<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04500171</url>
  </required_header>
  <id_info>
    <org_study_id>Cassel-2020-1</org_study_id>
    <nct_id>NCT04500171</nct_id>
  </id_info>
  <brief_title>Colorectal Cancer Screening Assessment Study</brief_title>
  <official_title>Colorectal Cancer Screening Assessment Study in American Samoa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Hawaii</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Hawaii</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study, led by the American Samoa Community Cancer Coalition's INdigenous Samoan&#xD;
      Partnership to Initiate Research Excellence (INSPIRE) and the UH Cancer Center's project team&#xD;
      including Dr. Cassel, will utilize a community-based and culturally relevant process to&#xD;
      assess the uptake of fecal occult blood testing (FOBT) using tailored colorectal cancer&#xD;
      patient education materials for those with inadequate health literacy. Our primary outcomes&#xD;
      include: 1) process to develop &quot;suitable&quot; and &quot;comprehensible&quot; health promotion materials for&#xD;
      populations in English and Samoan with various health literacy levels, 2) commitment to use&#xD;
      the FOBT Colocare home kit, and 3) use of a FOBT Colocare home kit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Utilizing the Behavioral Model of Health Services Use as a conceptual framework and the&#xD;
      evidence-based program &quot;Against Colorectal Cancer in Our Neighborhoods&quot; (ACCION) for the&#xD;
      Latino population in Texas as a guide, the proposed study will conduct a randomized&#xD;
      controlled trial of Indigenous Samoan participants (N=312), age≥ 50 recruited using&#xD;
      Respondent-Driven Sampling (RDS). This design will compare use of non-tailored instruction&#xD;
      for completing ColoCare FOBT home-kits (N=156) versus the experimental condition, using a&#xD;
      ColoCare FOBT home-kit with instructions tailored to low health literacy and to enhance&#xD;
      CRC-Knowledge Attitudes and Behavior (KAB) - (N=156). Our goal is to test the influence of&#xD;
      tailored materials on timely completion of CRC screening using the ColoCARE FOBT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 21, 2020</start_date>
  <completion_date type="Anticipated">August 25, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 25, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.&#xD;
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.</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Modified Patient Education Materials</measure>
    <time_frame>1 Month</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Increase uptake of FOBT ColoCARE Home kit</measure>
    <time_frame>2 Months</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ColoCARE Completion Efficacy</measure>
    <time_frame>3 Months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">262</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>English Original Assessment Tools</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Short-Test of Functional Health Literacy in Adults ColoCARE Instruction Sheet CDC Colorectal Cancer Screening for Life Brochure ColoCARE Reply Card</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Samoan Original Assessment Tools</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Samoan Short-Test of Functional Health Literacy in Adults ColoCARE Instruction sheet CDC Colorectal Cancer Screening for Life Brochure ColoCARE Reply Card</description>
  </arm_group>
  <arm_group>
    <arm_group_label>English Modified Assessment Tools</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Short-Test of Functional Health Literacy in Adults Modified ColoCARE Instruction Sheet Modified Colorectal Cancer Screening Brochure ColoCARE Reply Card</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Samoan Modified Assessment Tools</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Samoan Short Test of Functional Health Literacy in Adults Modified ColoCARE Instruction Sheet Modified Colorectal Cancer Screening Brochure ColoCARE Reply Card</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Colocare Instruction Sheet: SAM + CAM SMOG</intervention_name>
    <description>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</description>
    <arm_group_label>English Original Assessment Tools</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CDC Colorectal cancer screening for life brochure: SAM + CAM SMOG</intervention_name>
    <description>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</description>
    <arm_group_label>English Original Assessment Tools</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Colocare Instruction Sheet: SAM + CAM - Superior rating SMOG - 5th Grade Level</intervention_name>
    <description>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</description>
    <arm_group_label>English Modified Assessment Tools</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CDC Colorectal Cancer Screening for Life Brochure: SAM + CAM - Superior rating SMOG - 5th Grade Level</intervention_name>
    <description>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</description>
    <arm_group_label>English Modified Assessment Tools</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Colocare Instruction Video: Modified SAM + CAM -Superior rating</intervention_name>
    <description>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</description>
    <arm_group_label>English Modified Assessment Tools</arm_group_label>
    <arm_group_label>Samoan Modified Assessment Tools</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Colocare Instruction Sheet: SAM + CAM Cloze Procedure</intervention_name>
    <description>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</description>
    <arm_group_label>Samoan Original Assessment Tools</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CDC Colorectal cancer screening for life brochure: SAM + CAM Cloze Procedure</intervention_name>
    <description>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</description>
    <arm_group_label>Samoan Original Assessment Tools</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Colocare Instruction Sheet: SAM + CAM - Superior rating Cloze Procedure</intervention_name>
    <description>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</description>
    <arm_group_label>Samoan Modified Assessment Tools</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CDC Colorectal Cancer Screening for Life Brochure: SAM + CAM - Superior rating Cloze Procedure</intervention_name>
    <description>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</description>
    <arm_group_label>Samoan Modified Assessment Tools</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Resident of America Samoa&#xD;
&#xD;
          2. Over age 50&#xD;
&#xD;
          3. Have not been diagnosed or treated for colon cancer&#xD;
&#xD;
          4. Is not high risk for CRC by having family history or diagnosed with irritable bowel&#xD;
             syndrome&#xD;
&#xD;
          5. Can read and speak English and Samoan (can provide written informed consent)&#xD;
&#xD;
          6. Have a home address and working phone&#xD;
&#xD;
          7. Is willing to provide information on their health behaviors&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  persons who indicate they speak or read and write Samoan or English less than well&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Victor Tofaeono, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>American Samoa Community Cancer Coalition</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>American Samoa Community Cancer Coalition</name>
      <address>
        <city>Pago Pago</city>
        <zip>96799</zip>
        <country>American Samoa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American Samoa Power Authority Abe Malae Operations Center</name>
      <address>
        <city>Tafuna</city>
        <zip>96799</zip>
        <country>American Samoa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>American Samoa</country>
  </location_countries>
  <reference>
    <citation>American Samoa Department of Health (2013). Behavioral Risk Factor Surveillance Survey. Results and Data Report. Fagaalu, American Samoa</citation>
  </reference>
  <reference>
    <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>
    <PMID>21318011</PMID>
  </reference>
  <reference>
    <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>
    <PMID>9463853</PMID>
  </reference>
  <reference>
    <citation>Johnston LG. Introduction to respondent-driven sampling. Technical report. 2008 http://bit.ly/OHgGX5</citation>
  </reference>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>December 11, 2021</last_update_submitted>
  <last_update_submitted_qc>December 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>health literacy</keyword>
  <keyword>screening</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>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.&#xD;
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.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>September 2020</ipd_time_frame>
    <ipd_access_criteria>Data will be accessible only to the study staff to ensure confidentiality. Study staff includes Principal Investigators, Project Director, and Researchers.&#xD;
Upon completion community members and partners such as the Department of Health, Lyndon B. Johnson Tropical Medical Center, and the Cancer Council of the Pacific Islands will have access to aggregated data</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04500171
org study id: Cassel-2020-1
nct id: NCT04500171
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
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
masking: None (Open Label)
measure: Modified Patient Education Materials
time frame: 1 Month
description: 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).
measure: Increase uptake of FOBT ColoCARE Home kit
time frame: 2 Months
description: 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).
measure: ColoCARE Completion Efficacy
time frame: 3 Months
description: 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.
arm group label: English Original Assessment Tools
arm group type: Active Comparator
description: Short-Test of Functional Health Literacy in Adults ColoCARE Instruction Sheet CDC Colorectal Cancer Screening for Life Brochure ColoCARE Reply Card
arm group label: Samoan Original Assessment Tools
arm group type: Active Comparator
description: Samoan Short-Test of Functional Health Literacy in Adults ColoCARE Instruction sheet CDC Colorectal Cancer Screening for Life Brochure ColoCARE Reply Card
arm group label: English Modified Assessment Tools
arm group type: Experimental
description: Short-Test of Functional Health Literacy in Adults Modified ColoCARE Instruction Sheet Modified Colorectal Cancer Screening Brochure ColoCARE Reply Card
arm group label: Samoan Modified Assessment Tools
arm group type: Experimental
description: Samoan Short Test of Functional Health Literacy in Adults Modified ColoCARE Instruction Sheet Modified Colorectal Cancer Screening Brochure ColoCARE Reply Card
intervention type: Behavioral
intervention name: Colocare Instruction Sheet: SAM + CAM SMOG
description: 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
arm group label: English Original Assessment Tools
intervention type: Behavioral
intervention name: CDC Colorectal cancer screening for life brochure: SAM + CAM SMOG
description: 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
arm group label: English Original Assessment Tools
intervention type: Behavioral
intervention name: Colocare Instruction Sheet: SAM + CAM - Superior rating SMOG - 5th Grade Level
description: 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
arm group label: English Modified Assessment Tools
intervention type: Behavioral
intervention name: CDC Colorectal Cancer Screening for Life Brochure: SAM + CAM - Superior rating SMOG - 5th Grade Level
description: 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
arm group label: English Modified Assessment Tools
intervention type: Behavioral
intervention name: Colocare Instruction Video: Modified SAM + CAM -Superior rating
description: 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
arm group label: English Modified Assessment Tools
arm group label: Samoan Modified Assessment Tools
intervention type: Behavioral
intervention name: Colocare Instruction Sheet: SAM + CAM Cloze Procedure
description: 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
arm group label: Samoan Original Assessment Tools
intervention type: Behavioral
intervention name: CDC Colorectal cancer screening for life brochure: SAM + CAM Cloze Procedure
description: 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
arm group label: Samoan Original Assessment Tools
intervention type: Behavioral
intervention name: Colocare Instruction Sheet: SAM + CAM - Superior rating Cloze Procedure
description: 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
arm group label: Samoan Modified Assessment Tools
intervention type: Behavioral
intervention name: CDC Colorectal Cancer Screening for Life Brochure: SAM + CAM - Superior rating Cloze Procedure
description: 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
arm group label: Samoan Modified Assessment Tools
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Victor Tofaeono, M.D.
role: Principal Investigator
affiliation: American Samoa Community Cancer Coalition
facility: 
facility: 
country: American Samoa
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.
PMID: 21318011
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.
PMID: 9463853
citation: Johnston LG. Introduction to respondent-driven sampling. Technical report. 2008 http://bit.ly/OHgGX5
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
sharing ipd: Yes
ipd description: 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.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: September 2020
ipd access criteria: Data will be accessible only to the study staff to ensure confidentiality. Study staff includes Principal Investigators, Project Director, and Researchers.
Upon completion community members and partners such as the Department of Health, Lyndon B. Johnson Tropical Medical Center, and the Cancer Council of the Pacific Islands will have access to aggregated data