Colorectal Cancer
Conditions
Brief summary
The goal of this clinical trial is to test a new smartphone-based program designed to help African American men get screened for colorectal cancer (CRC). The main question it aims to answer is: ° Are African American men who complete the smartphone-based program more likely to get screened for colorectal cancer than men who do not? Participants will: * Complete a baseline survey asking about their colorectal cancer screening history and their thoughts and beliefs about colorectal cancer and the medical system. * Be randomized to receive the new smartphone-based program or to receive text messages containing colorectal cancer education materials designed by the Centers for Disease Control (CDC). The new program sends text messages with information about colorectal cancer. Some of these text messages have links to videos that try to help men overcome anything that may stand in the way of getting screened. * Complete a follow-up survey 6 months after the baseline survey. This survey will ask the same questions as the baseline survey. * A medical records review will be conducted at 6 months to verify whether participants received a colorectal cancer screening test during the study period. Researchers will compare participants who receive the new smartphone-based program to participants who receive the CDC information. The goal is to see whether the smartphone-based program increasing screening more than standard educational materials available on the internet.
Interventions
BEHAVIORALCRC mHealth
Participants receive text messages that contain information about colorectal cancer and screening. Some text messages include links to videos that are intended to reduce barriers to colorectal cancer screening. Other text messages include links to brief web-based assessments. Responses to assessment questions are used to make sure each man receives only the information relevant to his needs. The main educational content is completed in the first 6 weeks. Additional educational and motivation text messages continue for up to 4 more months if a participant reports not having completed colorectal cancer screening.
BEHAVIORALControl
Participants receive text messages that include links to videos and/or brochures developed by the Centers for Disease Control. This information is designed to educate the public about colorectal cancer and motivate screening. Text messages are sent every 2-3 days for 6 weeks.
Sponsors
ISA Associates, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
MALE
Age
45 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* African American/Black * not compliant with current United States Preventive Services Taskforce colorectal cancer screening recommendations * owns a mobile phone capable of text messaging and accessing webpages * able to speak/understand English
Exclusion criteria
* personal history of colorectal cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Received a Colorectal Cancer Screening Test | Month 6 | This measure assesses whether or not a participant received a colorectal cancer screening test since beginning the study. The date and type of screening will be verified via electronic health records. A value of 0 will be recorded if no screening test is found in the electronic health record. A value of 1 will be recorded if a screening test is found in the electronic health record. The percentage of participants with a electronic health record verified screening will be calculated from these values. |
| Percentage of Participants Reporting Yes to Receiving a Colorectal Cancer Screening Test | baseline, 6-months | Participants responded to a multiple-choice item asking whether they had completed a recommended colorectal cancer screening (colonoscopy, FIT, FIT-DNA, virtual colonoscopy, or flexible sigmoidoscopy) in the past 6 months. Response options were Yes/No/I'm not sure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Benefits to Colonoscopy at Month 6 | Month 6 | Measured using Rawl and colleagues' (2001) 5-item perceived benefits to colonoscopy scale. Items are averaged to form a score ranging from 1 to 5 with higher scores indicating higher perceived benefits to colonoscopy. |
| Perceived Severity of Colorectal Cancer at Month 6 | Month 6 | Measured using the 12-item perceived severity subscale of Green and colleagues' (2004) CRC Knowledge, Perceptions, and Screening Survey. Items are averaged to form a score ranging from 1 to 5 with higher scores indicating higher perceived severity. |
| Colorectal Cancer Knowledge at Month 6 | Month 6 | Measured using the 16-item CRC Knowledge test subsection of Green and colleagues' (2004) CRC Knowledge, Perceptions, and Screening Survey. The true/false items are scored 1 (correct) or 0 (incorrect) and summed to form a score ranging from 0 to 16. Higher scores indicate greater colorectal cancer knowledge. |
| Perceived Benefits to Stool Test at Month 6 | Month 6 | Measured using Rawl and colleagues' (2001) 5-item perceived benefits to fecal occult blood test scale. Items are averaged to form a score ranging from 1 to 5 with higher scores indicating higher perceived benefits to stool tests. |
| Perceived Susceptibility to Colorectal Cancer at Month 6 | Month 6 | Measured using the 5-item perceived susceptibility subscale of Green and colleagues' (2004) CRC Knowledge, Perceptions, and Screening Survey. Items are averaged to form a score ranging from 1 to 5 with higher scores indicating higher perceived susceptibility. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CRC mHealth Intervention Experimental group participants will have access to the CRC mHealth intervention. | 63 |
| Control Education Control condition participants will receive information about colorectal cancer and screening developed by the Centers for Disease Control. | 65 |
| Total | 128 |
Baseline characteristics
| Characteristic | Control Education | CRC mHealth Intervention | Total |
|---|---|---|---|
| Age, Continuous | 56.2 years STANDARD_DEVIATION 6.8 | 56.2 years STANDARD_DEVIATION 7.2 | 56.2 years STANDARD_DEVIATION 6.9 |
| Colorectal Cancer Knowledge | 13.37 units on a scale STANDARD_DEVIATION 1.8 | 13.33 units on a scale STANDARD_DEVIATION 1.76 | 13.35 units on a scale STANDARD_DEVIATION 1.77 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 64 Participants | 63 Participants | 127 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Perceived Benefits to Colonoscopy | 4.03 units on a scale STANDARD_DEVIATION 0.54 | 4.08 units on a scale STANDARD_DEVIATION 0.53 | 4.06 units on a scale STANDARD_DEVIATION 0.54 |
| Perceived Benefits to Stool Test | 3.95 units on a scale STANDARD_DEVIATION 0.55 | 3.86 units on a scale STANDARD_DEVIATION 0.51 | 3.91 units on a scale STANDARD_DEVIATION 0.53 |
| Perceived Severity of Colorectal Cancer | 3.03 units on a scale STANDARD_DEVIATION 0.78 | 3.22 units on a scale STANDARD_DEVIATION 0.75 | 3.12 units on a scale STANDARD_DEVIATION 0.77 |
| Perceived Susceptibility to Colorectal Cancer | 2.67 units on a scale STANDARD_DEVIATION 0.83 | 2.77 units on a scale STANDARD_DEVIATION 0.6 | 2.72 units on a scale STANDARD_DEVIATION 0.73 |
| Percentage of Participants Reporting Yes to Receiving a Colorectal Cancer Screening Test | 49.2 percentage of participants screened | 52.4 percentage of participants screened | 50.8 percentage of participants screened |
| 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 | 62 Participants | 61 Participants | 123 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 65 Participants | 63 Participants | 128 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 65 |
| other Total, other adverse events | 0 / 63 | 0 / 65 |
| serious Total, serious adverse events | 0 / 63 | 0 / 65 |
Outcome results
Primary
Percentage of Participants Reporting Yes to Receiving a Colorectal Cancer Screening Test
Participants responded to a multiple-choice item asking whether they had completed a recommended colorectal cancer screening (colonoscopy, FIT, FIT-DNA, virtual colonoscopy, or flexible sigmoidoscopy) in the past 6 months. Response options were Yes/No/I'm not sure.
Time frame: baseline, 6-months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CRC mHealth Intervention | Percentage of Participants Reporting Yes to Receiving a Colorectal Cancer Screening Test | 40.4 Percentage of participants screened |
| Control Education | Percentage of Participants Reporting Yes to Receiving a Colorectal Cancer Screening Test | 17.0 Percentage of participants screened |
Primary
Percentage of Participants Who Received a Colorectal Cancer Screening Test
This measure assesses whether or not a participant received a colorectal cancer screening test since beginning the study. The date and type of screening will be verified via electronic health records. A value of 0 will be recorded if no screening test is found in the electronic health record. A value of 1 will be recorded if a screening test is found in the electronic health record. The percentage of participants with a electronic health record verified screening will be calculated from these values.
Time frame: Month 6
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CRC mHealth Intervention | Percentage of Participants Who Received a Colorectal Cancer Screening Test | 2 Participants |
| Control Education | Percentage of Participants Who Received a Colorectal Cancer Screening Test | 2 Participants |
Secondary
Colorectal Cancer Knowledge at Month 6
Measured using the 16-item CRC Knowledge test subsection of Green and colleagues' (2004) CRC Knowledge, Perceptions, and Screening Survey. The true/false items are scored 1 (correct) or 0 (incorrect) and summed to form a score ranging from 0 to 16. Higher scores indicate greater colorectal cancer knowledge.
Time frame: Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CRC mHealth Intervention | Colorectal Cancer Knowledge at Month 6 | 13.70 score on a scale | Standard Deviation 1.49 |
| Control Education | Colorectal Cancer Knowledge at Month 6 | 13.17 score on a scale | Standard Deviation 1.43 |
Secondary
Perceived Benefits to Colonoscopy at Month 6
Measured using Rawl and colleagues' (2001) 5-item perceived benefits to colonoscopy scale. Items are averaged to form a score ranging from 1 to 5 with higher scores indicating higher perceived benefits to colonoscopy.
Time frame: Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CRC mHealth Intervention | Perceived Benefits to Colonoscopy at Month 6 | 4.23 units on a scale | Standard Deviation 0.51 |
| Control Education | Perceived Benefits to Colonoscopy at Month 6 | 4.11 units on a scale | Standard Deviation 0.54 |
Secondary
Perceived Benefits to Stool Test at Month 6
Measured using Rawl and colleagues' (2001) 5-item perceived benefits to fecal occult blood test scale. Items are averaged to form a score ranging from 1 to 5 with higher scores indicating higher perceived benefits to stool tests.
Time frame: Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CRC mHealth Intervention | Perceived Benefits to Stool Test at Month 6 | 3.91 units on a scale | Standard Deviation 0.52 |
| Control Education | Perceived Benefits to Stool Test at Month 6 | 4.06 units on a scale | Standard Deviation 0.52 |
Secondary
Perceived Severity of Colorectal Cancer at Month 6
Measured using the 12-item perceived severity subscale of Green and colleagues' (2004) CRC Knowledge, Perceptions, and Screening Survey. Items are averaged to form a score ranging from 1 to 5 with higher scores indicating higher perceived severity.
Time frame: Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CRC mHealth Intervention | Perceived Severity of Colorectal Cancer at Month 6 | 2.82 units on a scale | Standard Deviation 0.76 |
| Control Education | Perceived Severity of Colorectal Cancer at Month 6 | 2.59 units on a scale | Standard Deviation 0.61 |
Secondary
Perceived Susceptibility to Colorectal Cancer at Month 6
Measured using the 5-item perceived susceptibility subscale of Green and colleagues' (2004) CRC Knowledge, Perceptions, and Screening Survey. Items are averaged to form a score ranging from 1 to 5 with higher scores indicating higher perceived susceptibility.
Time frame: Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CRC mHealth Intervention | Perceived Susceptibility to Colorectal Cancer at Month 6 | 2.82 units on a scale | Standard Deviation 0.76 |
| Control Education | Perceived Susceptibility to Colorectal Cancer at Month 6 | 2.59 units on a scale | Standard Deviation 0.61 |