Study Results
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View full resultsBasic Information
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COMPLETED
NA
264 participants
INTERVENTIONAL
2020-09-21
2023-06-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
This research project will be the first to test the efficacy of the ColoCare FOBT home kit as a CRC screening intervention using a classical experimental (randomized clinical trial) in American Samoa. Second, the ColoCare kits can be identified as a cost-effective and culturally appropriate alternative to traditional FOBT home test kits. Lastly, results will be used to develop recommendations in healthcare delivery systems to improve information, communication, informed decision-making, and access to care in American Samoa.
SCREENING
NONE
Study Groups
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English Original Assessment Tools
Short-Test of Functional Health Literacy in Adults ColoCARE Instruction Sheet CDC Colorectal Cancer Screening for Life Brochure ColoCARE Reply Card
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
Samoan Original Assessment Tools
Samoan Short-Test of Functional Health Literacy in Adults ColoCARE Instruction sheet CDC Colorectal Cancer Screening for Life Brochure ColoCARE Reply Card
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
English Modified Assessment Tools
Short-Test of Functional Health Literacy in Adults Modified ColoCARE Instruction Sheet Modified Colorectal Cancer Screening Brochure ColoCARE Reply Card
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
Samoan Modified Assessment Tools
Samoan Short Test of Functional Health Literacy in Adults Modified ColoCARE Instruction Sheet Modified Colorectal Cancer Screening Brochure ColoCARE Reply Card
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 - 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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
50 Years
ALL
Yes
Sponsors
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University of Hawaii
OTHER
Responsible Party
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Principal Investigators
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Victor Tofaeono, M.D.
Role: PRINCIPAL_INVESTIGATOR
American Samoa Community Cancer Coalition
Locations
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American Samoa Community Cancer Coalition
Pago Pago, , American Samoa
American Samoa Power Authority Abe Malae Operations Center
Tafuna, , American Samoa
Countries
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References
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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.
Walter SD, Eliasziw M, Donner A. Sample size and optimal designs for reliability studies. Stat Med. 1998 Jan 15;17(1):101-10. doi: 10.1002/(sici)1097-0258(19980115)17:13.0.co;2-e.
Johnston LG. Introduction to respondent-driven sampling. Technical report. 2008 http://bit.ly/OHgGX5
Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Other Identifiers
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Cassel-2020-1
Identifier Type: -
Identifier Source: org_study_id
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