Skip to main content
OpenTrials
Completed

NCT Number: NCT04500171

Colorectal Cancer Screening Assessment Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

American Samoa Community Cancer Coalition, Pago Pago, American Samoa

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colocare Instruction Sheet: SAM + CAM SMOG

Behavioral

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

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

Behavioral

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

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

Behavioral

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

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

Behavioral

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

Colocare Instruction Video: Modified SAM + CAM -Superior rating

Behavioral

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

Colocare Instruction Sheet: SAM + CAM Cloze Procedure

Behavioral

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

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

Behavioral

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

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

Behavioral

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

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

Behavioral

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

Primary outcomes

  1. Use of FOBT ColoCARE Home Kit

    Time frame: 3 months

    Number of participants reporting results for the FOBT ColoCARE Home kit

  2. Increase Uptake of FOBT ColoCARE Home Kit

    Time frame: 2 months

    Change in CRC-Knowledge Attitudes and Behavior (KAB) among subjects who viewed the tailored ColoCARE video. This measure is a 7 question assessment given before and after participants viewed the ColoCARE video. Participants were scored based on their pre and post assessment responses.

  3. Modified Patient Education Materials

    Time frame: 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). Each of the 22 items within the 6 identified categories are given a score of 0 - 2 based upon certain criteria. Total scores are calculated into percentages and 100% to 70% is "adequate", "69% to 40%" is "marginal, while 39% - 0% is "inadequate".

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Registry information

Official study title

Colorectal Cancer Screening Assessment Study in American Samoa

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 5, 2020
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.