Colorectal CancerNCT06436300
Colorectal Cancer Screening in Alaska Native Men
A study testing Motivational text messaging in people with Colorectal Cancer, run by Washington State University at 1 site in United States.
Trial summary
Alaska Native men have the highest rates of colorectal cancer incidence and mortality in the US. Screening can prevent disease and improve survival. A previous study tested text messages to increase colorectal cancer screening in Alaska Native patients of the Southcentral Foundation healthcare system in Anchorage… Read more about this study
- Who is it for?
- Ages 40 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Motivational text messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 998 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 31 Jan 2024
- 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 40 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Alaska Native or American Indian racial identity
- Male gender identity
- Active patient of the Southcentral Foundation in Anchorage, Alaska
- Empanelled to primary care provider in the Anchorage or local Valley area
- Eligible for routine preventive colorectal cancer screening
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increasing Colorectal Cancer Screening in Alaska Native Men
Alaska Native men have the highest rates of colorectal cancer incidence and mortality in the US. Screening can prevent disease and improve survival. A previous study tested text messages to increase colorectal cancer screening in Alaska Native patients of the Southcentral Foundation healthcare system in Anchorage, Alaska. The intervention improved screening by 50% in women, but it had no effect in men. The current study aimed to culturally tailor the intervention for Alaska Native Men, and to test it with a randomized controlled trial among patients at the Southcentral Foundation.
Read the detailed description
Alaska Native men have higher colorectal cancer (CRC) incidence and mortality than any other US racial or ethnic group. Screening can prevent CRC and improve treatment outcomes by detecting disease in early stages, but Alaska Native men also have low CRC screening uptake. Colonoscopy is the most accurate CRC screening method and results in the most years of life saved. It only requires rescreening every 10 years, but it is a clinic- based procedure and needs extensive preparation. Other screening options include home-based tests that detect blood in the stool and require rescreening every year. More recently, a home-based method has been developed that tests stool for DNA indicative of CRC and requires rescreening every 3 years. Current guidelines recommend CRC screening for average risk adults starting between ages 45-50, but people at higher risk should start at younger ages. Many interventions have been developed to promote CRC screening. Among these, interventions that use text messaging or other electronic health messages to reach people outside of the clinical setting have shown promise for improving CRC screening. In a previous study, the research team developed an intervention that sends up to 3 text messages to Alaska Native people patients of the Southcentral Foundation (SCF) healthcare system in Anchorage, Alaska. The intervention was tested in a randomized controlled trial with 2,386 Alaska Native SCF patients ages 40-75. The intervention increased CRC screening by 50% in women, but it had no effect in men. The current study used a theory-based approach to culturally tailor the previous text message intervention for Alaska Native men. Investigators conducted a randomized trial to test the effectiveness of the tailored intervention with 998 Alaska Native men ages 40-75 who were active patients at SCF. Eligible men were identified from the electronic medical record and randomized in equal proportions to the control condition or to one of three intervention arms (messages only, messages plus gift card incentive, messages plus raffle incentive). The primary outcomes were completed CRC screening documented in the electronic medical record within 6 months of sending the first text message, and any scheduled visit for pre-screening or screening documented in the medical record during follow-up. The study obtained a waiver of consent, and no individuals were directly recruited or enrolled in the study. Follow-up was entirely ascertained through the electronic medical record, and cohort attrition was not applicable.
- Conditions
- Colorectal Cancer
- Being tested
- Motivational text messaging
- Keywords
- screening
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational text messagingBehavioural
Intervention sends up to 4 motivational messages by text or email to Alaska Native men who are active patients and due for colorectal cancer screening. Incentive arms include promise of a $50 gift card or entry into a raffle for prize worth about $200 if they complete screening.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual care arm receives established methods for scheduling colorectal cancer screening with clinic patients. |
| Messages only | Experimental | Receives motivational messages to promote colorectal cancer screening plus usual care. Receives: Behavioral: Motivational text messaging |
| Messages plus gift card | Experimental | Receives motivational messages to promote colorectal cancer screening, plus offer of a $50 gift card for completing screening, plus usual care. Receives: Behavioral: Motivational text messaging |
| Messages plus raffle | Experimental | Receives motivational messages to promote colorectal cancer screening, plus offer of entry into a raffle for a prize worth approximately $200 if they complete screening, plus usual care. Receives: Behavioral: Motivational text messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Completed Colorectal Cancer Screening
Screening procedure documented in the electronic medical record
Measured: Six months
Number of Participants Who Scheduled a Screening-related Visit
Pre-screening or screening visit scheduled in the electronic medical record during follow-up
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start1 Aug 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
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
- Model description
- Parallel arm randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 998 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Collaborators
- Southcentral Foundation
- Responsible party
- Principal investigator, Clemma Muller, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436300
- Sponsor's protocol ID
- R21NR019362
- Status last verified
- Aug 2025
- First submitted
- 24 May 2024
- Last updated
- 29 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Colorectal Cancer Screening in Alaska Native Men
- ClinicalTrials.gov ID
- NCT06436300
- Acronym / sponsor ID
- R21NR019362
- Conditions
- Colorectal Cancer
- Keywords
- screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 998 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Collaborators
- Southcentral Foundation
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 31 May 2024 (actual)
- Results
- Posted 29 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Alaska Native men have the highest rates of colorectal cancer incidence and mortality in the US. Screening can prevent disease and improve survival. A previous study tested text messages to increase colorectal cancer screening in Alaska Native patients of the Southcentral Foundation healthcare system in Anchorage, Alaska. The intervention improved screening by 50% in women, but it had no effect in men. The current study aimed to culturally tailor the intervention for Alaska Native Men, and to test it with a randomized controlled trial among patients at the Southcentral Foundation.
Detailed description
Alaska Native men have higher colorectal cancer (CRC) incidence and mortality than any other US racial or ethnic group. Screening can prevent CRC and improve treatment outcomes by detecting disease in early stages, but Alaska Native men also have low CRC screening uptake. Colonoscopy is the most accurate CRC screening method and results in the most years of life saved. It only requires rescreening every 10 years, but it is a clinic- based procedure and needs extensive preparation. Other screening options include home-based tests that detect blood in the stool and require rescreening every year. More recently, a home-based method has been developed that tests stool for DNA indicative of CRC and requires rescreening every 3 years. Current guidelines recommend CRC screening for average risk adults starting between ages 45-50, but people at higher risk should start at younger ages. Many interventions have been developed to promote CRC screening. Among these, interventions that use text messaging or other electronic health messages to reach people outside of the clinical setting have shown promise for improving CRC screening. In a previous study, the research team developed an intervention that sends up to 3 text messages to Alaska Native people patients of the Southcentral Foundation (SCF) healthcare system in Anchorage, Alaska. The intervention was tested in a randomized controlled trial with 2,386 Alaska Native SCF patients ages 40-75. The intervention increased CRC screening by 50% in women, but it had no effect in men. The current study used a theory-based approach to culturally tailor the previous text message intervention for Alaska Native men. Investigators conducted a randomized trial to test the effectiveness of the tailored intervention with 998 Alaska Native men ages 40-75 who were active patients at SCF. Eligible men were identified from the electronic medical record and randomized in equal proportions to the control condition or to one of three intervention arms (messages only, messages plus gift card incentive, messages plus raffle incentive). The primary outcomes were completed CRC screening documented in the electronic medical record within 6 months of sending the first text message, and any scheduled visit for pre-screening or screening documented in the medical record during follow-up. The study obtained a waiver of consent, and no individuals were directly recruited or enrolled in the study. Follow-up was entirely ascertained through the electronic medical record, and cohort attrition was not applicable.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Parallel arm randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual care arm receives established methods for scheduling colorectal cancer screening with clinic patients. |
| Messages only | Experimental | Behavioral: Motivational text messagingReceives motivational messages to promote colorectal cancer screening plus usual care. |
| Messages plus gift card | Experimental | Behavioral: Motivational text messagingReceives motivational messages to promote colorectal cancer screening, plus offer of a $50 gift card for completing screening, plus usual care. |
| Messages plus raffle | Experimental | Behavioral: Motivational text messagingReceives motivational messages to promote colorectal cancer screening, plus offer of entry into a raffle for a prize worth approximately $200 if they complete screening, plus usual care. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Alaska Native or American Indian racial identity
- Male gender identity
- Active patient of the Southcentral Foundation in Anchorage, Alaska
- Empanelled to primary care provider in the Anchorage or local Valley area
- Eligible for routine preventive colorectal cancer screening
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Motivational text messagingIntervention sends up to 4 motivational messages by text or email to Alaska Native men who are active patients and due for colorectal cancer screening. Incentive arms include promise of a $50 gift card or entry into a raffle for prize worth about $200 if they complete screening. | Behavioural | Messages only, Messages plus gift card, Messages plus raffle |
Primary outcome
Number of Participants Who Completed Colorectal Cancer Screening
Time frame: Six months
Screening procedure documented in the electronic medical record
Number of Participants Who Scheduled a Screening-related Visit
Time frame: Six months
Pre-screening or screening visit scheduled in the electronic medical record during follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational text messaging in people with Colorectal Cancer, run by Washington State University 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 5 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 29 Aug 2025. 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 29 Aug 2025). 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?
Number of Participants Who Completed Colorectal Cancer Screening (time frame: Six months). 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?
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 29 Aug 2025.