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Colorectal CancerNCT04500171

Colorectal Cancer Screening Assessment Study

A study testing Colocare Instruction Sheet: SAM + CAM SMOG, CDC Colorectal cancer screening for life brochure: SAM + CAM SMOG and Colocare Instruction Sheet: SAM + CAM - Superior rating SMOG - 5th Grade Level in people with Colorectal Cancer, run by University of Hawaii at 2 sites in American Samoa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Colorectal Cancer
What is being tested?
Colocare Instruction Sheet: SAM + CAM SMOG, CDC Colorectal cancer screening for life brochure: SAM + CAM SMOG and Colocare Instruction Sheet: SAM + CAM - Superior rating SMOG - 5th Grade Level
Could I receive a placebo?
No, everyone receives an active treatment
How many people
264 participants
Where
2 sitesAmerican Samoa
Study dates
21 Sep 2020to 8 Jun 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

American Samoa2 sites

  • American Samoa Community Cancer Coalition

    Pago Pago, 96799

  • American Samoa Power Authority Abe Malae Operations Center

    Tafuna, 96799

About this study

Official title: Colorectal Cancer Screening Assessment Study in American Samoa

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.

Read the 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.

Being tested
Colocare Instruction Sheet: SAM + CAM SMOG, CDC Colorectal cancer screening for life brochure: SAM + CAM SMOG, Colocare Instruction Sheet: SAM + CAM - Superior rating SMOG - 5th Grade Level, CDC Colorectal Cancer Screening for Life Brochure: SAM + CAM - Superior rating SMOG - 5th Grade Level, Colocare Instruction Video: Modified SAM + CAM -Superior rating
Keywords
health literacy, screening
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Colocare Instruction Sheet: SAM + CAM SMOGBehavioural

    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 SMOGBehavioural

    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 LevelBehavioural

    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 LevelBehavioural

    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 ratingBehavioural

    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 ProcedureBehavioural

    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 ProcedureBehavioural

    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 ProcedureBehavioural

    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 ProcedureBehavioural

    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

Study groups in NCT04500171
Study groupRoleWhat they receive
English Original Assessment ToolsActive comparatorShort-Test of Functional Health Literacy in Adults ColoCARE Instruction Sheet CDC Colorectal Cancer Screening for Life Brochure ColoCARE Reply Card
Receives: Behavioral: Colocare Instruction Sheet: SAM + CAM SMOG; Behavioral: CDC Colorectal cancer screening for life brochure: SAM + CAM SMOG
Samoan Original Assessment ToolsActive comparatorSamoan Short-Test of Functional Health Literacy in Adults ColoCARE Instruction sheet CDC Colorectal Cancer Screening for Life Brochure ColoCARE Reply Card
Receives: Behavioral: Colocare Instruction Sheet: SAM + CAM Cloze Procedure; Behavioral: CDC Colorectal cancer screening for life brochure: SAM + CAM Cloze Procedure
English Modified Assessment ToolsExperimentalShort-Test of Functional Health Literacy in Adults Modified ColoCARE Instruction Sheet Modified Colorectal Cancer Screening Brochure ColoCARE Reply Card
Receives: 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
Samoan Modified Assessment ToolsExperimentalSamoan Short Test of Functional Health Literacy in Adults Modified ColoCARE Instruction Sheet Modified Colorectal Cancer Screening Brochure ColoCARE Reply Card
Receives: Behavioral: Colocare Instruction Video: Modified SAM + CAM -Superior rating; Behavioral: Colocare Instruction Sheet: SAM + CAM - Superior rating Cloze Procedure; Behavioral: CDC Colorectal Cancer Screening for Life Brochure: SAM + CAM - Superior rating Cloze Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Use of FOBT ColoCARE Home Kit

    Number of participants reporting results for the FOBT ColoCARE Home kit

    Measured: 3 months

  2. Increase Uptake of FOBT ColoCARE Home Kit

    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.

    Measured: 2 months

  3. Modified Patient Education Materials

    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".

    Measured: 1 Month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2020
  2. Study start21 Sep 2020
  3. Primary completion8 Jun 2023
  4. Study completion8 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
264 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04500171
Sponsor's protocol ID
Cassel-2020-1
Status last verified
Jun 2025
First submitted
23 Jul 2020
Last updated
24 Jun 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study data will be administered in accordance with UHCC policies. Data will be accessible only to study staff. Study staff includes Principal Investigators, Project Director, and Researchers. Upon completion community members and partners will have access to aggregated data. After data analysis is completed, study materials will be kept in the PI's locked office and destroyed after five years. The data and associated documentation will be available to the study team only under a data-sharing agreement that provides for: a commitment to using the data only for research purposes and not to identify any individual participant, a commitment to securing the data using appropriate computer technology, and a commitment to destroying the data after analyses are completed. The products/resources that result of this study will be disseminated via publications, presentations at national conferences, presentations, and reports to study stakeholders.

Publications

  • American Samoa Department of Health (2013). Behavioral Risk Factor Surveillance Survey. Results and Data Report. Fagaalu, American Samoa

  • 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.

    PubMed 21318011

  • 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.

    PubMed 9463853

  • Johnston LG. Introduction to respondent-driven sampling. Technical report. 2008 http://bit.ly/OHgGX5

Questions about this trial

What is this clinical trial studying?

A study testing Colocare Instruction Sheet: SAM + CAM SMOG, CDC Colorectal cancer screening for life brochure: SAM + CAM SMOG and Colocare Instruction Sheet: SAM + CAM - Superior rating SMOG - 5th Grade Level in people with Colorectal Cancer, run by University of Hawaii at 2 sites in American Samoa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in American Samoa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Use of FOBT ColoCARE Home Kit (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04500171, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.

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Colorectal Cancer Screening Assessment Study | AzTrials