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| ID | Type | Description | Link |
|---|---|---|---|
| R42CA275665 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Wake Forest University Health Sciences | OTHER |
| National Cancer Institute (NCI) | NIH |
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The goal of this clinical trial is to test the feasibility of a web app about colorectal cancer screening in patients with an upcoming primary care appointment. The main questions it aims to answer are:
Participants will receive a text message informing them of the value of colorectal cancer screening, and inviting them to click a hyperlink to learn more. The hyperlink will take participants to the web app. The web app: 1) asks questions and use algorithms to determine if routine colorectal cancer screening is needed, and 2) if screening is indicated, shows a brief educational video about colorectal cancer screening and allows participants to request a screening test via the program.
Researchers will compare four different versions of the text message invitation to see if some messages result in higher program completion rates than others.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Text message 1 | Experimental | Version 1 of the text message invitation to use the cloud-based colorectal cancer screening program |
|
| Text message 2 | Experimental | Version 2 of the text message invitation to use the cloud-based colorectal cancer screening program |
|
| Text message 3 | Experimental | Version 3 of the text message invitation to use the cloud-based colorectal cancer screening program |
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| Text message 4 | Experimental | Version 4 of the text message invitation to use the cloud-based colorectal cancer screening program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mPATH-CRC Web app | Other | Cloud-based web application that informs individuals of colorectal cancer screening and helps them receive screening |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number (and Proportion) of Participants Who Request a Colorectal Cancer (CRC) Screening Test | Number (and proportion) of participants who are confirmed eligible for CRC screening and request a CRC screening test within the mPATH-CRC Web App | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number (and Proportion) of Participants Who Complete the mPATH-CRC Web App | Number (and proportion) of participants who complete the CRC screening eligibility questions within 4 weeks of the initial invitation using the mPATH-CRC Web App | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Miller, MD, MS | Digital Health Navigation Solutions, Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | United States |
The investigators will share the data dictionary and de-identified individual participant data that underlie our published results with researchers who provide a methodologically sound proposal. Use of the data will be limited to achieve the aims in their submitted proposal. To gain access, data requestors will need to sign a data access agreement.
Individual participant data (IPD) and supporting information will be available beginning 6 months and ending 36 months following article publication.
Researchers who provide a methodologically sound proposal will be provided the data dictionary and deidentified participant data that underlie published study results. Use of the data will be limited to achieve the aims in their submitted proposal. To gain access, data requestors will need to sign a data access agreement. Researchers desiring IPD access should email requests to the study PI, Dr. David Miller (dave@mpathhealth.com).
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| ID | Title | Description |
|---|---|---|
| FG000 | Text Message 1 | Version 1 of the text message invitation to use the cloud-based colorectal cancer screening program mPATH-CRC Web app: Cloud-based web application that informs individuals of colorectal cancer screening and helps them receive screening |
| FG001 | Text Message 2 | Version 2 of the text message invitation to use the cloud-based colorectal cancer screening program mPATH-CRC Web app: Cloud-based web application that informs individuals of colorectal cancer screening and helps them receive screening |
| FG002 | Text Message 3 | Version 3 of the text message invitation to use the cloud-based colorectal cancer screening program mPATH-CRC Web app: Cloud-based web application that informs individuals of colorectal cancer screening and helps them receive screening |
| FG003 | Text Message 4 | Version 4 of the text message invitation to use the cloud-based colorectal cancer screening program mPATH-CRC Web app: Cloud-based web application that informs individuals of colorectal cancer screening and helps them receive screening |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Text Message 1 | Version 1 of the text message invitation to use the cloud-based colorectal cancer screening program mPATH-CRC Web app: Cloud-based web application that informs individuals of colorectal cancer screening and helps them receive screening |
| BG001 | Text Message 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number (and Proportion) of Participants Who Request a Colorectal Cancer (CRC) Screening Test | Number (and proportion) of participants who are confirmed eligible for CRC screening and request a CRC screening test within the mPATH-CRC Web App | Patients who used the mPATH-CRC Web App and were confirmed eligible for average-risk colorectal cancer screening | Posted | Count of Participants | Participants | 28 days |
|
No adverse events were collected systematically for this study. The study intervention was a digital health program (a decision aid) for routine colorectal cancer screening as recommended by United States Preventive Services Task Force guidelines. Therefore, no adverse events were expected or collected.
No adverse events were collected systematically for this study. The study intervention was a digital health program (a decision aid) for routine colorectal cancer screening as recommended by United States Preventive Services Task Force guidelines. Therefore, no adverse events were expected or collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Text Message 1 | Version 1 of the text message invitation to use the cloud-based colorectal cancer screening program mPATH-CRC Web app: Cloud-based web application that informs individuals of colorectal cancer screening and helps them receive screening |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anna Snavely | Wake Forest University School of Medicine | 336-716-2011 | asnavely@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 25, 2024 | Jun 1, 2025 | Prot_SAP_000.pdf |
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Version 2 of the text message invitation to use the cloud-based colorectal cancer screening program mPATH-CRC Web app: Cloud-based web application that informs individuals of colorectal cancer screening and helps them receive screening |
| BG002 | Text Message 3 | Version 3 of the text message invitation to use the cloud-based colorectal cancer screening program mPATH-CRC Web app: Cloud-based web application that informs individuals of colorectal cancer screening and helps them receive screening |
| BG003 | Text Message 4 | Version 4 of the text message invitation to use the cloud-based colorectal cancer screening program mPATH-CRC Web app: Cloud-based web application that informs individuals of colorectal cancer screening and helps them receive screening |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Version 2 of the text message invitation to use the cloud-based colorectal cancer screening program mPATH-CRC Web app: Cloud-based web application that informs individuals of colorectal cancer screening and helps them receive screening |
| OG002 | Text Message 3 | Version 3 of the text message invitation to use the cloud-based colorectal cancer screening program mPATH-CRC Web app: Cloud-based web application that informs individuals of colorectal cancer screening and helps them receive screening |
| OG003 | Text Message 4 | Version 4 of the text message invitation to use the cloud-based colorectal cancer screening program mPATH-CRC Web app: Cloud-based web application that informs individuals of colorectal cancer screening and helps them receive screening |
|
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| Secondary | Number (and Proportion) of Participants Who Complete the mPATH-CRC Web App | Number (and proportion) of participants who complete the CRC screening eligibility questions within 4 weeks of the initial invitation using the mPATH-CRC Web App | Posted | Count of Participants | Participants | 28 days |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Text Message 2 | Version 2 of the text message invitation to use the cloud-based colorectal cancer screening program mPATH-CRC Web app: Cloud-based web application that informs individuals of colorectal cancer screening and helps them receive screening | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Text Message 3 | Version 3 of the text message invitation to use the cloud-based colorectal cancer screening program mPATH-CRC Web app: Cloud-based web application that informs individuals of colorectal cancer screening and helps them receive screening | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Text Message 4 | Version 4 of the text message invitation to use the cloud-based colorectal cancer screening program mPATH-CRC Web app: Cloud-based web application that informs individuals of colorectal cancer screening and helps them receive screening | 0 | 0 | 0 | 0 | 0 | 0 |
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