NCT06424197

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
799

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2024

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 22, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

1.1 years

First QC Date

May 16, 2024

Last Update Submit

August 5, 2025

Conditions

Keywords

Colorectcal Cancer Screening Targeted Message Intervention

Outcome Measures

Primary Outcomes (1)

  • FIT Kit request

    FIT Kit request

    Immediately after survey

Secondary Outcomes (1)

  • FIT Kit return

    3 months

Study Arms (4)

Norm Based Messages

EXPERIMENTAL

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

Other: Racial group-targeted messages

Fear Reduction Message

EXPERIMENTAL

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

Other: Racial group-targeted messages

Commitment

EXPERIMENTAL

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

Other: Explicit Commitment

Control

NO INTERVENTION

Participants receive no health messages.

Interventions

Colorectal cancer screening messages targeted towards participants racial group.

Fear Reduction MessageNorm Based Messages

Indicate explicit commitment to return at home screening kit.

Commitment

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oakland University

Rochester, Michigan, 48309, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Mark Manning, PhD

    Oakland University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2024

First Posted

May 22, 2024

Study Start

March 1, 2023

Primary Completion

April 23, 2024

Study Completion

August 31, 2024

Last Updated

August 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations