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CompletedNCT06436300Updated Aug 29, 2025Results posted

Colorectal Cancer Screening in Alaska Native Men

An interventional study of Motivational text messaging in Colorectal Cancer, sponsored by Washington State University. Completed at 1 site in United States. Open to male participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-29.

Sponsored by Washington State University · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Aug 2023, registered May 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
998
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
Male
01

Study 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, 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.

02

Conditions studied

  • Colorectal Cancer

Keywords

  • screening
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 998 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Washington State University is the lead sponsor of 82 studies on the registry; 16 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
998 participants (actual)

Study arms

  • No intervention
    Control

    Usual care arm receives established methods for scheduling colorectal cancer screening with clinic patients.

  • Experimental
    Messages only

    Receives motivational messages to promote colorectal cancer screening plus usual care.

    Behavioral: Motivational text messaging

  • Experimental
    Messages plus gift card

    Receives motivational messages to promote colorectal cancer screening, plus offer of a $50 gift card for completing screening, plus usual care.

    Behavioral: Motivational text messaging

  • Experimental
    Messages plus raffle

    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.

    Behavioral: Motivational text messaging

Interventions

  • BehavioralMotivational text messaging

    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.

06

What researchers measure

Primary outcomes

  1. Number of Participants Who Completed Colorectal Cancer Screening

    Screening procedure documented in the electronic medical record

    Time frame: Six months

  2. Number of Participants Who Scheduled a Screening-related Visit

    Pre-screening or screening visit scheduled in the electronic medical record during follow-up

    Time frame: Six months

07

Results

Posted Aug 29, 2025
Limitations and caveats
This study was limited to male patients at a single Tribal health care system in the Anchorage Metropolitan Area. Results may not generalize to other Alaska Native or American Indian people in other locations or settings. Colorectal cancer screening performed outside of the health care system would not be included in outcome data, but the vast majority of patients receive most or all their care from the Southcentral Foundation and we anticipate minimial misclassification of screening.

Participant flow

The trial obtained a waiver of consent, and no individuals were directly recruited or enrolled. Screening-eligible men who met all other criteria were identified in the electronic health record and randomly sampled for inclusion in the study cohort.

Participant flow — Overall Study
MilestoneControlMessagesGift CardRaffle
Started250250248250
Completed250250248250
Not completed0000

Outcome measures

PrimaryNumber of Participants Who Completed Colorectal Cancer Screening

Screening procedure documented in the electronic medical record

Time frame:
Six months
Reported as:
Count of participants · Participants
Number of Participants Who Completed Colorectal Cancer Screening
ParticipantsControlMessagesGift CardRaffle
Any screening documented11161819
No screening documented239234230231
PrimaryNumber of Participants Who Scheduled a Screening-related Visit

Pre-screening or screening visit scheduled in the electronic medical record during follow-up

Time frame:
Six months
Reported as:
Count of participants · Participants
Number of Participants Who Scheduled a Screening-related Visit
ParticipantsControlMessagesGift CardRaffle
Visit scheduled8201817
No visit scheduled242230230233

Adverse events

Collected over Six months, from date of randomization to end of follow-up. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Control0/250 (0%)0/250 (0%)0/250 (0%)
Messages0/250 (0%)0/250 (0%)0/250 (0%)
Gift Card0/248 (0%)0/248 (0%)0/248 (0%)
Raffle0/250 (0%)0/250 (0%)0/250 (0%)

Baseline characteristics

Sex: Female, Male
Sex: Female, Male(Participants)ControlMessagesGift CardRaffleTotal
Female00000
Male250250248250998
Race (NIH/OMB)
Race (NIH/OMB)(Participants)ControlMessagesGift CardRaffleTotal
American Indian or Alaska Native250250248250998
Asian00000
Native Hawaiian or Other Pacific Islander00000
Black or African American00000
White00000
More than one race00000
Unknown or Not Reported00000
Previous screening
Previous screening(Participants)ControlMessagesGift CardRaffleTotal
Previously screened36403640152
Not previously screened214210212210846
Age, Customized
Age, Customized(Participants)ControlMessagesGift CardRaffleTotal
40-44 years78828779326
45-49 years47474047181
50-54 years46403929154
55-59 years29292632116
60-65 years50525663221
08

Study locations

1 site
  • Southcentral Foundation
    Anchorage, Alaska 99508, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 30, 2023

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06436300
Lead sponsor
Washington State University
Collaborators
Southcentral Foundation
Responsible party
Clemma Muller (Associate Professor, Washington State University) — Principal investigator
First posted
May 31, 2024
Start date
Aug 1, 2023
Primary completion
Jan 31, 2024
Completion
Jan 31, 2024
Results posted
Aug 29, 2025
Last update
Aug 29, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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