Colorectal Cancer
Conditions
Brief summary
Colorectal cancer is a common but preventable condition, and increasing colorectal cancer screening is one of the most impactful public health contributions in the field of gastroenterology. Text messaging is a simple, cheap, and rapid method to reach patients that may improve adherence to colonoscopy appointments as well as simplify the process of bowel preparation. The purpose of the study is to evaluate the feasibility of a pilot bidirectional text messaging intervention on attendance for screening/surveillance colonoscopy and bowel preparation quality at an urban VA hospital. The goal is to improve adherence to colonoscopy among patients who are due for a repeat colonoscopy.
Interventions
BEHAVIORALText Message Instructions/Motivation
For instructional messages, earlier messages will remind patients of the colonoscopy appointment and later messages will help patients complete the bowel preparation process in real-time. Motivational messages will be sent along with instructional messages.
Sponsors
National Cancer Institute (NCI)
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
• Has previously undergone a colonoscopy and is currently due for a repeat screening or surveillance colonoscopy at the VA.
Exclusion criteria
* Patients not due for screening or surveillance colonoscopy. This will be based on 2020 guidelines from the U.S. Multi-Society Task Force on Colorectal Cancer. * Patients with personal history of colorectal cancer (CRC)/inflammatory bowel disease/ hereditary colon cancer syndrome or family history of hereditary colon cancer syndrome. These criteria will be determined based on ICD9/10 codes or the medical record.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| National Annie Colonoscopy Survey Score | Day 21 (Up to 7 Days Post-Procedure) | 7-item assessment of participant satisfaction with the Annie text intervention. Items are rated on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree). The total score is the sum of responses and ranges from 7 to 35; higher scores indicate greater satisfaction with the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Attend Scheduled Colonoscopy Appointment | Up to Day 14 | Assessed via patient's electronic health record. |
| Percentage of Participants Who Had Adequate Bowel Preparation at Colonoscopy Appointment | Up to Day 14 | Assessed via patient's electronic health record. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Text Message Intervention Participants in the experimental arm will receive a series of instructional and motivational text messages, which will be sent starting 7-14 days before and until the day of the colonoscopy procedure.
Text Message Instructions/Motivation: For instructional messages, earlier messages will remind patients of the colonoscopy appointment and later messages will help patients complete the bowel preparation process in real-time. Motivational messages will be sent along with instructional messages. | 25 |
| No Intervention Participants will not receive text messages. | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Text Message Intervention | Total | No Intervention |
|---|---|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 7.95 | 63.88 years STANDARD_DEVIATION 7.43 | 62.76 years STANDARD_DEVIATION 6.86 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 11 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 39 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 28 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 11 Participants | 7 Participants |
| Race (NIH/OMB) White | 5 Participants | 11 Participants | 6 Participants |
| Region of Enrollment United States | 25 participants | 50 participants | 25 participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 1 Participants |
| Sex: Female, Male Male | 23 Participants | 47 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
National Annie Colonoscopy Survey Score
7-item assessment of participant satisfaction with the Annie text intervention. Items are rated on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree). The total score is the sum of responses and ranges from 7 to 35; higher scores indicate greater satisfaction with the intervention.
Time frame: Day 21 (Up to 7 Days Post-Procedure)
Population: Control patients were not given text messaging intervention, therefore did not participate in the Annie text message survey. All intervention patients were encouraged to complete the survey, and 16 of 25 did.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Text Message Intervention | National Annie Colonoscopy Survey Score | 29.56 Score on a scale | Standard Deviation 4.16 |
Secondary
Percentage of Participants Who Attend Scheduled Colonoscopy Appointment
Assessed via patient's electronic health record.
Time frame: Up to Day 14
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Text Message Intervention | Percentage of Participants Who Attend Scheduled Colonoscopy Appointment | 96 Percentage of Participants |
| No Intervention | Percentage of Participants Who Attend Scheduled Colonoscopy Appointment | 92 Percentage of Participants |
Secondary
Percentage of Participants Who Had Adequate Bowel Preparation at Colonoscopy Appointment
Assessed via patient's electronic health record.
Time frame: Up to Day 14
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Text Message Intervention | Percentage of Participants Who Had Adequate Bowel Preparation at Colonoscopy Appointment | 79 percentage of participants |
| No Intervention | Percentage of Participants Who Had Adequate Bowel Preparation at Colonoscopy Appointment | 91 percentage of participants |