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

A study testing CRC mHealth in people with Colorectal Cancer, run by ISA Associates, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 45 to 75 years, men onlyHealthy volunteers can take part
Conditions the study is for: Colorectal Cancer
What is being tested?: CRC mHealth
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 128 participants
Where: 1 siteUnited States
Study dates: 8 Dec 2023to 1 May 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 75 years
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

personal history of colorectal cancer

Trial locations and contacts

1 site in 1 country.

United States1 site

ISA Associates, Inc.
Alexandria, Virginia, 22314

Other trials in United States

About this study

Official title: Reducing Colorectal Cancer Health Disparities: An mHealth Intervention to Improve Screening Among African American Men

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.

Conditions: Colorectal Cancer
Being tested: CRC mHealth, Control
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CRC mHealthBehavioural
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.
ControlBehavioural
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.

Study groups in NCT06052202
Study group	Role	What they receive
CRC mHealth intervention	Experimental	Experimental group participants will have access to the CRC mHealth intervention. Receives: Behavioral: CRC mHealth
Control Education	Active comparator	Control condition participants will receive information about colorectal cancer and screening developed by the Centers for Disease Control. Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: baseline, 6-months

Secondary outcomes (5)

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.
Measured: Month 6
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Dec 20231 May 2025

First posted25 Sep 2023
Study start8 Dec 2023
Primary completion1 May 2025
Study completion1 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 128 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06052202
Sponsor's protocol ID: R44CA246899
Status last verified: Dec 2025
First submitted: 18 Sep 2023
Last updated: 2 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer

All Colorectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reducing Colorectal Cancer Health Disparities: An mHealth Intervention to Improve Screening Among African American Men
ClinicalTrials.gov ID: NCT06052202
Acronym / sponsor ID: R44CA246899
Conditions: Colorectal Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 128 participants (actual)
Lead sponsor: ISA Associates, Inc.University, hospital or other
Study start: 8 Dec 2023 (actual)
Primary completion: 1 May 2025 (actual)
Study completion: 1 May 2025 (actual)
First posted: 25 Sep 2023 (actual)
Results: Posted 2 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
CRC mHealth intervention	Experimental	Behavioral: CRC mHealthExperimental group participants will have access to the CRC mHealth intervention.
Control Education	Active comparator	Behavioral: ControlControl condition participants will receive information about colorectal cancer and screening developed by the Centers for Disease Control.

Who may qualify

Ages: 45 to 75 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (1 listed)

personal history of colorectal cancer

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CRC mHealthParticipants 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.	Behavioural	CRC mHealth intervention
ControlParticipants 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.	Behavioural	Control Education

Primary outcome

Percentage of Participants Who Received a Colorectal Cancer Screening Test
Time frame: 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
Time frame: 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.

5 secondary outcomes

Perceived Severity of Colorectal Cancer at Month 6
Time frame: Month 6
Perceived Susceptibility to Colorectal Cancer at Month 6
Time frame: Month 6
Perceived Benefits to Colonoscopy at Month 6
Time frame: Month 6
Perceived Benefits to Stool Test at Month 6
Time frame: Month 6
Colorectal Cancer Knowledge at Month 6
Time frame: Month 6

Results and safety

Results posted to the registry on 2 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CRC mHealth Intervention	63	47
Control Education	65	47

Primary outcome: Percentage of Participants Who Received a Colorectal Cancer Screening Test

Time frame: Month 6. Count of participants. Unit: Participants

Measure	CRC mHealth Intervention n = 63	Control Education n = 65
Value	2	2

Primary outcome: Percentage of Participants Reporting Yes to Receiving a Colorectal Cancer Screening Test

Time frame: baseline, 6-months. Number (95% Confidence Interval). Unit: Percentage of participants screened

Measure	CRC mHealth Intervention n = 47	Control Education n = 47
Value	40.4 (27.6 to 54.7)	17.0 (8.9 to 30.1)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: from enrollment until end of follow-up, up to approximately 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CRC mHealth Intervention	0 of 63 (0%)	0 of 63 (0%)	0 of 63
Control Education	0 of 65 (0%)	0 of 65 (0%)	0 of 65

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Colorectal Cancer

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Samantha L Leaf, Ph.D. principal investigator

ISA Associates

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CRC mHealth in people with Colorectal Cancer, run by ISA Associates, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Received a Colorectal Cancer Screening Test (time frame: Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06052202.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.