Methods for Increasing Genetic Testing Uptake in Michigan (MiGHT)

University of Michigan Rogel Cancer Center

Status: Completed

Conditions: Endometrial Cancer; Breast Cancer; Ovarian Cancer; Prostate Cancer; History of Cancer; Pancreatic Cancer; Colorectal Cancer

Treatments: Behavioral: Motivational interviewing (MI); Behavioral: Virtual genetics navigator; Other: Publicly available genetic testing resources

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05162846

HUM00192898 (Other Identifier)

U01CA232827 (U.S. NIH Grant/Contract)

UMCC 2021.076

Details and patient eligibility

About

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.

Enrollment: 831 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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831 participants in 3 patient groups

Arm 1 - Usual care (UC)

Active Comparator group

Description:

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.

Treatment:

Other: Publicly available genetic testing resources

Arm 2 - Virtual genetics navigator

Experimental group

Description:

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.

Treatment:

Behavioral: Virtual genetics navigator

Arm 3 - Motivational interviewing (MI)

Experimental group

Description:

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.

Treatment:

Behavioral: Motivational interviewing (MI)