A Culturally-adapted Colorectal Cancer Screening Decision Aid Designed for American Indians

NCT03569761 | Completed

• 1 other identifier: LCCC 1711
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Experts note that in order to continue reducing the US cancer burden, it is critical that investigators "more completely apply discoveries in cancer prevention we have already made." Thus, it is important to research strategies that aim to improve application of effective colorectal cancer (CRC) prevention and screening tests among underserved populations like American Indians (AI).CRC is the 2nd leading cause of cancer death among AI; yet, one of the most preventable and treatable cancers when detected early. Increased use of recommended CRC screening tests among men and women ages 50-75 have contributed to nearly 50% declines in US CRC mortality since 1990. However, recent evidence indicates AI have not observed equitable improvements. The investigators propose to build upon our experience addressing CRC screening in underserved populations and strong partnerships with North Carolina tribal partners to gain new insight about a patient-centered, culturally appropriate strategy to increase AI CRC screening.

Conditions

Colorectal Cancer

Keywords

colorectal cancer screening; decision aids; American Indians

Outcome Measures

Primary Outcomes (1)

• CRC screening intentions

  Measure of screening intent from prior CRC screening decision aid studies and assessed using a single categorical item regarding intentions to get CRC screening with four response options.

  Immediately after participant views their respective assigned video. Five (5) months following the encounter, a research assistant will call and administer a follow-up survey.

Secondary Outcomes (8)

• Knowledge

  Immediately after participant views their respective assigned video. Five (5) months following the encounter, a research assistant will call and administer a follow-up survey.

• Attitudes

  Immediately after participant views their respective assigned video. Five (5) months following the encounter, a research assistant will call and administer a follow-up survey.

• Perceived social norms

  Immediately after participant views their respective assigned video. Five (5) months following the encounter, a research assistant will call and administer a follow-up survey.

• Personal agency

  Immediately after participant views their respective assigned video. Five (5) months following the encounter, a research assistant will call and administer a follow-up survey.

• CRC screening preferences

  Immediately after participant views their respective assigned video. Five (5) months following the encounter, a research assistant will call and administer a follow-up survey.

Study Arms (2)

Decision Aid Video Intervention

EXPERIMENTAL

Participants randomized to the intervention group will view the AI culturally-adapted CRC screening decision aid in a private room at a RHCC clinic. The video will be viewed on an electronic tablet or laptop computer.

Behavioral: Colorectal Cancer Screening Decision Aid

Control

ACTIVE COMPARATOR

Participants randomized to the control group will view an attention-control video about food safety in a private room at a RHCC clinic. The video will be viewed on an electronic tablet or laptop computer. The investigators chose the attention-control video so that the structure of the control arm mirrors the intervention arm. The food safety topic was chosen to provide information that is reasonably salient to the control arm participants but that would not be likely to affect encounters with healthcare providers.

Behavioral: Control Group

Interventions

Colorectal Cancer Screening Decision Aid BEHAVIORAL

Information previously discussed in arm/group descriptions. There will be baseline, post-encounter, and 5-month follow-up assessments.

Decision Aid Video Intervention

Control Group BEHAVIORAL

Information previously discussed in arm/group descriptions. There will be baseline, post-encounter, and 5-month follow-up assessments. Information previously discussed in arm/group descriptions. There will be baseline, post-encounter, and 5-month follow-up assessments.

Control

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 50-75
• Self-identify as AI (from any tribe)
• Are not up-to-date with recommended screening in accordance with USPSTF guidelines.

You may not qualify if:

• Patients who have a personal or family history of CRC or adenomatous polyps or inherited genetic conditions that increase CRC risk (familial adenomatous polyposis, Lynch syndrome, Turcot syndrome, Peutz-Jeghers syndrome, or MUTYH-associated polyposis)
• Unable to speak English
• Severe cognitive, visual, or hearing impairment that would prevent decision aid viewing.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

Robeson Health Care Corporation

Lumberton, North Carolina, 28358, United States

Location

Related Publications (1)

• Frerichs L, Beasley C, Pevia K, Lowery J, Ferrari R, Bell R, Reuland D. Testing a Culturally Adapted Colorectal Cancer Screening Decision Aid Among American Indians: Results from a Pre-Post Trial. Health Equity. 2020 Apr 1;4(1):91-98. doi: 10.1089/heq.2019.0095. eCollection 2020.

  PMID: 32258960 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Leah Frerichs, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators will use a two-group randomized controlled trial to achieve our aims. Participants (n=120) will be randomized to view the AI culturally-adapted decision aid or an attention-control (i.e., food safety) video. The study flow diagram (Figure 2) indicates the recruitment, randomization, and assessment process.Our research to develop and evaluate the decision aid is approved by the Lumbee Tribal Council and the institutional review board (IRB) at the University of North Carolina at Chapel Hill.

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: June 26, 2018
• Study Start: August 1, 2017
• Primary Completion: September 25, 2018
• Study Completion: August 31, 2019
• Last Updated: December 20, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)