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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRC mHealth intervention | Experimental | Experimental group participants will have access to the CRC mHealth intervention. |
|
| Control Education | Active Comparator | Control condition participants will receive information about colorectal cancer and screening developed by the Centers for Disease Control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRC mHealth | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 6 |
| 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. | baseline, 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samantha L Leaf, Ph.D. | ISA Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ISA Associates, Inc. | Alexandria | Virginia | 22314 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | CRC mHealth Intervention | Experimental group participants will have access to the CRC mHealth intervention. |
| FG001 | Control Education | Control condition participants will receive information about colorectal cancer and screening developed by the Centers for Disease Control. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CRC mHealth Intervention | Experimental group participants will have access to the CRC mHealth intervention. |
| BG001 | Control Education | Control condition participants will receive information about colorectal cancer and screening developed by the Centers for Disease Control. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | Posted | Count of Participants | Participants | Month 6 |
|
from enrollment until end of follow-up, up to approximately 6 months
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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 | CRC mHealth Intervention | Experimental group participants will have access to the CRC mHealth intervention. |
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The planned primary outcome -EHR-verified CRC screening - could not be assessed due to failed record linkage. The clinic initially confirmed that name and phone number would suffice, but immediately before extraction FMCS required additional identifiers (e.g., date of birth) to match most records. Despite multiple attempts at alternative matching, linkage remained inadequate, leaving the EHR data unusable for the endpoint. We therefore report survey-based proxy composite outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Samantha Leaf, PhD | ISA Associates, Inc. | 7037390883 | sleaf@isagroup.com |
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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 | Oct 19, 2024 | Dec 10, 2025 | Prot_SAP_000.pdf |
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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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|
| Control | Behavioral | 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. |
|
| 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. |
| Month 6 |
| 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. | Month 6 |
| 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. | Month 6 |
| 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. | Month 6 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Percentage of Participants Reporting Yes to Receiving a Colorectal Cancer Screening Test | Participants responded to a multiple-choice item asking whether they had ever completed a recommended colorectal cancer screening (colonoscopy, FIT, FIT-DNA, virtual colonoscopy, or flexible sigmoidoscopy). Participants reported lifetime receipt at baseline. Response options were Yes/No/I'm not sure. | Number | percentage of participants screened |
|
| Perceived Severity of Colorectal Cancer | 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. | Mean | Standard Deviation | units on a scale |
|
| Perceived Susceptibility to Colorectal Cancer | 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. | Mean | Standard Deviation | units on a scale |
|
| Perceived Benefits to Colonoscopy | 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. | Mean | Standard Deviation | units on a scale |
|
| Perceived Benefits to Stool Test | 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. | Mean | Standard Deviation | units on a scale |
|
| Colorectal Cancer Knowledge | 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. | Mean | Standard Deviation | units on a scale |
|
Control condition participants will receive information about colorectal cancer and screening developed by the Centers for Disease Control. |
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Month 6 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Month 6 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Month 6 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Month 6 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Month 6 |
|
|
|
| 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. | Posted | Number | 95% Confidence Interval | Percentage of participants screened | baseline, 6-months |
|
|
|
| 0 |
| 63 |
| 0 |
| 63 |
| 0 |
| 63 |
| EG001 | Control Education | Control condition participants will receive information about colorectal cancer and screening developed by the Centers for Disease Control. | 0 | 65 | 0 | 65 | 0 | 65 |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |