Breast Cancer, Colorectal Cancer, Endometrial Cancer, History of Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer
Conditions
Keywords
Genetic testing, Genetic susceptibility to malignant neoplasm
Brief 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. 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.
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.
Interventions
OTHERPublicly available genetic testing resources
Participants may view the publicly available Michigan Department of Health and Human Services (MDHHS) website as they wish.
BEHAVIORALVirtual genetics navigator
A mobile-optimized website/online genetic tool developed by investigators from the University of Michigan's Center for Health Communications Research (CHCR).
BEHAVIORALMotivational interviewing (MI)
At least 2 phone calls delivered by trained genetic health coaches using motivational interviewing and providing genetic testing information.
Sponsors
University of Michigan Rogel Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Complete Clinical Genetic Testing at Six Months After Randomization | 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
| Measure | Time frame | Description |
|---|---|---|
| Motivators of Genetic Testing, for Participants Who Completed Genetic Testing | 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. |
| Barriers to Genetic Testing, for Participants Who Completed Genetic Testing | 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. |
| Barriers to Genetic Testing, for Participants Who Did Not Yet Complete Genetic Testing | 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. |
| Motivators of Genetic Testing, for Participants Who Did Not Yet Complete Genetic Testing | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElena Stoffel, MD, MPH
University of Michigan Rogel Cancer Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 62 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 241 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 71 Participants |
| Race (NIH/OMB) White | 665 Participants |
| Region of Enrollment United States | 793 participants |
| Sex/Gender, Customized Female | 165 Participants |
| Sex/Gender, Customized Male | 98 Participants |
| Sex/Gender, Customized Other | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 267 | 0 / 265 | 0 / 261 |
| other Total, other adverse events | 0 / 267 | 0 / 265 | 0 / 261 |
| serious Total, serious adverse events | 0 / 267 | 0 / 265 | 0 / 261 |
Outcome results
None listed