Phase 1
Completed N=183
Health Service Intervention for the Improvement of Access and Adherence to Colorectal Cancer Screening
Source: ClinicalTrials.gov NCT04607291 ↗Enrolled (actual)
183
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcomePrimary: Change in Screening Metrics — 42; 8; 37; 13 Participants
Summary
This phase I study investigates how well a health service program called Witness CARES Services works in increasing access and adherence to colorectal cancer screening in patients who have not undergone a colorectal screening in the past year. Providing patients with navigational and screening services via Witness CARES Services may improve access to and adherence levels of colorectal screening.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Screening Metrics |
42; 8; 37; 13; 33; 17 | — |
| PRIMARY Model Development for Prediction of Intent and Colorectal Cancer (CRC) Screening Behaviors |
56; 127 | — |
| SECONDARY Prediction of Which CRC Screening Test is Most Acceptable |
112; 71; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Participants who are non-adherent to CRC screening over the past year (i.e., no stool testing in past 11 months or colonoscopy for over 9 years)
- Medicaid or Medicaid/Medicare subscribers
- Uninsured patients may be included from Mercy Comprehensive Care Center (MCCC), but will only be eligible for services to obtain fecal immunochemical tests (FIT) through the New York State (NYS) Cancer Services Program
Exclusion Criteria
- Any participants from the lists of gaps in care clients from insurance or primary care practices who report having had a colonoscopy in the past 9 years (or having positive findings such as polyps, 5 years) or having completed some type of fecal test for CRC will be excluded
- Participants under 50 will be excluded unless they have been deemed high risk by their physician, and have a prescription for CRC screening
- Participants symptomatic for CRC will be excluded from the study
Data sourced from ClinicalTrials.gov (NCT04607291). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.