Colorectal Cancer Screening Assessment Study

Not Applicable

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT04500171
• Lead Sponsor: University of Hawaii

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.

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 Timeline

• Study First Submitted: 2020-07-23
• Study First Submitted QC: 2020-07-31
• Study First Posted: 2020-08-05
• Study Start: 2020-09-21
• Primary Completion: 2023-06-08
• Study Completion: 2023-06-08
• Status Verified: 2024-04
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 262

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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).
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.
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).

Trial Locations

Locations (2)

American Samoa Power Authority Abe Malae Operations Center; 🇦🇸 Tafuna, American Samoa

American Samoa Community Cancer Coalition; 🇦🇸 Pago Pago, American Samoa