as individuals who are not in oncology care currently yet still qualify for genetic testing based on their family history of cancer alone or in combination with any personal cancer history. These expansions will also support the unburdening of oncology practices - who continue to face downstream, resource-limiting affects from the COVID-19 pandemic - across the state. The goal and aims of the study remain the same.
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
Personal history of any cancer or no personal history of cancer with either:
i. PREMM score ≥ 2.5%
ii. 1st degree relative with pancreatic, or male breast cancer
iii. 1st or 2nd degree relative with ovarian cancer
iv. 1st degree relative with any of these cancers diagnosed under 50: colon, endometrial, or breast
v. Ashkenazi Jewish ancestry and 1st or 2nd degree relative with breast cancer
Exclusion Criteria:
Prior clinical germline genetic testing for cancer or already have an upcoming appointment scheduled with a genetics provider
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