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| ID | Type | Description | Link |
|---|---|---|---|
| U01CA232827 | U.S. NIH Grant/Contract | View source | |
| HUM00192898 | Other Identifier | University of Michigan |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Usual care (UC) | Active Comparator | 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. |
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| Arm 2 - Virtual genetics navigator | Experimental | 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. |
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| Arm 3 - Motivational interviewing (MI) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Publicly available genetic testing resources | Other | Participants may view the publicly available Michigan Department of Health and Human Services (MDHHS) website as they wish. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months after enrollment/randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
Personal history of Breast cancer either:
Personal history of prostate cancer either:
Personal history of any cancer or no personal history of cancer with either:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Elena Stoffel, MD, MPH | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36765432 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 14, 2026 | |
| Reset | Jun 9, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 15, 2024 | Oct 31, 2025 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 14, 2026 | Jun 9, 2026 | |||
| Jun 22, 2026 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| D010051 | Ovarian Neoplasms |
| D011471 | Prostatic Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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| 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). |
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| Motivational interviewing (MI) | Behavioral | At least 2 phone calls delivered by trained genetic health coaches using motivational interviewing and providing genetic testing information. |
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| 6 months and 12 months after enrollment/randomization |
| 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. | 6 months and 12 months after enrollment/randomization |
| 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. | 6 months and 12 months after enrollment/randomization |
| 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. | 6 months and 12 months after enrollment/randomization |
| D017437 |
| Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D010182 | Pancreatic Diseases |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |