Methods for Increasing Genetic Testing Uptake in Michigan

Not Applicable

Active, not recruiting

• Conditions: Colorectal Cancer; Pancreatic Cancer; History of Cancer; Ovarian Cancer; Endometrial Cancer; Breast Cancer; Prostate Cancer
• Interventions: Other: Publicly available genetic testing resources; Behavioral: Motivational interviewing (MI); Behavioral: Virtual genetics navigator

• Registration Number: NCT05162846
• Lead Sponsor: University of Michigan Rogel Cancer Center

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2021-12-08
• Study First Posted: 2021-12-17
• Study Start: 2022-04-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-14
• Primary Completion: 2025-07-10
• Study Completion: 2026-01-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 831

Inclusion Criteria

• Able to speak and read English

• Access to the internet

• Completed the Family Health History Tool (FHHT)

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

  1. 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

  2. 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

  3. 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

  4. Personal history of endometrial cancer diagnosed under 50

  5. Personal history of colorectal cancer diagnosed under 50

  6. Personal history of renal cancer diagnosed under 46

  7. Personal history of sarcoma diagnosed under 46 and a 1st or 2nd degree relative with sarcoma, breast cancer, or brain cancer diagnosed under 56

  8. Personal history of brain cancer diagnosed under 46 and a 1st or 2nd degree relative with sarcoma, breast cancer, or brain cancer diagnosed under 56

  9. Personal history of any two of the following cancers with at least one of them diagnosed under 46: breast, sarcoma, or brain

  10. Personal history of ovarian cancer

  11. Personal history of pancreatic cancer

  12. Personal history of adrenal cortical carcinoma

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1 - Usual care (UC)	Publicly available genetic testing resources	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.
Arm 3 - Motivational interviewing (MI)	Motivational interviewing (MI)	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.
Arm 2 - Virtual genetics navigator	Virtual genetics navigator	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Barriers to genetic testing, for participants who completed genetic testing	6 months and 12 months after enrollment/randomization	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.
Motivators of genetic testing, for participants who did not yet complete genetic testing	6 months and 12 months after enrollment/randomization	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.
Barriers to genetic testing, for participants who did not yet complete genetic testing	6 months and 12 months after enrollment/randomization	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.
Motivators of genetic testing, for participants who completed genetic testing	6 months and 12 months after enrollment/randomization	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.

Trial Locations

Locations (1)

University of Michigan Rogel Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States