Improving Rates of Diagnostic Colonoscopy in Native Americans

NCT07115875 | Not Yet Recruiting DMC

• 1 other identifier: 16811
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer (CRC) is the second-leading cause of cancer death in both men and women in the United States. Compared to national averages, Native Americans (NA) endure a disproportionate burden of CRC incidence and CRC-specific mortality. The long-term goal of this collaboration is to enhance health equity through the reduction of CRC disparities in morbidity, mortality, stage-at-diagnosis, and survival among NA. To do so, the primary focus of these efforts has been to improve processes that increase uptake of home stool screening. The overall objective is to leverage these relationships and infrastructure to now focus on improving rates of timely diagnostic colonoscopy follow up after an abnormal home stool screening.

Conditions

CRC Screening; CRC (Colorectal Cancer)

Keywords

Mobile Health Technology; Telehealth; Digital Outreach

Outcome Measures

Primary Outcomes (1)

• Focus Group Strategy

  The investigators will use focus groups to co-develop a digital outreach intervention with Native Americans. Focus groups will help better understand how the investigators can support timely screening for colorectal cancer in this community

  6 months

Secondary Outcomes (1)

• Digital Outreach Intervention Strategies

  6 months

Study Arms (2)

mHealth Outreach and Telehealth Consultation

EXPERIMENTAL

The investigators will disseminate mHealth Outreach, using SMS texts with culturally relevant language and short videos that include personal narratives of patients and high-status Tribal members, to increase motivation to a schedule a diagnostic colonoscopy. Second, the investigators will try and overcome one refractory structural barrier to completing a diagnostic colonoscopy among Cheyenne and Arapaho Tribal members through telehealth. Cheyenne and Arapaho patients are required to visit the colonoscopy clinical facilities for both a pre-procedure appointment and the actual procedure. This process requires two round trips to a colonoscopy facility located in Lawton, OK, which is over 90 miles from the Clinton Indian Health Center. As a result, the investigators have proposed to test whether offering the pre-procedure as a telehealth consultation will overcome this transportation barriers.

Other: Digital Outreach

In Person Consultation

ACTIVE COMPARATOR

Participants randomized to In-Person Consultation will receive standard of care at IHS Lawton Hospital. Consultation includes a colonoscopy risk assessment (i.e., current medication use, risk of perforation and bleeding, ability to complete bowel prep).

Other: In Person consultation

Interventions

Digital Outreach OTHER

Digital outreach interventions through focus groups. The study is based on narrative interventions that highlights culturally sensitive and values among Native American communities.

mHealth Outreach and Telehealth Consultation

In Person consultation OTHER

In-Person Consultation will receive standard of care at IHS Lawton Hospital. Consultation includes a colonoscopy risk assessment (i.e., current medication use, risk of perforation and bleeding, ability to complete bowel prep).

In Person Consultation

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 45-75
• Live in Oklahoma
• Fluent in English
• Have access to email
• Identify as Native American or have a Certificate of Degree of Indian Blood

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

TSET Health Promotion Research Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

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

Study Officials

• Jordan Neil, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordan Neil, PhD

CONTACT

(405) 271-5046; jordan-neil@ouhsc.edu

Adam Alexander, PhD

CONTACT

(405) 271-5046; adam-alexander@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The two factors (Outreach Type and Consultation Type) will be crossed with one another to create a total of four experimental conditions.

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

US (1)