Colorectal Cancer Screening
Conditions
Keywords
colorectal cancer screening, pragmatic clinical trial, randomized clinical trial, digital health, feasibility study
Brief summary
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: * Among patients who use the web app, what proportion will request a colorectal cancer screening test via the program? * How many patients will respond to a text message intervention to use the web app? 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.
Interventions
OTHERmPATH-CRC Web app
Cloud-based web application that informs individuals of colorectal cancer screening and helps them receive screening
Sponsors
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Digital Health Navigation Solutions, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Have a phone number listed in the electronic health record * Language preference of English in the electronic health record * Have a scheduled primary care appointment within the next 15 days
Exclusion criteria
* Prior diagnosis of colorectal cancer * Prior diagnosis of inflammatory bowel disease * Have a record in the electronic health record of completing a colonoscopy within the last 10 years, a FIT-DNA test within the last 3 years, or a fecal immunochemical test (FIT) within the last 1 year * Have an electronic Charlson Comorbidity Index \> 2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number (and Proportion) of Participants Who Request a Colorectal Cancer (CRC) Screening Test | 28 days | Number (and proportion) of participants who are confirmed eligible for CRC screening and request a CRC screening test within the mPATH-CRC Web App |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number (and Proportion) of Participants Who Complete the mPATH-CRC Web App | 28 days | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 232 |
| 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 | 230 |
| 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 | 229 |
| 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 | 230 |
| Total | 921 |
Baseline characteristics
| Characteristic | Text Message 1 | Text Message 2 | Text Message 3 | Text Message 4 | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 41 Participants | 50 Participants | 52 Participants | 48 Participants | 191 Participants |
| Age, Categorical Between 18 and 65 years | 191 Participants | 180 Participants | 177 Participants | 182 Participants | 730 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 8 Participants | 11 Participants | 10 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 223 Participants | 222 Participants | 218 Participants | 220 Participants | 883 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 3 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 4 Participants | 5 Participants | 4 Participants | 19 Participants |
| Race (NIH/OMB) Black or African American | 100 Participants | 95 Participants | 97 Participants | 96 Participants | 388 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 17 Participants | 12 Participants | 17 Participants | 54 Participants |
| Race (NIH/OMB) White | 117 Participants | 113 Participants | 112 Participants | 113 Participants | 455 Participants |
| Region of Enrollment United States | 232 participants | 230 participants | 229 participants | 230 participants | 921 participants |
| Sex: Female, Male Female | 134 Participants | 142 Participants | 137 Participants | 138 Participants | 551 Participants |
| Sex: Female, Male Male | 98 Participants | 88 Participants | 92 Participants | 92 Participants | 370 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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
Time frame: 28 days
Population: Patients who used the mPATH-CRC Web App and were confirmed eligible for average-risk colorectal cancer screening
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Text Message 1 | Number (and Proportion) of Participants Who Request a Colorectal Cancer (CRC) Screening Test | 16 Participants |
| Text Message 2 | Number (and Proportion) of Participants Who Request a Colorectal Cancer (CRC) Screening Test | 17 Participants |
| Text Message 3 | Number (and Proportion) of Participants Who Request a Colorectal Cancer (CRC) Screening Test | 22 Participants |
| Text Message 4 | Number (and Proportion) of Participants Who Request a Colorectal Cancer (CRC) Screening Test | 19 Participants |
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
Time frame: 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Text Message 1 | Number (and Proportion) of Participants Who Complete the mPATH-CRC Web App | 55 Participants |
| Text Message 2 | Number (and Proportion) of Participants Who Complete the mPATH-CRC Web App | 66 Participants |
| Text Message 3 | Number (and Proportion) of Participants Who Complete the mPATH-CRC Web App | 51 Participants |
| Text Message 4 | Number (and Proportion) of Participants Who Complete the mPATH-CRC Web App | 59 Participants |