Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT02882620
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT02882620
Study Brief:
Protocol Section:
NCT02882620