NCT02882620Completed
Enhancing Prevention Pathways Toward Tribal Colorectal Health
Source: ClinicalTrials.gov · Last updated 25 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 1788 (actual)
- First submitted
- 12 Aug 2016
- Start date
- 1 Oct 2016
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- University of New Mexico
- Diseases
- Colorectal cancer
- NCT number
- NCT02882620
What you commit to
- Study type: Interventional
- Participants enrolled: 1788
- From 1 Oct 2016 to the primary completion date, 30 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of CRC, total colectomy, adenomatous polyps, or history of inflammatory bowel disease,
- Family history of CRC, or
Other
- \- None
- Aim 1--Quantitative Research (Efficacy RCT)
- Up-to-date with CRC screening,
- Severe comorbidity,
- No visit to IHS facilities in the past three years,
- Incarceration,
- Hospice/terminal care status.
- Aim 2--Qualitative Research (Understanding Behavior Change Context)
- \- None
Who the study is looking for
- 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.
- 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.
Criteria the registry did not label
- Aim 1--Qualitative Research (Intervention Finalization)
- Inclusion Criterion:
- \- Adult (45-75 years) AIs.
Age in the registry: 45 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of New Mexico, School of Medicine Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.