N/A
Completed N=264
Colorectal Cancer Screening Assessment Study
Source: ClinicalTrials.gov NCT04500171 ↗Enrolled (actual)
264
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcomePrimary: Use of FOBT ColoCARE Home Kit — 14; 2; 14; 0 participants
Summary
This study, led by the American Samoa Community Cancer Coalition's INdigenous Samoan Partnership to Initiate Research Excellence (INSPIRE) and the UH Cancer Center's project team including Dr. Cassel, will utilize a community-based and culturally relevant process to assess the uptake of fecal occult blood testing (FOBT) using tailored colorectal cancer patient education materials for those with inadequate health literacy. Our primary outcomes include: 1) process to develop "suitable" and "comprehensible" health promotion materials for populations in English and Samoan with various health literacy levels, 2) commitment to use the FOBT Colocare home kit, and 3) use of a FOBT Colocare home kit.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Use of FOBT ColoCARE Home Kit |
14; 2; 14; 0 | — |
| PRIMARY Increase Uptake of FOBT ColoCARE Home Kit |
48; 84; 23; 67; 10; 6 | — |
| PRIMARY Modified Patient Education Materials |
41; 18; 27; 10; 13; 25 | — |
Eligibility Criteria
Inclusion Criteria
- Resident of America Samoa
- Over age 50
- Have not been diagnosed or treated for colon cancer
- Is not high risk for CRC by having family history or diagnosed with irritable bowel syndrome
- Can read and speak English and Samoan (can provide written informed consent)
- Have a home address and working phone
- Is willing to provide information on their health behaviors
Exclusion Criteria
- persons who indicate they speak or read and write Samoan or English less than well
Data sourced from ClinicalTrials.gov (NCT04500171). 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.