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Breast CancerMiGHTNCT05162846

Michigan Genetic Hereditary Testing (MiGHT)

A study testing Publicly available genetic testing resources, Virtual genetics navigator and Motivational interviewing (MI) in people with Breast Cancer and Colorectal Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Breast Cancer, Colorectal Cancer, Ovarian Cancer
What is being tested?
Publicly available genetic testing resources, Virtual genetics navigator and Motivational interviewing (MI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
793 participants
Where
1 siteUnited States
Study dates
21 Apr 2022to 21 Nov 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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:
  • Personal history of Breast cancer either:
  • i. Diagnosed under 50
Show all 29Show fewer
  • 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
  • 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
  • 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
  • Personal history of endometrial cancer diagnosed under 50
  • Personal history of colorectal cancer diagnosed under 50
  • Personal history of renal cancer diagnosed under 46
  • Personal history of sarcoma diagnosed under 46 and a 1st or 2nd degree relative with sarcoma, breast cancer, or brain cancer diagnosed under 56
  • 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
  • Personal history of any two of the following cancers with at least one of them diagnosed under 46: breast, sarcoma, or brain
  • Personal history of ovarian cancer
  • Personal history of pancreatic cancer
  • Personal history of adrenal cortical carcinoma

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: Methods for Increasing Genetic Testing Uptake in Michigan

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.

Read the 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.

Being tested
Publicly available genetic testing resources, Virtual genetics navigator, Motivational interviewing (MI)
Keywords
Genetic testing, Genetic susceptibility to malignant neoplasm
Medical subject headings
Breast Neoplasms, Colorectal Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms, Pancreatic Neoplasms, Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Publicly available genetic testing resourcesOther

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

  • Virtual genetics navigatorBehavioural

    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)Behavioural

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

Study groups in NCT05162846
Study groupRoleWhat they receive
Arm 1 - Usual care (UC)Active comparatorParticipants 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.
Receives: Other: Publicly available genetic testing resources
Arm 2 - Virtual genetics navigatorExperimentalParticipants 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.
Receives: Behavioral: Virtual genetics navigator
Arm 3 - Motivational interviewing (MI)ExperimentalParticipants 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.
Receives: Behavioral: Motivational interviewing (MI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months after enrollment/randomization

Secondary outcomes (4)

  1. 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.

    Measured: 6 months and 12 months after enrollment/randomization

  2. 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.

    Measured: 6 months and 12 months after enrollment/randomization

  3. 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.

    Measured: 6 months and 12 months after enrollment/randomization

  4. 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.

    Measured: 6 months and 12 months after enrollment/randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2021
  2. Study start21 Apr 2022
  3. Primary completion13 Jul 2025
  4. Study completion21 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
793 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05162846
Sponsor's protocol ID
UMCC 2021.076
Other IDs
U01CA232827, HUM00192898
Acronym
MiGHT
Status last verified
Jul 2026
First submitted
8 Dec 2021
Last updated
18 Aug 2026
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Austin S, Delacroix E, Rice JD, Koeppe E, Rizzo E, Hanson EN, Arida-Moody L, Weiner S, Hawley ST, Uhlmann WR, Roberts JS, Pleasant V, Ellis KR, Griggs JJ, Resnicow K, Stoffel EM. Digital and Coaching Interventions for Uptake of Cancer Genetic Testing: The MiGHT Randomized Clinical Trial. JAMA Netw Open. 2026 Oct 1;9(10):e2638274. doi: 10.1001/jamanetworkopen.2026.38274.

    PubMed 42867866

  • Gerido LH, Griggs JJ, Resnicow K, Kidwell KM, Delacroix E, Austin S, Hanson EN, Bacon E, Koeppe E, Goodall S, Demerath M, Rizzo EA, Weiner S, Hawley ST, Uhlmann WR, Roberts JS, Stoffel EM. The Michigan Genetic Hereditary Testing (MiGHT) study's innovative approaches to promote uptake of clinical genetic testing among cancer patients: a study protocol for a 3-arm randomized controlled trial. Trials. 2023 Feb 10;24(1):105. doi: 10.1186/s13063-023-07125-2.

    PubMed 36765432

Questions about this trial

What is this clinical trial studying?

A study testing Publicly available genetic testing resources, Virtual genetics navigator and Motivational interviewing (MI) in people with Breast Cancer and Colorectal Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Complete Clinical Genetic Testing at Six Months After Randomization (time frame: 6 months after enrollment/randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05162846, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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