Methods for Increasing Genetic Testing Uptake in Michigan (MiGHT)

August 17, 2023 updated by: University of Michigan Rogel Cancer Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

759

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Other: Publicly available genetic testing resources
Participants may view the publicly available Michigan Department of Health and Human Services (MDHHS) website as they wish.
Experimental: 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.
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).
Experimental: 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.
Behavioral: Motivational interviewing (MI)
At least 2 phone calls delivered by trained genetic health coaches using motivational interviewing and providing genetic testing information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants who complete clinical genetic testing at six months after randomization
Time Frame: 6 months after enrollment/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
Time Frame: 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.
6 months and 12 months after enrollment/randomization
Barriers to genetic testing, for participants who did not yet complete genetic testing
Time Frame: 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.
6 months and 12 months after enrollment/randomization
Motivators of genetic testing, for participants who completed genetic testing
Time Frame: 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.
6 months and 12 months after enrollment/randomization
Motivators of genetic testing, for participants who did not yet complete genetic testing
Time Frame: 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.
6 months and 12 months after enrollment/randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan Rogel Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Elena Stoffel, MD, MPH, University of Michigan Rogel Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2022

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

December 8, 2021

First Submitted That Met QC Criteria

December 8, 2021

First Posted (Actual)

December 17, 2021

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 17, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCC 2021.076
  • U01CA232827 (U.S. NIH Grant/Contract)
  • HUM00192898 (Other Identifier: University of Michigan)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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