## Protocol Section
### Identification Module
**NCT ID:** NCT06424197

**Brief Title:** Colorectal Cancer Screening Intervention Study

**Official Title:** Colorectal Screening Fear-reduction and Racially-targeted Norm Messaging Entreaties to Increase Colorectal Cancer Screening Rates Among African Americans

#### Organization Study ID Info
**ID:** IRB-FY2023-3
#### Organization
**Class:** OTHER
**Full Name:** Oakland University
#### Secondary ID Infos
**ID:** R21MD016506
**Link:** https://reporter.nih.gov/quickSearch/R21MD016506
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2024-08-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-04-23

**Type:** ACTUAL

#### Start Date
**Date:** 2023-10-10

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institutes of Health (NIH)

**Class:** NIH

**Name:** National Institute on Minority Health and Health Disparities (NIMHD)

#### Lead Sponsor

**Class:** OTHER

**Name:** Oakland University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Colorectal cancer (CRC) is one of the leading causes of cancer mortality in the United States, and African Americans (AfAms) still fare worse in CRC incidence and mortality compared to European Americans (EuAms). We propose to examine whether combining both fear-reduction and racially-targeted norm-based messages will increase at-home stool-based CRC screening receptivity and uptake for all African American regardless of level of racial identity. Given low return rates of at-home screening kits, we will also explore whether making an explicit commitment to return screening kits is associated with increased kit returns.

**Detailed Description:** Colorectal cancer (CRC) is one of the leading causes of cancer mortality in the United States, and African Americans (AfAms) still fare worse in CRC incidence and mortality compared to European Americans (EuAms).Interventions to increase CRC screening rates among AfAms are instrumental to address the disparities in CRC incidence and mortality. Despite literature indicating that AfAms' fears (e.g., of colonoscopy procedures or cancer diagnosis) serve as barriers to CRC screening, no interventions have used theory-guided methods to directly target fear-based beliefs. Additionally, no research has examined the extent to which racial identity moderates the effects of racially targeted messaging, despite the ubiquity of using targeted health messaging entreaties among minority groups. This is particularly relevant given our work showing that racially-targeted screening entreaties increased CRC screening intentions among AfAms who identified less strongly, but depressed those intentions among AfAms who identified more strongly with their racial group. Lack of focus on other salient CRC screening barriers may have been off-putting to highly identified African Americans. We propose to examine whether combining both fear-reduction and racially-targeted norm-based messages will increase at-home stool-based CRC screening receptivity and uptake for all African American regardless of level of racial identity. Given low return rates of at-home screening kits, we will also explore whether making an explicit commitment to return screening kits is associated with increased kit returns.

Aim 1: To develop and refine a fear-reduction intervention guided by the theory of planned behavior and by published literature, in conjunction with AfAm community experts.

Aim 2: To examine whether the fear-reduction entreaty increases receptivity to, and uptake of at-home CRC screening when coupled with racially-targeted norm-based messages.

Aim 3: To examine the moderating roles of racial identity and perceived CRC risk on the effects of fear-reduction and racially-targeted norm-based messaging entreaties.

Aim 4: We will explore whether participants who make explicit commitments to return FIT Kits return them at a higher rate compared to those who do not make such commitments.

### Conditions Module

**Conditions:**

- Colorectal Cancer

**Keywords:**

- Colorectcal Cancer Screening Targeted Message Intervention

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** FACTORIAL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** SCREENING

#### Enrollment Info

**Count:** 799

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** One of 3 messaging entreaties based on normative perceptions of colorectal cancer screening, and one no norm-based messaging arm.

**Intervention Names:**

- Other: Racial group-targeted messages

**Label:** Norm Based Messages

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants randomized to receive (or not receive) messaging entreaty to address colorectal cancer screening fears.

**Intervention Names:**

- Other: Racial group-targeted messages

**Label:** Fear Reduction Message

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Participants randomized to indicate explicit commitment to return FIT Kits for processing.

**Intervention Names:**

- Other: Explicit Commitment

**Label:** Commitment

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Participants receive no health messages.

**Label:** Control

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Fear Reduction Message

- Norm Based Messages

**Description:** Colorectal cancer screening messages targeted towards participants racial group.

**Name:** Racial group-targeted messages

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Commitment

**Description:** Indicate explicit commitment to return at home screening kit.

**Name:** Explicit Commitment

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** FIT Kit request

**Measure:** FIT Kit request

**Time Frame:** Immediately after survey

#### Secondary Outcomes

**Description:** Mailing completed FIT Kit to lab for processing

**Measure:** FIT Kit return

**Time Frame:** 3 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

African American Overdue to colorectal cancer screening Has primary care physician Not at high risk for colorectal cancer

Exclusion Criteria:

Not meeting inclusion criteria

**Healthy Volunteers:** True

**Maximum Age:** 80 Years

**Minimum Age:** 45 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Rochester

**Country:** United States

**Facility:** Oakland University

**State:** Michigan

**Zip:** 48309

#### Overall Officials

**Official 1:**

**Affiliation:** Oakland University

**Name:** Mark Manning, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## 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
