Methods for Increasing Genetic Testing Uptake in Michigan

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Methods for Increasing Genetic Testing Uptake in Michigan

Conditions
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Breast Cancer, Colorectal Cancer, Ovarian Cancer, Prostate Cancer, Pancreatic Cancer, Endometrial Cancer, History of Cancer

Intervention / Treatment
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* Other: Publicly available genetic testing resources
* Behavioral: Virtual genetics navigator
* Behavioral: Motivational interviewing (MI)


Participation Criteria
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Eligibility Criteria
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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: Personal history of Breast cancer either: i. Diagnosed under 50 ii. Personal or family history of triple negative breast cancer iii. Ashkenazi Jewish ancestry iv. Male proband v. 1st or 2nd degree relative with ovarian cancer, pancreatic cancer, breast cancer diagnosed under 50, or male breast cancer Personal history of prostate cancer either: i. Diagnosed under 50 ii. Ashkenazi Jewish ancestry iii. 1st or 2nd degree relative with ovarian cancer, pancreatic cancer, breast cancer diagnosed under 50, or male breast cancer Personal history of any cancer or no personal history of cancer with either: i. PREMM risk model score ≥ 2.5% ii. 1st degree relative with pancreatic, or male breast cancer iii. 1st or 2nd degree relative with ovarian cancer iv. 1st or 2nd 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 Personal history of edometrial cancer diagnosed under 50 Personal history of colorectal cancer diagnosed under 50 Personal history of ovarian cancer Personal history of pancreatic cancer Exclusion Criteria: Prior clinical germline genetic testing for cancer or already have an upcoming appointment scheduled with a genetics provider

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1 - Usual care (UC)<br>Participants are provided with a link to the Michigan Department of Health and Human Services (MDHHS) informational website and are instructed to follow up with their oncology provider about genetic testing. | Other: Publicly available genetic testing resources<br>* Participants may view the publicly available Michigan Department of Health and Human Services (MDHHS) website as they wish.<br>|
| Experimental: Arm 2 - Virtual genetics navigator<br>Participants receive access to an online genetics tool, the virtual genetics navigator, to help learn why and how to seek out genetic testing for hereditary cancer syndromes. | Behavioral: Virtual genetics navigator<br>* A mobile-optimized website/online genetic tool developed by investigators from the University of Michigan's Center for Health Communications Research (CHCR).<br>|
| Experimental: Arm 3 - Motivational interviewing (MI)<br>Participants receive up to 2 phone calls from trained genetics health coaches who provide information about genetic testing and use motivational interviewing to encourage participants to seek out clinical genetic testing. | Behavioral: Motivational interviewing (MI)<br>* At least 2 phone calls delivered by trained genetic health coaches using motivational interviewing and providing genetic testing information.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants who complete clinical genetic testing at six months after randomization | The primary outcome is completion of genetic testing (yes/no) at 6 months after randomization by patient self-report. | 6 months after enrollment/randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barriers to genetic testing, for participants who completed genetic testing | Participants who have completed genetic testing (before the 6- or 12-month time point for this survey) will be asked to respond to this 7-item, study-specific survey, developed by the investigators to assess the importance of specific barriers that were identified in a previous, observational study. Each item is scored on a scale from 1-5 (1=not at all; 5=extremely). The mean score for each question, across all participants who completed genetic testing, will be calculated in order to rank the barriers in importance. A higher mean score indicates greater importance of that specific barrier. | 6 months and 12 months after enrollment/randomization | 
| Barriers to genetic testing, for participants who did not yet complete genetic testing | Participants who have not yet completed genetic testing (before the 6- or 12-month time point for this survey) will be asked to respond to this 23-item, study-specific survey, developed by the investigators to assess the importance of specific barriers that were identified in a previous, observational study. Each item is scored on a scale from 1-5 (1=not at all, 5=strongly agree). The mean score for each question, across all participants who have not yet completed genetic testing, will be calculated in order to rank the barriers in importance. A higher mean score indicates greater importance of that specific barrier. | 6 months and 12 months after enrollment/randomization | 
| Motivators of genetic testing, for participants who completed genetic testing | Participants who have completed genetic testing (before the 6- or 12-month time point for this survey) will be asked to respond to this 5-item, study-specific survey, developed by the investigators to assess the importance of specific motivators for future testing. Each item is scored on a scale from 1-5 (1=not at all; 5=extremely). The mean score for each question, across all participants who completed genetic testing, will be calculated in order to rank the motivators in importance. A higher mean score indicates greater importance of that specific motivator. | 6 months and 12 months after enrollment/randomization | 
| Motivators of genetic testing, for participants who did not yet complete genetic testing | Participants who have not yet completed genetic testing (before the 6- or 12-month time point for this survey) will be asked to respond to this 5-item, study-specific survey, developed by the investigators to assess the importance of specific motivators for future testing. Each item is scored on a scale from 1-5 (1=not at all, 5=strongly agree). The mean score for each question, across all participants who have not yet completed genetic testing, will be calculated in order to rank the motivators in importance. A higher mean score indicates greater importance of that specific motivator. | 6 months and 12 months after enrollment/randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Genetic testing, Genetic susceptibility to malignant neoplasm