## Protocol Section
### Identification Module
**NCT ID:** NCT06436300

**Brief Title:** Colorectal Cancer Screening in Alaska Native Men

**Official Title:** Increasing Colorectal Cancer Screening in Alaska Native Men

#### Organization Study ID Info
**ID:** R21NR019362
**Link:** https://reporter.nih.gov/quickSearch/R21NR019362
**Type:** NIH
#### Organization
**Class:** OTHER
**Full Name:** Washington State University
### Status Module
#### Completion Date
**Date:** 2024-01-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-24

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-01-31

**Type:** ACTUAL

#### Start Date
**Date:** 2023-08-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Southcentral Foundation

#### Lead Sponsor

**Class:** OTHER

**Name:** Washington State University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Alaska Native men have the highest rates of colorectal cancer incidence and mortality in the US. Screening can prevent disease and improve survival. We previously developed an intervention that uses 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. We propose to culturally tailor the intervention for Alaska Native Men, and to test it with a randomized controlled trial among 600 patients at the Southcentral Foundation. This will be the first trial of an intervention designed to increase colorectal cancer screening in Alaska Native men.

**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, our 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. We tested the intervention 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. In the current implementation study, we propose a theory-based approach to culturally tailor the existing text message intervention for Alaska Native men. We will use surveys and focus groups with SCF patients, and key informant interviews with SCF healthcare providers, to assess barriers and facilitators to optimize colorectal cancer screening in Alaska Native men. We anticipate that revisions will include changing the content and frequency of the text messages, and promoting home-based stool DNA screening in addition to colonoscopy. We will then test the effectiveness of the tailored intervention with 600 Alaska Native men ages 40-75 who are active patients at SCF. Eligible men will be identified from the electronic medical record and randomized in equal proportions to the intervention or usual care control conditions. The primary outcome is CRC screening completed within 6 months of sending the first text message. Secondary outcomes include clinical findings and follow-up procedures associated with screening. All data will be collected from the electronic medical record, and we will obtain a waiver of consent for direct patient recruitment. Follow-up interviews will assess patient response to the intervention. If effective, this study has implications for increasing CRC screening in men from other racial and ethnic minority groups who experience CRC disparities.

Public Health Relevance Statement

### Conditions Module

**Conditions:**

- Colorectal Cancer

**Keywords:**

- screening

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Parallel arm randomized controlled trial

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SCREENING

#### Enrollment Info

**Count:** 998

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Label:** Control

**Type:** NO_INTERVENTION

#### Arm Group 2

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

**Intervention Names:**

- Behavioral: Motivational text messaging

**Label:** Messages only

**Type:** EXPERIMENTAL

#### Arm Group 3

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

**Intervention Names:**

- Behavioral: Motivational text messaging

**Label:** Messages plus gift card

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** 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.

**Intervention Names:**

- Behavioral: Motivational text messaging

**Label:** Messages plus raffle

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Messages only

- Messages plus gift card

- Messages plus raffle

**Description:** 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.

**Name:** Motivational text messaging

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Screening procedure documented in the electronic medical record

**Measure:** Colorectal cancer screening

**Time Frame:** Six months

**Description:** Scheduling colonoscopy pre-op appointment

**Measure:** Screening behavior

**Time Frame:** Six months

### Eligibility Module

**Eligibility Criteria:** 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:

* None

**Gender Based:** True

**Gender Description:** Eligibility determined in the electronic medical record, which reflects gender identity.

**Healthy Volunteers:** True

**Maximum Age:** 75 Years

**Minimum Age:** 40 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Anchorage

**Country:** United States

**Facility:** Southcentral Foundation

**State:** Alaska

**Zip:** 99508

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007414

- Term: Intestinal Neoplasms

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000003108

- Term: Colonic Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000012002

- Term: Rectal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M17890

- Name: Colorectal Neoplasms

- Relevance: HIGH

- As Found: Colorectal Cancer

- ID: M10448

- Name: Intestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6336

- Name: Colonic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14844

- Name: Rectal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000015179

- Term: Colorectal Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
