N/A
N=264
Colorectal Cancer Screening Assessment Study
Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04500171 ↗Enrolled (actual)
264
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Use of FOBT ColoCARE Home Kit — 14; 2; 14; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Colocare Instruction Sheet: SAM + CAM SMOG (Behavioral); CDC Colorectal cancer screening for life brochure: SAM + CAM SMOG (Behavioral); Colocare Instruction Sheet: SAM + CAM - Superior rating SMOG - 5th Grade Level (Behavioral); CDC Colorectal Cancer Screening for Life Brochure: SAM + CAM - Superior rating SMOG - 5th Grade Level (Behavioral); Colocare Instruction Video: Modified SAM + CAM -Superior rating (Behavioral); Colocare Instruction Sheet: SAM + CAM Cloze Procedure (Behavioral); CDC Colorectal cancer screening for life brochure: SAM + CAM Cloze Procedure (Behavioral); Colocare Instruction Sheet: SAM + CAM - Superior rating Cloze Procedure (Behavioral); CDC Colorectal Cancer Screening for Life Brochure: SAM + CAM - Superior rating Cloze Procedure (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Hawaii
- Primary completion
- Jun 2023
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 | — |
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.
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.