Enhancing Prevention Pathways Toward Tribal Colorectal Health

NCT02882620 | Completed DMC

• 2 other identifiers: 14-363R01CA192967
• Study Type: interventional
• Target: 1,788
• Locations: 1 country
• Sites: 1

Brief Summary

Recent improvements in colorectal cancer (CRC) incidence, mortality, stage at diagnosis, and survival in the general U.S. population have been attributed to routine screening with prompt removal of polyps, early detection, and timely and appropriate treatment. American Indians/Alaska Natives (AI/ANs) have not experienced improvements in CRC related outcomes and are significantly less likely than non-Hispanic Whites to receive recommended CRC screening. The purpose of this three-arm randomized controlled trial is to determine the efficacy of interventions designed to enhance CRC screening. The study also uses mixed methods to finalize the intervention and to determine promoters and barriers of screening. The study also conducts process evaluation to determine cost-effectiveness of the interventions, fidelity of study implementation, and to develop plans to sustain and scale-up the intervention model. The study will determine the efficacy of serially implemented interventions of graded intensity for increasing CRC screening using the fecal immunochemical test (FIT) in accordance to recommended guidelines among average risk American Indians (AIs) aged 45-75 residing on reservations in rural Southwestern U.S. Serial implementation refers to offering routine screening, irrespective of response to an earlier invitation, in concordance with guidelines which recommend annual FIT testing between ages 45-75. The FIT is most appropriate because it is an approved, high sensitivity fecal occult blood test and is available at Indian Health Service (IHS) and tribal health facilities where resources to provide screening colonoscopy are limited. The study is a collaborative effort between the Albuquerque Area Indian Health Board (100% Indian-owned and operated), six Pueblo Tribes in rural Southwestern U.S., and the University of New Mexico. Findings from this research could lead to an immediate increase in CRC screening and ultimately reduce CRC burden among AIs, thus addressing national and tribal priorities of reducing CRC disparities among AIs.

Conditions

Colorectal Neoplasm

Keywords

Colorectal neoplasm; Screening; Patient navigation; Randomized controlled trial; Cost-benefit analysis; Health behavior; Health equity; American Indians; Community-based participatory research; Fecal occult blood test

Outcome Measures

Primary Outcomes (1)

• Annual Completion of the FIT Kit

  The interventions are delivered over 3 12-month cycles. The primary outcome will be measured within 3 12-month periods. Cycle 1: T1-T12 months; Cycle 2: T13-T24 months; Cycle 3: T25-T36 months

Secondary Outcomes (6)

• Change in Knowledge

  Baseline (T0 month), Posttest 1 (T1-T12 months), Posttest 2 (T13-T24 months), Posttest 3 (T25-T36 months)

• Change in Attitudes

  Baseline (T0 month), Posttest 1 (T1-T12 months), Posttest 2 (T13-T24 months), Posttest 3 (T25-T36 months)

• Change in Perceived Control

  Baseline (T0 month), Posttest 1 (T1-T12 months), Posttest 2 (T13-T24 months), Posttest 3 (T25-T36 months)

• Change in Perceived Susceptibility

  Baseline (T0 month), Posttest 1 (T1-T12 months), Posttest 2 (T13-T24 months), Posttest 3 (T25-T36 months)

• Change in Perceived Severity

  Baseline (T0 month), Posttest 1 (T1-T12 months), Posttest 2 (T13-T24 months), Posttest 3 (T25-T36 months)

Study Arms (3)

High Intensity (Group 1)

EXPERIMENTAL

The high intensity intervention includes: navigated outreach, with four in-depth education outreach sessions; mailed FIT; education material; and follow-up mailed reminders (Group 1). The navigated outreach includes one-on-one information dissemination about CRC, importance of adhering to CRC screening guidelines, identification and solutions to screening barriers, motivation, self-efficacy and comprehension on how to complete the FIT kit, and gathering (if requested) and return of the completed FIT to the laboratory. The educational material (brochure) is specially developed and culturally tailored for the six Tribes recruited for this study. The FIT kit used is the Polymedco OC FIT-CHECK® OC-Light test, which is a single collection test that meets USPSTF's guidelines.

Behavioral: High Intensity (Group 1)

Medium Intensity (Group 2)

EXPERIMENTAL

The medium intensity intervention includes: mailed FIT; education material; and follow-up mailed reminders (Group 2). The educational material (brochure) is specially developed and culturally tailored for the six Tribes recruited for this study. The FIT kit used is the Polymedco OC FIT-CHECK® OC-Light test, which is a single collection test that meets USPSTF's guidelines.

Behavioral: Medium Intensity (Group 2)

Reference Group (Group 3)

EXPERIMENTAL

The reference group (Group 3), per IHS guidelines and current standard of care at participating IHS facilities, receives usual care (ie, screening recommendation and a FIT kit at a clinic visit). The FIT kit used is the Polymedco OC FIT-CHECK® OC-Light test, which is a single collection test that meets USPSTF's guidelines.

Behavioral: Reference Group (Group 3)

Interventions

High Intensity (Group 1) BEHAVIORAL

The high intensity intervention includes: navigated outreach, with four in-depth education outreach sessions; mailed FIT; education material; and follow-up mailed reminders (Group 1). The navigated outreach includes one-on-one information dissemination about CRC, importance of adhering to CRC screening guidelines, identification and solutions to screening barriers, motivation, self-efficacy and comprehension on how to complete the FIT kit, and gathering (if requested) and return of the completed FIT to the laboratory. The educational material (brochure) is specially developed and culturally tailored for the six Tribes recruited for this study. The FIT kit used is the Polymedco OC FIT-CHECK® OC-Light test, which is a single collection test that meets USPSTF's guidelines.

High Intensity (Group 1)

Medium Intensity (Group 2) BEHAVIORAL

The medium intensity intervention includes: mailed FIT; education material; and follow-up mailed reminders (Group 2). The educational material (brochure) is specially developed and culturally tailored for the six Tribes recruited for this study. The FIT kit used is the Polymedco OC FIT-CHECK® OC-Light test, which is a single collection test that meets USPSTF's guidelines.

Medium Intensity (Group 2)

Reference Group (Group 3) BEHAVIORAL

The reference group (Group 3), per IHS guidelines and current standard of care at participating IHS facilities, receives usual care (ie, screening recommendation and a FIT kit at a clinic visit). The FIT kit used is the Polymedco OC FIT-CHECK® OC-Light test, which is a single collection test that meets USPSTF's guidelines.

Reference Group (Group 3)

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• \- None
• Aim 1--Quantitative Research (Efficacy RCT)
• AIs at average-risk for CRC,
• Not "up to date" with US Preventive Services Task Force (USPSTF) CRC screening guidelines (i.e., no guaiac fecal occult blood test \[FOBT\] or FIT in past year; no flexible sigmoidoscopy in past 5 years; no colonoscopy in past 10 years), and
• Residing in one of the six Pueblo Tribes participating in the research.
• History of CRC, total colectomy, adenomatous polyps, or history of inflammatory bowel disease,
• Up-to-date with CRC screening,
• Severe comorbidity,
• No visit to IHS facilities in the past three years,
• Incarceration,
• Family history of CRC, or
• Hospice/terminal care status.
• C. Aim 2--Qualitative Research (Understanding Behavior Change Context)
• Participants who completed a FIT (Aim 1),
• Participants who did not complete a FIT (Aim 1),

Sponsors & Collaborators

• University of New Mexico: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of New Mexico School of Medicine

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Health Behavior

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; Behavior

Study Officials

• Shiraz I Mishra, MBBS, PhD

  University of New Mexico School of Medicine

  PRINCIPAL INVESTIGATOR

• Kevin English, DrPH

  Albuquerque Area Indian Health Board

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: August 30, 2016
• Study Start: October 1, 2016
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

US (1)