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Completed

NCT Number: NCT05162846

Michigan Genetic Hereditary Testing (MiGHT)

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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Key information

Conditions

Breast Cancer Adnexal Diseases Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders History of Cancer Intestinal Diseases Intestinal Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • 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
  • 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

Exclusion criteria

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

Treatment and study plan

Publicly available genetic testing resources

Other

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

Virtual genetics navigator

Behavioral

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)

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Methods for Increasing Genetic Testing Uptake in Michigan

Acronym: MiGHT

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 17, 2021
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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