R01CA248981
Project Grant
Overview
Grant Description
Identifying Multi-Level Barriers and Facilitators to Digital Health Use in Federally Qualified Health Centers - Project Summary/Abstract
Colorectal cancer (CRC) is a leading cause of cancer death in the United States. National guidelines recommend that average risk people receive regular CRC screenings. Community health centers, such as Federally Qualified Health Centers (FQHCs), provide high-quality affordable healthcare to underserved populations across the nation. Among patients treated at FQHCs, only 44% have completed a CRC screening within the recommended timeframe (e.g., one colonoscopy per ten years).
Patient navigation has proven effective for improving CRC screening completion rates and screening quality. The effects of patient navigation are robust across socioeconomic status and racial/ethnic groups. Furthermore, extensive research has proven its efficacy in FQHC settings. Although efficacious, patient navigation requires staffing and economic resources, limiting its ability to be widely disseminated, particularly in low-resourced settings like FQHCs.
The proposed study aims to refine and test a digital health solution, called the eNav Toolkit, designed to improve CRC screening uptake among patients treated at FQHCs. The eNav Toolkit will be a web app that will assist with CRC screening decision making, appointment reminders, preparation instructions/reminders, education, motivational interviewing support, and linkage to follow-up care. In order to maximize reach, the eNav Toolkit will be accessible on any smartphone, tablet, or computer device.
For Aim 1, the eNav Toolkit 1.0 will be field-tested on 10 participants. Participants will be FQHC patients eligible for CRC screening. The field test results will be applied to refine the eNav content and improve the user experience. The second iteration of the intervention, eNav Toolkit 2.0, will then be field-tested on a new set of 10 participants. The results from the second field test will be applied to refine and finalize the eNav Toolkit.
Aim 2 will conduct a multi-site randomized clinical trial to evaluate the efficacy of the eNav Toolkit for improving CRC screening uptake among patients treated at FQHCs. Patients (N=400) will be randomly assigned to one of two conditions: eNav Toolkit group (N=200) or usual care group (N=200). Participants in the eNav Toolkit group will engage with the eNav Toolkit to assist in preparing for and completing the CRC screening. Participants in the usual care group will receive usual care. Primary outcomes (CRC screening completion) and secondary outcomes (CRC screening quality, follow-up adherence) will be evaluated at six months after study enrollment.
Aim 3 will evaluate theoretical mechanisms of change (e.g., perceived benefits, perceived barriers, perceived susceptibility, self-efficacy), guided by the Health Belief Model. If proven efficacious, the eNav Toolkit will be integrated into the electronic health record (EHR) and disseminated across FQHCs nationwide, with the ultimate goal of decreasing the burden of CRC among patients treated at FQHCs.
Colorectal cancer (CRC) is a leading cause of cancer death in the United States. National guidelines recommend that average risk people receive regular CRC screenings. Community health centers, such as Federally Qualified Health Centers (FQHCs), provide high-quality affordable healthcare to underserved populations across the nation. Among patients treated at FQHCs, only 44% have completed a CRC screening within the recommended timeframe (e.g., one colonoscopy per ten years).
Patient navigation has proven effective for improving CRC screening completion rates and screening quality. The effects of patient navigation are robust across socioeconomic status and racial/ethnic groups. Furthermore, extensive research has proven its efficacy in FQHC settings. Although efficacious, patient navigation requires staffing and economic resources, limiting its ability to be widely disseminated, particularly in low-resourced settings like FQHCs.
The proposed study aims to refine and test a digital health solution, called the eNav Toolkit, designed to improve CRC screening uptake among patients treated at FQHCs. The eNav Toolkit will be a web app that will assist with CRC screening decision making, appointment reminders, preparation instructions/reminders, education, motivational interviewing support, and linkage to follow-up care. In order to maximize reach, the eNav Toolkit will be accessible on any smartphone, tablet, or computer device.
For Aim 1, the eNav Toolkit 1.0 will be field-tested on 10 participants. Participants will be FQHC patients eligible for CRC screening. The field test results will be applied to refine the eNav content and improve the user experience. The second iteration of the intervention, eNav Toolkit 2.0, will then be field-tested on a new set of 10 participants. The results from the second field test will be applied to refine and finalize the eNav Toolkit.
Aim 2 will conduct a multi-site randomized clinical trial to evaluate the efficacy of the eNav Toolkit for improving CRC screening uptake among patients treated at FQHCs. Patients (N=400) will be randomly assigned to one of two conditions: eNav Toolkit group (N=200) or usual care group (N=200). Participants in the eNav Toolkit group will engage with the eNav Toolkit to assist in preparing for and completing the CRC screening. Participants in the usual care group will receive usual care. Primary outcomes (CRC screening completion) and secondary outcomes (CRC screening quality, follow-up adherence) will be evaluated at six months after study enrollment.
Aim 3 will evaluate theoretical mechanisms of change (e.g., perceived benefits, perceived barriers, perceived susceptibility, self-efficacy), guided by the Health Belief Model. If proven efficacious, the eNav Toolkit will be integrated into the electronic health record (EHR) and disseminated across FQHCs nationwide, with the ultimate goal of decreasing the burden of CRC among patients treated at FQHCs.
Funding Goals
TO IDENTIFY CANCER RISKS AND RISK REDUCTION STRATEGIES, TO IDENTIFY FACTORS THAT CAUSE CANCER IN HUMANS, AND TO DISCOVER AND DEVELOP MECHANISMS FOR CANCER PREVENTION AND PREVENTIVE INTERVENTIONS IN HUMANS. RESEARCH PROGRAMS INCLUDE: (1) CHEMICAL, PHYSICAL AND MOLECULAR CARCINOGENESIS; (2) SCREENING, EARLY DETECTION AND RISK ASSESSMENT, INCLUDING BIOMARKER DISCOVERY, DEVELOPMENT AND VALIDATION; (3) EPIDEMIOLOGY; (4) NUTRITION AND BIOACTIVE FOOD COMPONENTS; (5) IMMUNOLOGY AND VACCINES; (6) FIELD STUDIES AND STATISTICS; (7) CANCER CHEMOPREVENTION AND INTERCEPTION; (8) PRE-CLINICAL AND CLINICAL AGENT DEVELOPMENT; (9) ORGAN SITE STUDIES AND CLINICAL TRIALS; (10) HEALTH-RELATED QUALITY OF LIFE AND PATIENT-CENTERED OUTCOMES; AND (11) SUPPORTIVE CARE AND MANAGEMENT OF SYMPTOMS AND TOXICITIES. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM; TO STIMULATE TECHNICAL INNOVATION; TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING; TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT; AND TO FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY WOMEN AND SOCIALLY/ECONOMICALLY DISADVANTAGED PERSONS.SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS; TO FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS; TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING, AND FOSTER PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY WOMEN AND SOCIALLY/ECONOMICALLY DISADVANTAGED PERSONS.
Grant Program (CFDA)
Awarding / Funding Agency
Place of Performance
New York,
New York
100296504
United States
Geographic Scope
Single Zip Code
Related Opportunity
Analysis Notes
Amendment Since initial award the End Date has been extended from 03/31/26 to 03/31/27 and the total obligations have increased 383% from $692,818 to $3,348,072.
Icahn School Of Medicine At Mount Sinai was awarded
Digital Health Solution for Improving CRC Screening Uptake in FQHCs
Project Grant R01CA248981
worth $3,348,072
from National Cancer Institute in April 2021 with work to be completed primarily in New York New York United States.
The grant
has a duration of 6 years and
was awarded through assistance program 93.393 Cancer Cause and Prevention Research.
The Project Grant was awarded through grant opportunity Increasing Uptake of Evidence-Based Screening in Diverse Adult Populations (R01 Clinical Trial Optional).
Status
(Ongoing)
Last Modified 4/6/26
Period of Performance
4/1/21
Start Date
3/31/27
End Date
Funding Split
$3.3M
Federal Obligation
$0.0
Non-Federal Obligation
$3.3M
Total Obligated
Activity Timeline
Subgrant Awards
Disclosed subgrants for R01CA248981
Transaction History
Modifications to R01CA248981
Additional Detail
Award ID FAIN
R01CA248981
SAI Number
R01CA248981-2346617395
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Private Institution Of Higher Education
Awarding Office
75NC00 NIH National Cancer Institute
Funding Office
75NC00 NIH National Cancer Institute
Awardee UEI
C8H9CNG1VBD9
Awardee CAGE
1QSQ9
Performance District
NY-13
Senators
Kirsten Gillibrand
Charles Schumer
Charles Schumer
Budget Funding
| Federal Account | Budget Subfunction | Object Class | Total | Percentage |
|---|---|---|---|---|
| National Cancer Institute, National Institutes of Health, Health and Human Services (075-0849) | Health research and training | Grants, subsidies, and contributions (41.0) | $1,333,089 | 100% |
Modified: 4/6/26