Clinical trial NCT04500171: Colorectal Cancer Screening Assessment Study
Official title: Colorectal Cancer Screening Assessment Study in American Samoa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: health literacy
screening
Lead sponsor: University of Hawaii
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 262
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Patient Education Materials
timeFrame: 1 Month
measure: Increase uptake of FOBT ColoCARE Home kit
timeFrame: 2 Months
measure: ColoCARE Completion Efficacy
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Pago Pago
country: American Samoa
facility: American Samoa Community Cancer Coalition
city: Tafuna
country: American Samoa
facility: American Samoa Power Authority Abe Malae Operations Center
Study officials:
affiliation: American Samoa Community Cancer Coalition
name: Victor Tofaeono, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: American Samoa Department of Health (2013). Behavioral Risk Factor Surveillance Survey. Results and Data Report. Fagaalu, American Samoa
citation: 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.
citation: 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.
citation: Johnston LG. Introduction to respondent-driven sampling. Technical report. 2008 http://bit.ly/OHgGX5