Clinical Trials Directory

Trials / Completed

CompletedNCT04500171

Colorectal Cancer Screening Assessment Study

Colorectal Cancer Screening Assessment Study in American Samoa

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
264 (actual)
Sponsor
University of Hawaii · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Accepted

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.

Detailed description

Utilizing the Behavioral Model of Health Services Use as a conceptual framework and the evidence-based program "Against Colorectal Cancer in Our Neighborhoods" (ACCION) for the Latino population in Texas as a guide, the proposed study will conduct a randomized controlled trial of Indigenous Samoan participants (N=312), age≥ 50 recruited using Respondent-Driven Sampling (RDS). This design will compare use of non-tailored instruction for completing ColoCare FOBT home-kits (N=156) versus the experimental condition, using a ColoCare FOBT home-kit with instructions tailored to low health literacy and to enhance CRC-Knowledge Attitudes and Behavior (KAB) - (N=156). Our goal is to test the influence of tailored materials on timely completion of CRC screening using the ColoCARE FOBT.

Conditions

Interventions

TypeNameDescription
BEHAVIORALColocare Instruction Sheet: SAM + CAM SMOGSuitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
BEHAVIORALCDC Colorectal cancer screening for life brochure: SAM + CAM SMOGSuitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
BEHAVIORALColocare Instruction Sheet: SAM + CAM - Superior rating SMOG - 5th Grade LevelSuitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
BEHAVIORALCDC Colorectal Cancer Screening for Life Brochure: SAM + CAM - Superior rating SMOG - 5th Grade LevelSuitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
BEHAVIORALColocare Instruction Video: Modified SAM + CAM -Superior ratingSuitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
BEHAVIORALColocare Instruction Sheet: SAM + CAM Cloze ProcedureSuitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
BEHAVIORALCDC Colorectal cancer screening for life brochure: SAM + CAM Cloze ProcedureSuitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
BEHAVIORALColocare Instruction Sheet: SAM + CAM - Superior rating Cloze ProcedureSuitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
BEHAVIORALCDC Colorectal Cancer Screening for Life Brochure: SAM + CAM - Superior rating Cloze ProcedureSuitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words

Timeline

Start date
2020-09-21
Primary completion
2023-06-08
Completion
2023-06-08
First posted
2020-08-05
Last updated
2025-06-24
Results posted
2025-06-24

Locations

2 sites across 1 country: American Samoa

Source: ClinicalTrials.gov record NCT04500171. Inclusion in this directory is not an endorsement.