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NCT04500171 Clinical Trial

Colorectal Cancer Screening Assessment Study

Colorectal Cancer Clinical Trial

Official title:
Colorectal Cancer Screening Assessment Study in American Samoa

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04500171
Other study ID # Cassel-2020-1
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 21, 2020
Est. completion date August 25, 2025

Study information
Verified date December 2021
Source University of Hawaii
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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), ageā‰„ 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 262
Est. completion date August 25, 2025
Est. primary completion date December 25, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: 1. Resident of America Samoa 2. Over age 50 3. Have not been diagnosed or treated for colon cancer 4. Is not high risk for CRC by having family history or diagnosed with irritable bowel syndrome 5. Can read and speak English and Samoan (can provide written informed consent) 6. Have a home address and working phone 7. 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Colocare Instruction Sheet: SAM + CAM SMOG
Suitability 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
• CDC Colorectal cancer screening for life brochure: SAM + CAM SMOG
Suitability 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
• Colocare Instruction Sheet: SAM + CAM - Superior rating SMOG - 5th Grade Level
Suitability 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
• CDC Colorectal Cancer Screening for Life Brochure: SAM + CAM - Superior rating SMOG - 5th Grade Level
Suitability 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
• Colocare Instruction Video: Modified SAM + CAM -Superior rating
Suitability 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
• Colocare Instruction Sheet: SAM + CAM Cloze Procedure
Suitability 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
• CDC Colorectal cancer screening for life brochure: SAM + CAM Cloze Procedure
Suitability 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
• Colocare Instruction Sheet: SAM + CAM - Superior rating Cloze Procedure
Suitability 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
• CDC Colorectal Cancer Screening for Life Brochure: SAM + CAM - Superior rating Cloze Procedure
Suitability 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

Locations
Country Name City State
American Samoa American Samoa Community Cancer Coalition Pago Pago
American Samoa American Samoa Power Authority Abe Malae Operations Center Tafuna

Sponsors (1)
Lead Sponsor Collaborator
University of Hawaii

Country where clinical trial is conducted

American Samoa, 

References & Publications (4)

American Samoa Department of Health (2013). Behavioral Risk Factor Surveillance Survey. Results and Data Report. Fagaalu, American Samoa

Efird J. Blocked randomization with randomly selected block sizes. Int J Environ Res Public Health. 2011 Jan;8(1):15-20. doi: 10.3390/ijerph8010015. Epub 2010 Dec 23. — View Citation

Johnston LG. Introduction to respondent-driven sampling. Technical report. 2008 http://bit.ly/OHgGX5

Walter SD, Eliasziw M, Donner A. Sample size and optimal designs for reliability studies. Stat Med. 1998 Jan 15;17(1):101-10. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Modified Patient Education Materials Use a combination of inadequate health literacy recommendations, suitable, and comprehensible assessment methods to develop modified culturally appropriate patient education materials for Colorectal Cancer (CRC). 1 Month
Primary Increase uptake of FOBT ColoCARE Home kit 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). 2 Months
Primary ColoCARE Completion Efficacy Using data gathered from individual results cards (e.g. response, accuracy, etc.) and qualitative data analysis to determine the influence of tailored materials on timely completion of the ColoCARE FOBT home kit. 3 Months
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