Colorectal Cancer Screening Assessment Study

Sponsor

University of Hawaii (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04500171

Collaborator

(none)

262

Enrollment

Locations

Arms

59.1

Anticipated Duration (Months)

131

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Behavioral: Colocare Instruction Sheet: SAM + CAM SMOG Behavioral: CDC Colorectal cancer screening for life brochure: SAM + CAM SMOG 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 Cloze Procedure Behavioral: CDC Colorectal cancer screening for life brochure: SAM + CAM Cloze Procedure Behavioral: Colocare Instruction Sheet: SAM + CAM - Superior rating Cloze Procedure Behavioral: CDC Colorectal Cancer Screening for Life Brochure: SAM + CAM - Superior rating Cloze Procedure	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

262 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The health belief model and social cognitive theory were used as foundational principles to develop an intervention that builds awareness to initiate a CRC screening behavior modification. 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.The health belief model and social cognitive theory were used as foundational principles to develop an intervention that builds awareness to initiate a CRC screening behavior modification. 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.

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Colorectal Cancer Screening Assessment Study in American Samoa

Actual Study Start Date :

Sep 21, 2020

Anticipated Primary Completion Date :

Dec 25, 2023

Anticipated Study Completion Date :

Aug 25, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Modified Patient Education Materials [1 Month]
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).
Increase uptake of FOBT ColoCARE Home kit [2 Months]
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).
ColoCARE Completion Efficacy [3 Months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

persons who indicate they speak or read and write Samoan or English less than well

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	American Samoa Community Cancer Coalition	Pago Pago		American Samoa	96799
2	American Samoa Power Authority Abe Malae Operations Center	Tafuna		American Samoa	96799

Sponsors and Collaborators

University of Hawaii

Investigators

Principal Investigator: Victor Tofaeono, M.D., American Samoa Community Cancer Coalition

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

University of Hawaii

ClinicalTrials.gov Identifier:

NCT04500171

Other Study ID Numbers:

Cassel-2020-1

First Posted:

Aug 5, 2020

Last Update Posted:

Jan 3, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Hawaii

health literacy

screening

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of Jan 3, 2022