Clinical trial · Interventional
Enhancing Prevention Pathways Toward Tribal Colorectal Health
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasm | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High Intensity (Group 1) | Behavioral | — | UNRESOLVED |
| Medium Intensity (Group 2) | Behavioral | — | UNRESOLVED |
| Reference Group (Group 3) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- High Intensity (Group 1)
- description
- 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.
- interventionNames
- Behavioral: High Intensity (Group 1)
- type
- EXPERIMENTAL
- label
- Medium Intensity (Group 2)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 75 Years
Show eligibility criteria text
A. Aim 1--Qualitative Research (Intervention Finalization) Inclusion Criterion: \- Adult (45-75 years) AIs. Exclusion criteria: \- None Aim 1--Quantitative Research (Efficacy RCT) Inclusion Criteria: * 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. Exclusion Criteria: meeting at least one of the following criteria: * 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) Inclusion Criteria: * Participants who completed a FIT (Aim 1), * Participants who did not complete a FIT (Aim 1), * Navigators participating in the high intensity interventions (Aim 1), * Health care providers and medical directors of the IHS facilities participating in the study. Exclusion Criteria: \- None
References
Publications (0)
Data not yet available