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| Name | Class |
|---|---|
| Southcentral Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational text messaging | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Completed Colorectal Cancer Screening | Screening procedure documented in the electronic medical record | 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 | Six months |
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Inclusion Criteria:
Exclusion Criteria:
Eligibility determined in the electronic medical record, which reflects gender identity.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southcentral Foundation | Anchorage | Alaska | 99508 | United States |
Prior to sending the first electronic message, we re-queried the electronic health record and removed men who had completed colorectal screening in the interval between randomization and launching the trial.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | The control arm received usual care for colorectal cancer screening outreach, and did not receive any study-related electronic messages. |
| FG001 | Messages | This arm received electronic messages to promote colorectal cancer screening, but did not receive any notices about additional incentives. |
| FG002 | Gift Card | This arm received the same electronic messages as the "Messages" arm, and was additionally promised a $50 gift card if they completed colorectal screening by the target date. |
| FG003 | Raffle | This arm received the same electronic messages as the "Messages" arm, and were additionally promised they would be added to a raffle (~$200 prize value) if they completed screening before a target date. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | The control arm received usual care for colorectal cancer screening outreach, and did not receive any study-related electronic messages. |
| BG001 | Messages | This arm received electronic messages to promote colorectal cancer screening, but did not receive any notices about additional incentives. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Sex: Female, Male | This study only included patients identified as male in the electronic health record |
| 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 | Number of Participants Who Completed Colorectal Cancer Screening | Screening procedure documented in the electronic medical record | Posted | Count of Participants | Participants | Six months |
|
Six months, from date of randomization to end of follow-up
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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 | Control | The control arm received usual care for colorectal cancer screening outreach, and did not receive any study-related electronic messages. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clemma Muller | Washington State University | 612-327-7237 | clemma.muller@wsu.edu |
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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 | Jun 30, 2023 | Aug 11, 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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Parallel arm randomized controlled trial
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|
| BG002 | Gift Card | This arm received the same electronic messages as the "Messages" arm, and was additionally promised a $50 gift card if they completed colorectal screening by the target date. |
| BG003 | Raffle | This arm received the same electronic messages as the "Messages" arm, and were additionally promised they would be added to a raffle (~$200 prize value) if they completed screening before a target date. |
| BG004 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Race (NIH/OMB) | This study only included men identified as Alaska Native or American Indian in the electronic health record. | Count of Participants | Participants |
|
| Previous screening | Any previous colorectal cancer screening documented in the electronic health record | Count of Participants | Participants |
|
| Age, Customized | Count of Participants | Participants |
|
This arm received the same electronic messages as the "Messages" arm, and was additionally promised a $50 gift card if they completed colorectal screening by the target date. |
| OG003 | Raffle | This arm received the same electronic messages as the "Messages" arm, and were additionally promised they would be added to a raffle (~$200 prize value) if they completed screening before a target date. |
|
|
| Primary | Number of Participants Who Scheduled a Screening-related Visit | Pre-screening or screening visit scheduled in the electronic medical record during follow-up | Posted | Count of Participants | Participants | Six months |
|
|
|
| 0 |
| 250 |
| 0 |
| 250 |
| 0 |
| 250 |
| EG001 | Messages | This arm received electronic messages to promote colorectal cancer screening, but did not receive any notices about additional incentives. | 0 | 250 | 0 | 250 | 0 | 250 |
| EG002 | Gift Card | This arm received the same electronic messages as the "Messages" arm, and was additionally promised a $50 gift card if they completed colorectal screening by the target date. | 0 | 248 | 0 | 248 | 0 | 248 |
| EG003 | Raffle | This arm received the same electronic messages as the "Messages" arm, and were additionally promised they would be added to a raffle (~$200 prize value) if they completed screening before a target date. | 0 | 250 | 0 | 250 | 0 | 250 |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| No visit scheduled |
|