Trial Outcomes & Findings for Early Detection of GEnetic Risk (EDGE) (NCT NCT04746794)

NCT ID: NCT04746794

Last Updated: 2024-10-09

Results Overview

Fraction of the active clinic patient population that completed screening

Recruitment status

COMPLETED

Study phase

Target enrollment

20184 participants

Primary outcome timeframe

1 year

Results posted on

2024-10-09

Participant Flow

12 primary care clinics (units) were randomized to use one of two engagement strategies. Patients who had an appointment at a clinic randomized to the POC arm were approached using the POC strategy (described below). Patients seen at a DPE clinic were approached using the DPE strategy. Recruitment began in September of 2020 and ended in February of 2023.

As randomization was done by clinic, 115,484 individuals started the study (115,319 patients; 165 primary care providers). The 95,623 patients seen during the 12 month window set by the study protocol serve as the denominator for the main outcomes (proportion of patients who completed the cancer risk assessment screening; proportion of patients who completed genetic testing). 20,184 individuals were officially enrolled through completing surveys or the cancer risk assessment screening.

Unit of analysis: Clinics

Participant milestones

Participant milestones
Measure	Point of Care Clinics in the point of care (POC) arm approached patients at the time they came in to the clinic for a routine visit with their primary care provider. The familial cancer risk screening was completed using electronic tablets in the waiting room or, in the case of a telehealth visit, through telephone contact before the visit. Patients identified as likely to benefit based on their risk profile, were offered genetic testing for a panel of hereditary cancers.	Direct Patient Engagement Clinics in the direct patient engagement (DPE) arm contacted patients by postal mail and email to provide a link to the online familial cancer risk screening tool. This occurred one to three months after the patient had a routine visit with their primary care provider. Patients identified as likely to benefit based on their risk profile, were offered genetic testing for a panel of hereditary cancers.
Overall Study STARTED	63820 6	51664 6
Overall Study Patients With a Primary Care Visit	63750 6	51664 6
Overall Study Clinic Primary Care Providers and Clinic Leaders	70 6	95 6
Overall Study Completed Surveys Only (Providers and Clinic Leaders)	46 6	37 6
Overall Study Completed Surveys Only (Patients)	2323 6	2272 6
Overall Study Completed Cancer Risk Screening (Patients)	11148 6	4358 6
Overall Study TOTAL ENROLLED	13517 6	6667 6
Overall Study Patients With a Primary Care Visit During 12m Study Window	51693 6	43930 6
Overall Study Health System A - Patients in 12m Study Window	29862 3	21457 3
Overall Study Completed Cancer Risk Screening During 12m Study Window	9892 6	3813 6
Overall Study Eligible for Genetic Testing	3070 6	1603 6
Overall Study Completed Genetic Testing	757 6	717 6
Overall Study COMPLETED	13517 6	6667 6
Overall Study NOT COMPLETED	50303 0	44997 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Point of Care Clinics in the point of care (POC) arm approached patients at the time they came in to the clinic for a routine visit with their primary care provider. The familial cancer risk screening was completed using electronic tablets in the waiting room or, in the case of a telehealth visit, through telephone contact before the visit. Patients identified as likely to benefit based on their risk profile, were offered genetic testing for a panel of hereditary cancers.	Direct Patient Engagement Clinics in the direct patient engagement (DPE) arm contacted patients by postal mail and email to provide a link to the online familial cancer risk screening tool. This occurred one to three months after the patient had a routine visit with their primary care provider. Patients identified as likely to benefit based on their risk profile, were offered genetic testing for a panel of hereditary cancers.
Overall Study Did not complete any study assessment	50303	44997

Baseline Characteristics

Primary Care Providers and Clinic Leaders were not asked for their age.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 1 year

Population: Patients 25 years of age or older, comfortable speaking English, who had an appointment at one of the participating clinics during the 12 month recruitment window.

Fraction of the active clinic patient population that completed screening

Outcome measures

Outcome measures
Measure	Point of Care n=51693 Participants Clinics in the point of care (POC) arm approached patients at the time they came in to the clinic for a routine visit with their primary care provider. The familial cancer risk screening was completed using electronic tablets in the waiting room or, in the case of a telehealth visit, through telephone contact before the visit. Patients identified as likely to benefit based on their risk profile, were offered genetic testing for a panel of hereditary cancers.	Direct Patient Engagement n=43930 Participants Clinics in the direct patient engagement (DPE) arm contacted patients by postal mail and email to provide a link to the online familial cancer risk screening tool. This occurred one to three months after the patient had a routine visit with their primary care provider. Patients identified as likely to benefit based on their risk profile, were offered genetic testing for a panel of hereditary cancers.
Rates of Screening	9892 Participants	3813 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Patients 25 years of age or older, comfortable speaking English, who had an appointment at one of the participating clinics during the 12 month recruitment window.

Fraction of the active clinic patient population that completed genetic testing.

Outcome measures

Outcome measures
Measure	Point of Care n=51693 Participants Clinics in the point of care (POC) arm approached patients at the time they came in to the clinic for a routine visit with their primary care provider. The familial cancer risk screening was completed using electronic tablets in the waiting room or, in the case of a telehealth visit, through telephone contact before the visit. Patients identified as likely to benefit based on their risk profile, were offered genetic testing for a panel of hereditary cancers.	Direct Patient Engagement n=43930 Participants Clinics in the direct patient engagement (DPE) arm contacted patients by postal mail and email to provide a link to the online familial cancer risk screening tool. This occurred one to three months after the patient had a routine visit with their primary care provider. Patients identified as likely to benefit based on their risk profile, were offered genetic testing for a panel of hereditary cancers.
Rates of Testing	757 Participants	717 Participants

SECONDARY outcome

Timeframe: 2 years

Population: Data from only one of the participating healthcare systems were used. There were 3 clinics in the POC arm and 3 clinics in the DPE arm. Costs were calculated at the per-patient level and scaled to apply to a theoretical healthcare system with 100,000 patients.

This outcome is the total costs for each engagement strategy, scaled to a healthcare system of 100,000 patients. The total costs from the health-system perspective is the sum of program costs and staff costs over 2 years, in U.S. dollars. The cost from the limited societal perspective includes patient costs in addition to health-system costs. The total costs will be used in the incremental cost calculation below.

Outcome measures

Outcome measures
Measure	Point of Care n=29 Participants Clinics in the point of care (POC) arm approached patients at the time they came in to the clinic for a routine visit with their primary care provider. The familial cancer risk screening was completed using electronic tablets in the waiting room or, in the case of a telehealth visit, through telephone contact before the visit. Patients identified as likely to benefit based on their risk profile, were offered genetic testing for a panel of hereditary cancers.	Direct Patient Engagement n=21 Participants Clinics in the direct patient engagement (DPE) arm contacted patients by postal mail and email to provide a link to the online familial cancer risk screening tool. This occurred one to three months after the patient had a routine visit with their primary care provider. Patients identified as likely to benefit based on their risk profile, were offered genetic testing for a panel of hereditary cancers.
Total Cost of Each Engagement Strategy Cost from health-system perspective	640,776 cost in $	697,116 cost in $
Total Cost of Each Engagement Strategy Cost from limited societal perspective (includes patient costs)	648,395 cost in $	698,350 cost in $

SECONDARY outcome

Timeframe: 2 years

Population: Costs and outcomes were compared between the two arms, with POC as the comparator (standard); that is DPE minus POC. Costs were calculated at the per-patient level and scaled to apply to a theoretical healthcare system with 100,000 patients. As this outcome is the difference between the two strategies, only one value is calculated using the data from the two arms combined. The total costs per arm used for this calculation are shown in outcome 3 above.

This outcome is the comparative (incremental) cost of two different engagement strategies for population-based risk assessment for hereditary cancer genetic screening and testing in primary care. The total costs for each arm are presented in outcome 3 above. The incremental cost is the difference in total costs when comparing the DPE arm to the POC arm (DPE minus POC).

Outcome measures

Outcome measures
Measure	Point of Care n=51 Participants Clinics in the point of care (POC) arm approached patients at the time they came in to the clinic for a routine visit with their primary care provider. The familial cancer risk screening was completed using electronic tablets in the waiting room or, in the case of a telehealth visit, through telephone contact before the visit. Patients identified as likely to benefit based on their risk profile, were offered genetic testing for a panel of hereditary cancers.	Direct Patient Engagement Clinics in the direct patient engagement (DPE) arm contacted patients by postal mail and email to provide a link to the online familial cancer risk screening tool. This occurred one to three months after the patient had a routine visit with their primary care provider. Patients identified as likely to benefit based on their risk profile, were offered genetic testing for a panel of hereditary cancers.
Incremental Cost When Comparing Two Engagement Strategies Incremental cost from limited societal perspective (includes patient costs)	49,955 cost in $	—
Incremental Cost When Comparing Two Engagement Strategies Incremental cost from health-system perspective	56,340 cost in $	—

SECONDARY outcome

Timeframe: 2 years

Population: Data from only one of the participating healthcare systems were used. There were 3 clinics in the POC arm and 3 clinics in the DPE arm. The percentages (i.e. proportions) in the table are based on study participant counts. These proportions will be scaled to a healthcare system of 100,000 patients when calculating the incremental differences for Outcome 6.

The table displays the percentages (i.e., proportions) of screening and testing that occurred in the study. The number of patients screened and the number tested are listed as well, but as the denominators differ, the results for Outcome 6 will be based on scaling the proportions to a theoretical healthcare system with 100,000 patients. This information will then be used along with the incremental costs for a healthcare system with 100,000 patients (Outcome 4) to determine the incremental cost-effectiveness ratios (ICERs) presented in Outcome 7.

Outcome measures

Outcome measures
Measure	Point of Care n=29 Participants Clinics in the point of care (POC) arm approached patients at the time they came in to the clinic for a routine visit with their primary care provider. The familial cancer risk screening was completed using electronic tablets in the waiting room or, in the case of a telehealth visit, through telephone contact before the visit. Patients identified as likely to benefit based on their risk profile, were offered genetic testing for a panel of hereditary cancers.	Direct Patient Engagement n=21 Participants Clinics in the direct patient engagement (DPE) arm contacted patients by postal mail and email to provide a link to the online familial cancer risk screening tool. This occurred one to three months after the patient had a routine visit with their primary care provider. Patients identified as likely to benefit based on their risk profile, were offered genetic testing for a panel of hereditary cancers.
Rates of Screening and Testing at Healthcare System A Patients screened	4,327 Participants	1,370 Participants
Rates of Screening and Testing at Healthcare System A Patients tested	233 Participants	254 Participants

SECONDARY outcome

Timeframe: 2 years

Population: NOTE: percentages (i.e., proportions) shown in Outcome 5 were scaled to a healthcare system of 100,000 patients before calculating these incremental differences. Outcomes were then compared between the two arms (DPE minus POC). As this outcome is the difference between the two strategies, only one value is calculated using the data from the two arms combined. Again, differences were calculated after scaling the proportions, rather than simply using the participant counts from Outcome 5.

This outcome is the comparative (incremental) difference between the two different engagement strategies in screening and testing outcomes. The total patients screened and tested for each arm are presented in outcome 5 above. The proportions for these outcomes were then scaled to a healthcare system of 100,000 patients and the incremental difference was calculated by comparing the DPE arm to the POC arm (DPE minus POC). Scaling the numbers to a healthcare system of 100,000 patients is necessary for this component to be compatible with the costs for a healthcare system of 100,000 patients given in Outcome 4, in order to calculate the ICERs (Outcome 7).

Outcome measures

Outcome measures
Measure	Point of Care n=51 Participants Clinics in the point of care (POC) arm approached patients at the time they came in to the clinic for a routine visit with their primary care provider. The familial cancer risk screening was completed using electronic tablets in the waiting room or, in the case of a telehealth visit, through telephone contact before the visit. Patients identified as likely to benefit based on their risk profile, were offered genetic testing for a panel of hereditary cancers.	Direct Patient Engagement Clinics in the direct patient engagement (DPE) arm contacted patients by postal mail and email to provide a link to the online familial cancer risk screening tool. This occurred one to three months after the patient had a routine visit with their primary care provider. Patients identified as likely to benefit based on their risk profile, were offered genetic testing for a panel of hereditary cancers.
Incremental Patients Screened; Incremental Patients Tested Incremental patients screened	-8,105 participants	—
Incremental Patients Screened; Incremental Patients Tested Incremental patients tested	404 participants	—

SECONDARY outcome

Timeframe: 2 years

Population: Costs and outcomes were compared between the two arms, with POC as the comparator (standard); in other words DPE minus POC. This combination of the two arms was the prespecified analysis. Cost effectiveness was calculated at the per-patient level, then scaled to apply to a theoretical healthcare system with 100,000 patients.

This outcome is the Incremental Cost-effectiveness Ratio (ICER). The ICER estimates how much the DPE strategy costs, relative to the POC strategy (DPE minus POC), to improve the outcome measure by 1 unit (in this case one additional patient screened or one additional patient tested). The ICER is calculated by using the difference in costs (outcome 4) divided by the difference in outcome (outcome 6). When the numerator is positive and the denominator is negative (as it is for screening), general practice is to state the second strategy (DPE in this case) was "dominated" by the first strategy (the standard, which is POC in this case). A negative ICER can be misinterpreted, making this clarification necessary.

Outcome measures

Outcome measures
Measure	Point of Care n=51 Participants Clinics in the point of care (POC) arm approached patients at the time they came in to the clinic for a routine visit with their primary care provider. The familial cancer risk screening was completed using electronic tablets in the waiting room or, in the case of a telehealth visit, through telephone contact before the visit. Patients identified as likely to benefit based on their risk profile, were offered genetic testing for a panel of hereditary cancers.	Direct Patient Engagement Clinics in the direct patient engagement (DPE) arm contacted patients by postal mail and email to provide a link to the online familial cancer risk screening tool. This occurred one to three months after the patient had a routine visit with their primary care provider. Patients identified as likely to benefit based on their risk profile, were offered genetic testing for a panel of hereditary cancers.
Incremental Cost-effectiveness Ratio (ICER) Per Patient Screened; Incremental Cost-effectiveness Ratio Per Patient Tested ICER per additional patient screened from limited societal perspective	-6 $ per additional patient	—
Incremental Cost-effectiveness Ratio (ICER) Per Patient Screened; Incremental Cost-effectiveness Ratio Per Patient Tested ICER per additional patient tested from health-system perspective	140 $ per additional patient	—
Incremental Cost-effectiveness Ratio (ICER) Per Patient Screened; Incremental Cost-effectiveness Ratio Per Patient Tested ICER per additional patient screened from health-system perspective	-7 $ per additional patient	—
Incremental Cost-effectiveness Ratio (ICER) Per Patient Screened; Incremental Cost-effectiveness Ratio Per Patient Tested ICER per additional patient tested from limited societal perspective	124 $ per additional patient	—

Adverse Events

Point of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Direct Patient Engagement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Faith Beers

University of Washington

Phone: 206-543-1733

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Point of Care n=6 Clinics Clinics in the point of care (POC) arm approached patients at the time they came in to the clinic for a routine visit with their primary care provider. The familial cancer risk screening was completed using electronic tablets in the waiting room or, in the case of a telehealth visit, through telephone contact before the visit. Patients identified as likely to benefit based on their risk profile, were offered genetic testing for a panel of hereditary cancers.	Direct Patient Engagement n=6 Clinics Clinics in the direct patient engagement (DPE) arm contacted patients by postal mail and email to provide a link to the online familial cancer risk screening tool. This occurred one to three months after the patient had a routine visit with their primary care provider. Patients identified as likely to benefit based on their risk profile, were offered genetic testing for a panel of hereditary cancers.	Total n=12 Clinics Total of all reporting groups
Age, Continuous Patients who completed cancer risk assessment screening	59.0 years STANDARD_DEVIATION 16.2 • n=11148 Participants • Primary Care Providers and Clinic Leaders were not asked for their age.	58.0 years STANDARD_DEVIATION 14.9 • n=4358 Participants • Primary Care Providers and Clinic Leaders were not asked for their age.	58.9 years STANDARD_DEVIATION 15.1 • n=15506 Participants • Primary Care Providers and Clinic Leaders were not asked for their age.
Age, Continuous Patients who completed a baseline survey	61.7 years STANDARD_DEVIATION 15.2 • n=1128 Participants • Primary Care Providers and Clinic Leaders were not asked for their age.	61.0 years STANDARD_DEVIATION 15.3 • n=1191 Participants • Primary Care Providers and Clinic Leaders were not asked for their age.	61.3 years STANDARD_DEVIATION 15.3 • n=2319 Participants • Primary Care Providers and Clinic Leaders were not asked for their age.
Sex/Gender, Customized Female (Patients)	7359 Participants n=12276 Participants • Analysis for Patients is listed separately from Providers and Clinic Leaders.	3834 Participants n=5549 Participants • Analysis for Patients is listed separately from Providers and Clinic Leaders.	11193 Participants n=17825 Participants • Analysis for Patients is listed separately from Providers and Clinic Leaders.
Sex/Gender, Customized Male (Patients)	4481 Participants n=12276 Participants • Analysis for Patients is listed separately from Providers and Clinic Leaders.	1693 Participants n=5549 Participants • Analysis for Patients is listed separately from Providers and Clinic Leaders.	6174 Participants n=17825 Participants • Analysis for Patients is listed separately from Providers and Clinic Leaders.
Sex/Gender, Customized Unknown (Patients)	436 Participants n=12276 Participants • Analysis for Patients is listed separately from Providers and Clinic Leaders.	22 Participants n=5549 Participants • Analysis for Patients is listed separately from Providers and Clinic Leaders.	458 Participants n=17825 Participants • Analysis for Patients is listed separately from Providers and Clinic Leaders.
Sex/Gender, Customized Female (Providers and Clinic Leaders)	21 Participants n=40 Participants • Analysis for Patients is listed separately from Providers and Clinic Leaders.	16 Participants n=33 Participants • Analysis for Patients is listed separately from Providers and Clinic Leaders.	37 Participants n=73 Participants • Analysis for Patients is listed separately from Providers and Clinic Leaders.
Sex/Gender, Customized Male (Providers and Clinic Leaders)	12 Participants n=40 Participants • Analysis for Patients is listed separately from Providers and Clinic Leaders.	10 Participants n=33 Participants • Analysis for Patients is listed separately from Providers and Clinic Leaders.	22 Participants n=73 Participants • Analysis for Patients is listed separately from Providers and Clinic Leaders.
Sex/Gender, Customized Unknown (Providers and Clinic Leaders)	7 Participants n=40 Participants • Analysis for Patients is listed separately from Providers and Clinic Leaders.	7 Participants n=33 Participants • Analysis for Patients is listed separately from Providers and Clinic Leaders.	14 Participants n=73 Participants • Analysis for Patients is listed separately from Providers and Clinic Leaders.
Ethnicity (NIH/OMB) Patients · Hispanic or Latino	21 Participants n=1128 Participants • Ethnicity was NOT asked of patients who completed the cancer risk assessment screening.	37 Participants n=1191 Participants • Ethnicity was NOT asked of patients who completed the cancer risk assessment screening.	58 Participants n=2319 Participants • Ethnicity was NOT asked of patients who completed the cancer risk assessment screening.
Ethnicity (NIH/OMB) Patients · Not Hispanic or Latino	997 Participants n=1128 Participants • Ethnicity was NOT asked of patients who completed the cancer risk assessment screening.	1046 Participants n=1191 Participants • Ethnicity was NOT asked of patients who completed the cancer risk assessment screening.	2043 Participants n=2319 Participants • Ethnicity was NOT asked of patients who completed the cancer risk assessment screening.
Ethnicity (NIH/OMB) Patients · Unknown or Not Reported	110 Participants n=1128 Participants • Ethnicity was NOT asked of patients who completed the cancer risk assessment screening.	108 Participants n=1191 Participants • Ethnicity was NOT asked of patients who completed the cancer risk assessment screening.	218 Participants n=2319 Participants • Ethnicity was NOT asked of patients who completed the cancer risk assessment screening.
Ethnicity (NIH/OMB) Providers and Clinic Leaders · Hispanic or Latino	1 Participants n=40 Participants • Ethnicity was NOT asked of patients who completed the cancer risk assessment screening.	2 Participants n=33 Participants • Ethnicity was NOT asked of patients who completed the cancer risk assessment screening.	3 Participants n=73 Participants • Ethnicity was NOT asked of patients who completed the cancer risk assessment screening.
Ethnicity (NIH/OMB) Providers and Clinic Leaders · Not Hispanic or Latino	30 Participants n=40 Participants • Ethnicity was NOT asked of patients who completed the cancer risk assessment screening.	23 Participants n=33 Participants • Ethnicity was NOT asked of patients who completed the cancer risk assessment screening.	53 Participants n=73 Participants • Ethnicity was NOT asked of patients who completed the cancer risk assessment screening.
Ethnicity (NIH/OMB) Providers and Clinic Leaders · Unknown or Not Reported	9 Participants n=40 Participants • Ethnicity was NOT asked of patients who completed the cancer risk assessment screening.	8 Participants n=33 Participants • Ethnicity was NOT asked of patients who completed the cancer risk assessment screening.	17 Participants n=73 Participants • Ethnicity was NOT asked of patients who completed the cancer risk assessment screening.
Race (NIH/OMB) Patients · American Indian or Alaska Native	7 Participants n=1128 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.	11 Participants n=1191 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.	18 Participants n=2319 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.
Race (NIH/OMB) Patients · Asian	21 Participants n=1128 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.	31 Participants n=1191 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.	52 Participants n=2319 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.
Race (NIH/OMB) Patients · Native Hawaiian or Other Pacific Islander	4 Participants n=1128 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.	2 Participants n=1191 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.	6 Participants n=2319 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.
Race (NIH/OMB) Patients · Black or African American	14 Participants n=1128 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.	17 Participants n=1191 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.	31 Participants n=2319 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.
Race (NIH/OMB) Patients · White	1000 Participants n=1128 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.	1037 Participants n=1191 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.	2037 Participants n=2319 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.
Race (NIH/OMB) Patients · More than one race	33 Participants n=1128 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.	38 Participants n=1191 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.	71 Participants n=2319 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.
Race (NIH/OMB) Patients · Unknown or Not Reported	49 Participants n=1128 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.	55 Participants n=1191 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.	104 Participants n=2319 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.
Race (NIH/OMB) Providers and Clinic Leaders · American Indian or Alaska Native	0 Participants n=40 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.	0 Participants n=33 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.	0 Participants n=73 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.
Race (NIH/OMB) Providers and Clinic Leaders · Asian	2 Participants n=40 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.	4 Participants n=33 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.	6 Participants n=73 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.
Race (NIH/OMB) Providers and Clinic Leaders · Native Hawaiian or Other Pacific Islander	0 Participants n=40 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.	0 Participants n=33 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.	0 Participants n=73 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.
Race (NIH/OMB) Providers and Clinic Leaders · Black or African American	0 Participants n=40 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.	0 Participants n=33 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.	0 Participants n=73 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.
Race (NIH/OMB) Providers and Clinic Leaders · White	31 Participants n=40 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.	20 Participants n=33 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.	51 Participants n=73 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.
Race (NIH/OMB) Providers and Clinic Leaders · More than one race	0 Participants n=40 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.	3 Participants n=33 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.	3 Participants n=73 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.
Race (NIH/OMB) Providers and Clinic Leaders · Unknown or Not Reported	7 Participants n=40 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.	6 Participants n=33 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.	13 Participants n=73 Participants • Race was NOT asked of patients who completed the cancer risk assessment screening.
Region of Enrollment United States	12316 Participants n=12316 Participants	5582 Participants n=5582 Participants	17898 Participants n=17898 Participants