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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA248981 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| The Institute for Family Health | OTHER |
| National Cancer Institute (NCI) | NIH |
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The purpose of this research study is to evaluate the efficacy of a digital navigation tool, called the eNav to improve colorectal cancer screening uptake among patients treated at federally qualified health centers (FQHC)s. The digital navigation tool includes a website and text messaging support. The website includes information, motivational support, decisional support and cues to action (e.g., ability to request a CRC screening test). The eNav tool also includes text-messaging based navigation (e.g., reminders, instructions to complete the screening test).
This is a multi-site randomized clinical trial to evaluate the efficacy of the eNav Toolkit. A total of 400 participants will be from four FQHC clinics within the Institute for Family Health FQHC network. Participants will be randomly assigned to one of two groups:
Participants will consent and complete a baseline questionnaire (demographics, medical information) 1-4 weeks before their primary care appointment.
Those in the intervention group will receive a link to the eNav website. The digital navigation tool includes a website and text-messaging support. The website includes information, motivational support, decisional support and cues to action (e.g., ability to request a CRC screening test). The eNav tool also includes text-messaging based navigation (e.g., reminders, instructions to complete the screening test).
The control group will receive standard clinical care.
Then 3-6 weeks after that primary care appointment, the research team will reach out to participants to complete a follow-up questionnaire. The follow up questionnaire will assess constructs guided by the health belief model (e.g., self-efficacy, benefits/barriers for CRC screening).
The impact of the eNav Toolkit on CRC screening completion at 6 months will be evaluated by checking their medical records. If a patient does not have a CRC screening recorded in their medical record, the research team will call the patient to inquire whether they have completed the CRC screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eNav intervention | Experimental | Subjects assigned to this arm will receive a link to the eNav website. |
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| Usual Care Group | Placebo Comparator | Subjects assigned to this arm will not receive the link to the website and will receive standard clinical care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eNav | Other | The eNav toolkit is a digital navigation toolkit that includes a website and text messaging support. The website includes information, motivational support, decisional support and cues to action (e.g., ability to request a CRC screening test). The eNav tool also includes text-messaging based navigation (e.g., reminders, instructions to complete the screening test). |
| Measure | Description | Time Frame |
|---|---|---|
| Colorectal Cancer (CRC) Screening completion | CRC, Yes/No Medical chart review will determine whether the CRC screening was complete. If a patient does not have a CRC screening result recorded in their medical record, the research team will call the patient to inquire whether they have completed the CRC screening. | End of study, at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who complete screening tests with adequate quality | The number of participants who complete the screening test (i.e., colonoscopy, FIT or FIT-DNA) with adequate quality. Test quality will be coded as "inadequate" if the test needs to be repeated or cannot be resulted due to inadequate quality (e.g., poor bowel prep, inadequate stool sample). | End of study, at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Miller, PsyD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 100029 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Immediately following publication. No end date.
Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care | Other | Standard of care procedures for selecting their CRC screening test. |
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| Number of participants who complete the screening test with inadequate preparation | The number of participants who complete the screening test and the preparation is inadequate (e.g., poor bowel prep quality, inadequate stool sample collection). | End of study, at 6 months |
| Adherence to follow up recommendations | Record if the study participant is following the colorectal cancer screening recommendations after the CRC test has been completed. Measured as: Yes = participant completed the recommended follow up No = participant did NOT complete the recommended follow up In process = the recommended follow up does not fall within the 6-month time frame Missing = data not available in the medical chart | End of study, at 6 months |
| The Colorectal Cancer Screening Beliefs Instrument Score | The assessments specifically measure the following Health Belief Model scales:
Higher scores indicate greater benefit/barriers levels of the scale (e.g., higher scores = more barriers, more benefits, higher perceived susceptibility of CRC, higher levels of self-efficacy), there is no summed score. | Approximately 3-4 weeks after primary care appointment |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |