Methods for Increasing Genetic Testing Uptake in Michigan

Breast Cancer Clinical Trial

— MiGHT  

Official title:

Methods for Increasing Genetic Testing Uptake in Michigan

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05162846
• Other study ID #: UMCC 2021.076
• Secondary ID: U01CA232827HUM00
• Status: Recruiting
• Phase: N/A
• Start date: April 21, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2024
• Source: University of Michigan Rogel Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 759
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

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 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

4. Personal history of edometrial cancer diagnosed under 50

5. Personal history of colorectal cancer diagnosed under 50

6. Personal history of ovarian cancer

7. 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

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• History of Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Prostate Cancer

Intervention

Other:
• Publicly available genetic testing resources
Participants may view the publicly available Michigan Department of Health and Human Services (MDHHS) website as they wish.

Behavioral:
• Virtual genetics navigator
A mobile-optimized website/online genetic tool developed by investigators from the University of Michigan's Center for Health Communications Research (CHCR).
• Motivational interviewing (MI)
At least 2 phone calls delivered by trained genetic health coaches using motivational interviewing and providing genetic testing information.

Locations

Country	Name	City	State
United States	University of Michigan Rogel Cancer Center	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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