Colorectal Cancer Screening Assessment Study

University of Hawaii

Status: Completed

Conditions: Colorectal Cancer

Treatments: Behavioral: Colocare Instruction Video: Modified SAM + CAM -Superior rating; Behavioral: CDC Colorectal Cancer Screening for Life Brochure: SAM + CAM - Superior rating 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 Sheet: SAM + CAM - Superior rating Cloze Procedure; Behavioral: CDC Colorectal cancer screening for life brochure: SAM + CAM SMOG; Behavioral: Colocare Instruction Sheet: SAM + CAM Cloze Procedure; Behavioral: Colocare Instruction Sheet: SAM + CAM SMOG; Behavioral: CDC Colorectal cancer screening for life brochure: SAM + CAM Cloze Procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT04500171

Cassel-2020-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 262 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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262 participants in 4 patient groups

English Original Assessment Tools

Active Comparator group

Description:

Short-Test of Functional Health Literacy in Adults ColoCARE Instruction Sheet CDC Colorectal Cancer Screening for Life Brochure ColoCARE Reply Card

Treatment:

Behavioral: Colocare Instruction Sheet: SAM + CAM SMOG

Behavioral: CDC Colorectal cancer screening for life brochure: SAM + CAM SMOG

Samoan Original Assessment Tools

Active Comparator group

Description:

Samoan Short-Test of Functional Health Literacy in Adults ColoCARE Instruction sheet CDC Colorectal Cancer Screening for Life Brochure ColoCARE Reply Card

Treatment:

Behavioral: CDC Colorectal cancer screening for life brochure: SAM + CAM Cloze Procedure

Behavioral: Colocare Instruction Sheet: SAM + CAM Cloze Procedure

English Modified Assessment Tools

Experimental group

Description:

Short-Test of Functional Health Literacy in Adults Modified ColoCARE Instruction Sheet Modified Colorectal Cancer Screening Brochure ColoCARE Reply Card

Treatment:

Behavioral: CDC Colorectal Cancer Screening for Life Brochure: SAM + CAM - Superior rating SMOG - 5th Grade Level

Behavioral: Colocare Instruction Sheet: SAM + CAM - Superior rating SMOG - 5th Grade Level

Behavioral: Colocare Instruction Video: Modified SAM + CAM -Superior rating

Samoan Modified Assessment Tools

Experimental group

Description:

Samoan Short Test of Functional Health Literacy in Adults Modified ColoCARE Instruction Sheet Modified Colorectal Cancer Screening Brochure ColoCARE Reply Card

Treatment:

Behavioral: Colocare Instruction Sheet: SAM + CAM - Superior rating Cloze Procedure

Behavioral: CDC Colorectal Cancer Screening for Life Brochure: SAM + CAM - Superior rating Cloze Procedure

Behavioral: Colocare Instruction Video: Modified SAM + CAM -Superior rating