Colorectal Cancer Screening Assessment Study

Colorectal Cancer Screening Assessment Study in American Samoa

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Colocare Instruction Sheet: SAM + CAM SMOG; Behavioral: CDC Colorectal cancer screening for life brochure: SAM + CAM SMOG; 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 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 - Superior rating Cloze Procedure; Behavioral: CDC Colorectal Cancer Screening for Life Brochure: SAM + CAM - Superior rating Cloze Procedure

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.

• Study Type: Interventional
• Enrollment (Actual): 262
• Phase: Not Applicable

Contacts and Locations

Study Locations

• American Samoa
  • Pago Pago, American Samoa, 96799
    • American Samoa Community Cancer Coalition
  • Tafuna, American Samoa, 96799
    • American Samoa Power Authority Abe Malae Operations Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	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; Behavioral: 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
Active Comparator: 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	Behavioral: 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; Behavioral: 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
Experimental: English Modified Assessment Tools; Short-Test of Functional Health Literacy in Adults Modified ColoCARE Instruction Sheet Modified Colorectal Cancer Screening Brochure ColoCARE Reply Card	Behavioral: 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; Behavioral: 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; Behavioral: 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
Experimental: 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	Behavioral: 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; Behavioral: 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; Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Hawaii
• Investigators: Principal Investigator: Victor Tofaeono, M.D., American Samoa Community Cancer Coalition

Publications and helpful links

General Publications

• 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

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2020
• Primary Completion (Anticipated): December 25, 2023
• Study Completion (Anticipated): August 25, 2025

Study Registration Dates

• First Submitted: July 23, 2020
• First Submitted That Met QC Criteria: July 31, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Actual): January 3, 2022
• Last Update Submitted That Met QC Criteria: December 11, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: health literacy; screening
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: Cassel-2020-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

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.

• IPD Sharing Time Frame: September 2020

IPD Sharing 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

• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No