Trial Outcomes & Findings for A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men (NCT NCT06052202)

NCT ID: NCT06052202

Last Updated: 2026-01-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

128 participants

Primary outcome timeframe

Month 6

Results posted on

2026-01-02

Participant Flow

Participant milestones

Participant milestones
Measure
CRC mHealth Intervention
Experimental group participants will have access to the CRC mHealth intervention.
Control Education
Control condition participants will receive information about colorectal cancer and screening developed by the Centers for Disease Control.
Overall Study
STARTED
63
65
Overall Study
COMPLETED
47
47
Overall Study
NOT COMPLETED
16
18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
CRC mHealth Intervention
n=63 Participants
Experimental group participants will have access to the CRC mHealth intervention.
Control Education
n=65 Participants
Control condition participants will receive information about colorectal cancer and screening developed by the Centers for Disease Control.
Total
n=128 Participants
Total of all reporting groups
Age, Continuous
56.2 years
STANDARD_DEVIATION 7.2 • n=228 Participants
56.2 years
STANDARD_DEVIATION 6.8 • n=115 Participants
56.2 years
STANDARD_DEVIATION 6.9 • n=343 Participants
Sex: Female, Male
Female
0 Participants
n=228 Participants
0 Participants
n=115 Participants
0 Participants
n=343 Participants
Sex: Female, Male
Male
63 Participants
n=228 Participants
65 Participants
n=115 Participants
128 Participants
n=343 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=228 Participants
0 Participants
n=115 Participants
0 Participants
n=343 Participants
Race (NIH/OMB)
Asian
0 Participants
n=228 Participants
0 Participants
n=115 Participants
0 Participants
n=343 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=228 Participants
0 Participants
n=115 Participants
0 Participants
n=343 Participants
Race (NIH/OMB)
Black or African American
61 Participants
n=228 Participants
62 Participants
n=115 Participants
123 Participants
n=343 Participants
Race (NIH/OMB)
White
0 Participants
n=228 Participants
0 Participants
n=115 Participants
0 Participants
n=343 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=228 Participants
1 Participants
n=115 Participants
2 Participants
n=343 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=228 Participants
2 Participants
n=115 Participants
3 Participants
n=343 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=228 Participants
1 Participants
n=115 Participants
1 Participants
n=343 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
63 Participants
n=228 Participants
64 Participants
n=115 Participants
127 Participants
n=343 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=228 Participants
0 Participants
n=115 Participants
0 Participants
n=343 Participants
Percentage of Participants Reporting Yes to Receiving a Colorectal Cancer Screening Test
52.4 percentage of participants screened
n=228 Participants
49.2 percentage of participants screened
n=115 Participants
50.8 percentage of participants screened
n=343 Participants
Perceived Severity of Colorectal Cancer
3.22 units on a scale
STANDARD_DEVIATION 0.75 • n=228 Participants
3.03 units on a scale
STANDARD_DEVIATION 0.78 • n=115 Participants
3.12 units on a scale
STANDARD_DEVIATION 0.77 • n=343 Participants
Perceived Susceptibility to Colorectal Cancer
2.77 units on a scale
STANDARD_DEVIATION 0.60 • n=228 Participants
2.67 units on a scale
STANDARD_DEVIATION 0.83 • n=115 Participants
2.72 units on a scale
STANDARD_DEVIATION 0.73 • n=343 Participants
Perceived Benefits to Colonoscopy
4.08 units on a scale
STANDARD_DEVIATION 0.53 • n=228 Participants
4.03 units on a scale
STANDARD_DEVIATION 0.54 • n=115 Participants
4.06 units on a scale
STANDARD_DEVIATION 0.54 • n=343 Participants
Perceived Benefits to Stool Test
3.86 units on a scale
STANDARD_DEVIATION 0.51 • n=228 Participants
3.95 units on a scale
STANDARD_DEVIATION 0.55 • n=115 Participants
3.91 units on a scale
STANDARD_DEVIATION 0.53 • n=343 Participants
Colorectal Cancer Knowledge
13.33 units on a scale
STANDARD_DEVIATION 1.76 • n=228 Participants
13.37 units on a scale
STANDARD_DEVIATION 1.80 • n=115 Participants
13.35 units on a scale
STANDARD_DEVIATION 1.77 • n=343 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
CRC mHealth Intervention
n=63 Participants
Experimental group participants will have access to the CRC mHealth intervention.
Control Education
n=65 Participants
Control condition participants will receive information about colorectal cancer and screening developed by the Centers for Disease Control.
Percentage of Participants Who Received a Colorectal Cancer Screening Test
2 Participants
2 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
CRC mHealth Intervention
n=47 Participants
Experimental group participants will have access to the CRC mHealth intervention.
Control Education
n=47 Participants
Control condition participants will receive information about colorectal cancer and screening developed by the Centers for Disease Control.
Percentage of Participants Reporting Yes to Receiving a Colorectal Cancer Screening Test
40.4 Percentage of participants screened
Interval 27.6 to 54.7
17.0 Percentage of participants screened
Interval 8.9 to 30.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
CRC mHealth Intervention
n=47 Participants
Experimental group participants will have access to the CRC mHealth intervention.
Control Education
n=47 Participants
Control condition participants will receive information about colorectal cancer and screening developed by the Centers for Disease Control.
Perceived Severity of Colorectal Cancer at Month 6
2.82 units on a scale
Standard Deviation 0.76
2.59 units on a scale
Standard Deviation 0.61

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
CRC mHealth Intervention
n=47 Participants
Experimental group participants will have access to the CRC mHealth intervention.
Control Education
n=47 Participants
Control condition participants will receive information about colorectal cancer and screening developed by the Centers for Disease Control.
Perceived Susceptibility to Colorectal Cancer at Month 6
2.82 units on a scale
Standard Deviation 0.76
2.59 units on a scale
Standard Deviation 0.61

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
CRC mHealth Intervention
n=47 Participants
Experimental group participants will have access to the CRC mHealth intervention.
Control Education
n=47 Participants
Control condition participants will receive information about colorectal cancer and screening developed by the Centers for Disease Control.
Perceived Benefits to Colonoscopy at Month 6
4.23 units on a scale
Standard Deviation 0.51
4.11 units on a scale
Standard Deviation 0.54

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
CRC mHealth Intervention
n=47 Participants
Experimental group participants will have access to the CRC mHealth intervention.
Control Education
n=47 Participants
Control condition participants will receive information about colorectal cancer and screening developed by the Centers for Disease Control.
Perceived Benefits to Stool Test at Month 6
3.91 units on a scale
Standard Deviation 0.52
4.06 units on a scale
Standard Deviation 0.52

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
CRC mHealth Intervention
n=47 Participants
Experimental group participants will have access to the CRC mHealth intervention.
Control Education
n=47 Participants
Control condition participants will receive information about colorectal cancer and screening developed by the Centers for Disease Control.
Colorectal Cancer Knowledge at Month 6
13.70 score on a scale
Standard Deviation 1.49
13.17 score on a scale
Standard Deviation 1.43

Adverse Events

CRC mHealth Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control Education

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Samantha Leaf, PhD

ISA Associates, Inc.

Phone: 7037390883

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place