Colorectal Cancer Screening Assessment Study
1 other identifier
interventional
264
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable colorectal-cancer
Started Sep 2020
Typical duration for not_applicable colorectal-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2020
CompletedFirst Posted
Study publicly available on registry
August 5, 2020
CompletedStudy Start
First participant enrolled
September 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 8, 2023
CompletedResults Posted
Study results publicly available
June 24, 2025
CompletedJune 24, 2025
June 1, 2025
2.7 years
July 23, 2020
April 7, 2025
June 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Use of FOBT ColoCARE Home Kit
Number of participants reporting results for the FOBT ColoCARE Home kit
3 months
Increase Uptake of FOBT ColoCARE Home Kit
Change in CRC-Knowledge Attitudes and Behavior (KAB) among subjects who viewed the tailored ColoCARE video. This measure is a 7 question assessment given before and after participants viewed the ColoCARE video. Participants were scored based on their pre and post assessment responses.
2 months
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). Each of the 22 items within the 6 identified categories are given a score of 0 - 2 based upon certain criteria. Total scores are calculated into percentages and 100% to 70% is "adequate", "69% to 40%" is "marginal, while 39% - 0% is "inadequate".
1 Month
Study Arms (4)
English Original Assessment Tools
ACTIVE COMPARATORShort-Test of Functional Health Literacy in Adults ColoCARE Instruction Sheet CDC Colorectal Cancer Screening for Life Brochure ColoCARE Reply Card
Samoan Original Assessment Tools
ACTIVE COMPARATORSamoan Short-Test of Functional Health Literacy in Adults ColoCARE Instruction sheet CDC Colorectal Cancer Screening for Life Brochure ColoCARE Reply Card
English Modified Assessment Tools
EXPERIMENTALShort-Test of Functional Health Literacy in Adults Modified ColoCARE Instruction Sheet Modified Colorectal Cancer Screening Brochure ColoCARE Reply Card
Samoan Modified Assessment Tools
EXPERIMENTALSamoan Short Test of Functional Health Literacy in Adults Modified ColoCARE Instruction Sheet Modified Colorectal Cancer Screening Brochure ColoCARE Reply Card
Interventions
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
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
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
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
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
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
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
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
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
You may qualify if:
- 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
You may not qualify if:
- persons who indicate they speak or read and write Samoan or English less than well
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
American Samoa Community Cancer Coalition
Pago Pago, 96799, American Samoa
American Samoa Power Authority Abe Malae Operations Center
Tafuna, 96799, American Samoa
Related Publications (4)
American Samoa Department of Health (2013). Behavioral Risk Factor Surveillance Survey. Results and Data Report. Fagaalu, American Samoa
BACKGROUNDEfird 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.
PMID: 21318011BACKGROUNDWalter 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.
PMID: 9463853BACKGROUNDJohnston LG. Introduction to respondent-driven sampling. Technical report. 2008 http://bit.ly/OHgGX5
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Va'atausili Tofaeono
- Organization
- American Samoa Community Cancer Coalition
Study Officials
- PRINCIPAL INVESTIGATOR
Victor Tofaeono, M.D.
American Samoa Community Cancer Coalition
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2020
First Posted
August 5, 2020
Study Start
September 21, 2020
Primary Completion
June 8, 2023
Study Completion
June 8, 2023
Last Updated
June 24, 2025
Results First Posted
June 24, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- September 2020
- Access Criteria
- Data will be accessible only to the study staff to ensure confidentiality. Study staff includes Principal Investigators, Project Director, and Researchers. Upon completion community members and partners such as the Department of Health, Lyndon B. Johnson Tropical Medical Center, and the Cancer Council of the Pacific Islands will have access to aggregated data
Study data will be administered in accordance with UHCC policies. Data will be accessible only to study staff. Study staff includes Principal Investigators, Project Director, and Researchers. Upon completion community members and partners will have access to aggregated data. After data analysis is completed, study materials will be kept in the PI's locked office and destroyed after five years. The data and associated documentation will be available to the study team only under a data-sharing agreement that provides for: a commitment to using the data only for research purposes and not to identify any individual participant, a commitment to securing the data using appropriate computer technology, and a commitment to destroying the data after analyses are completed. The products/resources that result of this study will be disseminated via publications, presentations at national conferences, presentations, and reports to study stakeholders.