Methods for Increasing Genetic Testing Uptake in Michigan

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

831 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-21

Study Completion Date

2025-11-21

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.

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Arm 1 - Usual care (UC)

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.

Group Type ACTIVE_COMPARATOR

Publicly available genetic testing resources

Intervention Type OTHER

Participants may view the publicly available Michigan Department of Health and Human Services (MDHHS) website as they wish.

Arm 2 - 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.

Group Type EXPERIMENTAL

Virtual genetics navigator

Intervention Type BEHAVIORAL

A mobile-optimized website/online genetic tool developed by investigators from the University of Michigan's Center for Health Communications Research (CHCR).

Arm 3 - 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.

Group Type EXPERIMENTAL

Motivational interviewing (MI)

Intervention Type BEHAVIORAL

At least 2 phone calls delivered by trained genetic health coaches using motivational interviewing and providing genetic testing information.

Interventions

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Publicly available genetic testing resources

Participants may view the publicly available Michigan Department of Health and Human Services (MDHHS) website as they wish.

Intervention Type OTHER

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).

Intervention Type BEHAVIORAL

Motivational interviewing (MI)

At least 2 phone calls delivered by trained genetic health coaches using motivational interviewing and providing genetic testing information.

Intervention Type BEHAVIORAL

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)
* 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