<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/NCT03819920</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-32815</org_study_id>
    <nct_id>NCT03819920</nct_id>
  </id_info>
  <brief_title>Does Knowing One's Estimated Colorectal Cancer Risk Influence Screening Behavior?</brief_title>
  <official_title>Does Knowing One's Estimated Colorectal Cancer Risk Influence Screening Behavior?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</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 is designed to examine the impact of telephone-based colorectal cancer risk&#xD;
      assessment on colorectal screening attitudes and behavior among previously unscreened adults&#xD;
      ages 50 to 75.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Colorectal cancer (CRC) remains the 3rd most common cancer in the US. Most CRCs are&#xD;
      preventable, but screening participation remains suboptimal. Several factors have been&#xD;
      associated with screening compliance, such as perception of CRC risk. Here we study the&#xD;
      impact of telephone-based administration of the National Cancer Institute Colorectal Cancer&#xD;
      Risk Assessment Tool (CCRAT) compared to usual care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 6, 2015</start_date>
  <completion_date type="Actual">January 4, 2019</completion_date>
  <primary_completion_date type="Actual">January 4, 2019</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>Usual care of generalized colorectal cancer screening education over telephone versus personalized risk assessment over telephone using National Cancer Institute Colorectal Cancer Risk Assessment Tool (CCRAT)</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Screening Behavior: Differences in colorectal cancer screening completion rates between usual care (UC) and CCRAT</measure>
    <time_frame>12 months after intervention</time_frame>
    <description>Any CRC screening test completed including stool tests (FOBT (fecal occult blood test), FIT (immunochemical test for fecal blood), stool DNA test), colonoscopy, flexible sigmoidoscopy, double contrast barium enema, CT colonography (virtual colonoscopy)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Screening Behavior: Differences in colorectal cancer screening completion rates between usual care (UC) and CCRAT</measure>
    <time_frame>6 months after intervention</time_frame>
    <description>Any CRC screening test completed including stool tests (FOBT (fecal occult blood test), FIT (immunochemical test for fecal blood), stool DNA test), colonoscopy, flexible sigmoidoscopy, double contrast barium enema, CT colonography (virtual colonoscopy)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in intention to screen at 6 months and 12 months</measure>
    <time_frame>Immediate after intervention, 6 months and 1 year after intervention</time_frame>
    <description>Differences in progressive behavioral stages of adoption from precontemplation to contemplation to preparation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Colorectal cancer screening rates at 12 months as a function of CCRAT score</measure>
    <time_frame>12 months after intervention</time_frame>
    <description>Screening completion at 12 months will be compared between the 3 tertiles of CCRAT score in the intervention group to determine whether there is any relationship between absolute CCRAT score and screening completion</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Risk perception: Health Belief Model Likert Scale</measure>
    <time_frame>Immediate after intervention</time_frame>
    <description>Differences in perception of one's own risk of colorectal cancer ranging from &quot;very unlikely&quot; (minimum) to &quot;very likely&quot; (maximum), with &quot;very unlikely&quot; representing the most favorable outcome of perceived risk and &quot;very likely&quot; representing the most unfavorable outcome of perceived risk.</description>
  </other_outcome>
  <other_outcome>
    <measure>Fear: Health Belief Model Likert Scale</measure>
    <time_frame>Immediate after intervention</time_frame>
    <description>Presence of fear of discovering colorectal cancer on performing screening test ranging from &quot;strongly disagree&quot; (minimum) to &quot;strongly agree&quot; (maximum), with &quot;strongly disagree&quot; representing the most favorable outcome of fear and &quot;strongly agree&quot; representing the most unfavorable outcome of fear.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">229</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Usual Care (UC)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients receive standardized general information about colorectal cancer screening over the telephone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Risk Assessment (CCRAT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient receive personalized colorectal cancer risk assessment over the telephone by answering the questions as outlined in the National Cancer Institute Colorectal Cancer Risk Assessment Tool (https://ccrisktool.cancer.gov/calculator.html)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Risk Assessment (CCRAT)</intervention_name>
    <description>Patient receive personalized colorectal cancer risk assessment over the telephone by answering the questions as outlined in the National Cancer Institute Colorectal Cancer Risk Assessment Tool (https://ccrisktool.cancer.gov/calculator.html)</description>
    <arm_group_label>Risk Assessment (CCRAT)</arm_group_label>
    <other_name>CCRAT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Care (UC)</intervention_name>
    <description>Patients receive standardized general information about colorectal cancer screening over the telephone.</description>
    <arm_group_label>Risk Assessment (CCRAT)</arm_group_label>
    <arm_group_label>Usual Care (UC)</arm_group_label>
    <other_name>UC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient of any participating physician&#xD;
&#xD;
          -  Not having had any colorectal cancer screening test prior&#xD;
&#xD;
          -  Able to speak English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Personal history of inflammatory bowel disease&#xD;
&#xD;
          -  Personal history of colorectal cancer&#xD;
&#xD;
          -  Personal history of Lynch syndrome or Familial Adenomatous Polyposis&#xD;
&#xD;
          -  Have already received colorectal cancer screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Uri Ladabaum, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University School of Medicine</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://ccrisktool.cancer.gov/</url>
    <description>National Cancer Institute Colorectal Cancer Risk Assessment Tool (CCRAT)</description>
  </link>
  <reference>
    <citation>Volk RJ, Linder SK, Lopez-Olivo MA, Kamath GR, Reuland DS, Saraykar SS, Leal VB, Pignone MP. Patient Decision Aids for Colorectal Cancer Screening: A Systematic Review and Meta-analysis. Am J Prev Med. 2016 Nov;51(5):779-791. doi: 10.1016/j.amepre.2016.06.022. Epub 2016 Sep 2.</citation>
    <PMID>27593418</PMID>
  </reference>
  <reference>
    <citation>Champion VL, Christy SM, Rakowski W, Gathirua-Mwangi WG, Tarver WL, Carter-Harris L, Cohee AA, Marley AR, Jessup NM, Biederman E, Kettler CD, Stump TE, Monahan P, Lairson DR, Rawl SM. A Randomized Trial to Compare a Tailored Web-Based Intervention and Tailored Phone Counseling to Usual Care for Increasing Colorectal Cancer Screening. Cancer Epidemiol Biomarkers Prev. 2018 Dec;27(12):1433-1441. doi: 10.1158/1055-9965.EPI-18-0180. Epub 2018 Sep 4.</citation>
    <PMID>30181203</PMID>
  </reference>
  <reference>
    <citation>Miller DP Jr, Denizard-Thompson N, Weaver KE, Case LD, Troyer JL, Spangler JG, Lawler D, Pignone MP. Effect of a Digital Health Intervention on Receipt of Colorectal Cancer Screening in Vulnerable Patients: A Randomized Controlled Trial. Ann Intern Med. 2018 Apr 17;168(8):550-557. doi: 10.7326/M17-2315. Epub 2018 Mar 13.</citation>
    <PMID>29532054</PMID>
  </reference>
  <reference>
    <citation>Christy SM, Rawl SM. Shared decision-making about colorectal cancer screening: a conceptual framework to guide research. Patient Educ Couns. 2013 Jun;91(3):310-7. doi: 10.1016/j.pec.2013.01.015. Epub 2013 Feb 15.</citation>
    <PMID>23419327</PMID>
  </reference>
  <reference>
    <citation>Schroy PC 3rd, Duhovic E, Chen CA, Heeren TC, Lopez W, Apodaca DL, Wong JB. Risk Stratification and Shared Decision Making for Colorectal Cancer Screening: A Randomized Controlled Trial. Med Decis Making. 2016 May;36(4):526-35. doi: 10.1177/0272989X15625622. Epub 2016 Jan 19.</citation>
    <PMID>26785715</PMID>
  </reference>
  <reference>
    <citation>Han PK, Duarte CW, Daggett S, Siewers A, Killam B, Smith KA, Freedman AN. Effects of personalized colorectal cancer risk information on laypersons' interest in colorectal cancer screening: The importance of individual differences. Patient Educ Couns. 2015 Oct;98(10):1280-6. doi: 10.1016/j.pec.2015.07.010. Epub 2015 Jul 19.</citation>
    <PMID>26227576</PMID>
  </reference>
  <reference>
    <citation>Vernon SW, Bartholomew LK, McQueen A, Bettencourt JL, Greisinger A, Coan SP, Lairson D, Chan W, Hawley ST, Myers RE. A randomized controlled trial of a tailored interactive computer-delivered intervention to promote colorectal cancer screening: sometimes more is just the same. Ann Behav Med. 2011 Jun;41(3):284-99. doi: 10.1007/s12160-010-9258-5.</citation>
    <PMID>21271365</PMID>
  </reference>
  <reference>
    <citation>Menon U, Belue R, Wahab S, Rugen K, Kinney AY, Maramaldi P, Wujcik D, Szalacha LA. A randomized trial comparing the effect of two phone-based interventions on colorectal cancer screening adherence. Ann Behav Med. 2011 Dec;42(3):294-303. doi: 10.1007/s12160-011-9291-z.</citation>
    <PMID>21826576</PMID>
  </reference>
  <reference>
    <citation>American Cancer Society. Cancer Facts and Figures 2014. Atlanta, GA: American Cancer Society; 2014.</citation>
  </reference>
  <reference>
    <citation>American Cancer Society. Colorectal Cancer Facts and Figures, 2014-2016. Atlanta, GA: American Cancer Society; 2014.</citation>
  </reference>
  <reference>
    <citation>Howlader N, Noone AM, Krapcho M, et al. SEER Cancer Statistics Review, 1975-2010. Bethesda, MD: National Cancer Institute, 2013.</citation>
  </reference>
  <reference>
    <citation>Edwards BK, Ward E, Kohler BA, Eheman C, Zauber AG, Anderson RN, Jemal A, Schymura MJ, Lansdorp-Vogelaar I, Seeff LC, van Ballegooijen M, Goede SL, Ries LA. Annual report to the nation on the status of cancer, 1975-2006, featuring colorectal cancer trends and impact of interventions (risk factors, screening, and treatment) to reduce future rates. Cancer. 2010 Feb 1;116(3):544-73. doi: 10.1002/cncr.24760.</citation>
    <PMID>19998273</PMID>
  </reference>
  <reference>
    <citation>Shapiro JA, Klabunde CN, Thompson TD, Nadel MR, Seeff LC, White A. Patterns of colorectal cancer test use, including CT colonography, in the 2010 National Health Interview Survey. Cancer Epidemiol Biomarkers Prev. 2012 Jun;21(6):895-904. doi: 10.1158/1055-9965.EPI-12-0192. Epub 2012 Apr 6.</citation>
    <PMID>22490320</PMID>
  </reference>
  <reference>
    <citation>Gimeno Garcia AZ, Hernandez Alvarez Buylla N, Nicolas-Perez D, Quintero E. Public awareness of colorectal cancer screening: knowledge, attitudes, and interventions for increasing screening uptake. ISRN Oncol. 2014 Mar 5;2014:425787. doi: 10.1155/2014/425787. eCollection 2014.</citation>
    <PMID>24729896</PMID>
  </reference>
  <reference>
    <citation>Gimeno Garcia AZ. Factors influencing colorectal cancer screening participation. Gastroenterol Res Pract. 2012;2012:483417. doi: 10.1155/2012/483417. Epub 2011 Dec 1.</citation>
    <PMID>22190913</PMID>
  </reference>
  <reference>
    <citation>Jepson R, Clegg A, Forbes C, Lewis R, Sowden A, Kleijnen J. The determinants of screening uptake and interventions for increasing uptake: a systematic review. Health Technol Assess. 2000;4(14):i-vii, 1-133. No abstract available.</citation>
    <PMID>10984843</PMID>
  </reference>
  <reference>
    <citation>Peterson NB, Dwyer KA, Mulvaney SA, Dietrich MS, Rothman RL. The influence of health literacy on colorectal cancer screening knowledge, beliefs and behavior. J Natl Med Assoc. 2007 Oct;99(10):1105-12.</citation>
    <PMID>17987913</PMID>
  </reference>
  <reference>
    <citation>McCaffery K, Wardle J, Waller J. Knowledge, attitudes, and behavioral intentions in relation to the early detection of colorectal cancer in the United Kingdom. Prev Med. 2003 May;36(5):525-35. doi: 10.1016/s0091-7435(03)00016-1.</citation>
    <PMID>12689797</PMID>
  </reference>
  <reference>
    <citation>Wardle J, Sutton S, Williamson S, Taylor T, McCaffery K, Cuzick J, Hart A, Atkin W. Psychosocial influences on older adults' interest in participating in bowel cancer screening. Prev Med. 2000 Oct;31(4):323-34. doi: 10.1006/pmed.2000.0725.</citation>
    <PMID>11006057</PMID>
  </reference>
  <reference>
    <citation>Robb KA, Miles A, Wardle J. Demographic and psychosocial factors associated with perceived risk for colorectal cancer. Cancer Epidemiol Biomarkers Prev. 2004 Mar;13(3):366-72.</citation>
    <PMID>15006910</PMID>
  </reference>
  <reference>
    <citation>Robb KA, Miles A, Wardle J. Perceived risk of colorectal cancer: sources of risk judgments. Cancer Epidemiol Biomarkers Prev. 2007 Apr;16(4):694-702. doi: 10.1158/1055-9965.EPI-06-0151.</citation>
    <PMID>17416759</PMID>
  </reference>
  <reference>
    <citation>Bae N, Park S, Lim S. Factors associated with adherence to fecal occult blood testing for colorectal cancer screening among adults in the Republic of Korea. Eur J Oncol Nurs. 2014 Feb;18(1):72-7. doi: 10.1016/j.ejon.2013.09.001. Epub 2013 Oct 31.</citation>
    <PMID>24183583</PMID>
  </reference>
  <reference>
    <citation>Hodge F, Maliski S, Itty T, Martinez F. Colorectal cancer screening: the role of perceived susceptibility, risk and cultural illness beliefs among American Indians. J Cult Divers. 2014 Summer;21(2):48-55.</citation>
    <PMID>25011207</PMID>
  </reference>
  <reference>
    <citation>Trauth JM, Ling BS, Weissfeld JL, Schoen RE, Hayran M. Using the transtheoretical model to stage screening behavior for colorectal cancer. Health Educ Behav. 2003 Jun;30(3):322-36. doi: 10.1177/1090198103030003007.</citation>
    <PMID>19731499</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>February 1, 2019</last_update_submitted>
  <last_update_submitted_qc>February 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Uri Ladabaum</investigator_full_name>
    <investigator_title>Professor of Medicine, Director GI Cancer Prevention Program</investigator_title>
  </responsible_party>
  <keyword>cancer screening beliefs</keyword>
  <keyword>colorectal cancer 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>De-identified IPD will be made available to other researchers through a HIPAA compliant data storage system (Stanford Medicine Box) that is password protected</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>2/1/2019-2/1/2021</ipd_time_frame>
    <ipd_access_criteria>Research staff solely associated with the study and/or Graduate or Post-Doc students-who are writing related manuscripts - who have been given permission by the Principal Investigator, Uri Ladabaum can submit a request.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 21, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT03819920/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 1, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT03819920/Prot_SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03819920
org study id: IRB-32815
nct id: NCT03819920
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is designed to examine the impact of telephone-based colorectal cancer risk
      assessment on colorectal screening attitudes and behavior among previously unscreened adults
      ages 50 to 75.
Colorectal cancer (CRC) remains the 3rd most common cancer in the US. Most CRCs are
      preventable, but screening participation remains suboptimal. Several factors have been
      associated with screening compliance, such as perception of CRC risk. Here we study the
      impact of telephone-based administration of the National Cancer Institute Colorectal Cancer
      Risk Assessment Tool (CCRAT) compared to usual care.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Usual care of generalized colorectal cancer screening education over telephone versus personalized risk assessment over telephone using National Cancer Institute Colorectal Cancer Risk Assessment Tool (CCRAT)
primary purpose: Prevention
masking: None (Open Label)
measure: Screening Behavior: Differences in colorectal cancer screening completion rates between usual care (UC) and CCRAT
time frame: 12 months after intervention
description: Any CRC screening test completed including stool tests (FOBT (fecal occult blood test), FIT (immunochemical test for fecal blood), stool DNA test), colonoscopy, flexible sigmoidoscopy, double contrast barium enema, CT colonography (virtual colonoscopy)
measure: Screening Behavior: Differences in colorectal cancer screening completion rates between usual care (UC) and CCRAT
time frame: 6 months after intervention
description: Any CRC screening test completed including stool tests (FOBT (fecal occult blood test), FIT (immunochemical test for fecal blood), stool DNA test), colonoscopy, flexible sigmoidoscopy, double contrast barium enema, CT colonography (virtual colonoscopy)
measure: Change in intention to screen at 6 months and 12 months
time frame: Immediate after intervention, 6 months and 1 year after intervention
description: Differences in progressive behavioral stages of adoption from precontemplation to contemplation to preparation.
measure: Colorectal cancer screening rates at 12 months as a function of CCRAT score
time frame: 12 months after intervention
description: Screening completion at 12 months will be compared between the 3 tertiles of CCRAT score in the intervention group to determine whether there is any relationship between absolute CCRAT score and screening completion
measure: Risk perception: Health Belief Model Likert Scale
time frame: Immediate after intervention
description: Differences in perception of one's own risk of colorectal cancer ranging from "very unlikely" (minimum) to "very likely" (maximum), with "very unlikely" representing the most favorable outcome of perceived risk and "very likely" representing the most unfavorable outcome of perceived risk.
measure: Fear: Health Belief Model Likert Scale
time frame: Immediate after intervention
description: Presence of fear of discovering colorectal cancer on performing screening test ranging from "strongly disagree" (minimum) to "strongly agree" (maximum), with "strongly disagree" representing the most favorable outcome of fear and "strongly agree" representing the most unfavorable outcome of fear.
arm group label: Usual Care (UC)
arm group type: Placebo Comparator
description: Patients receive standardized general information about colorectal cancer screening over the telephone.
arm group label: Risk Assessment (CCRAT)
arm group type: Active Comparator
description: Patient receive personalized colorectal cancer risk assessment over the telephone by answering the questions as outlined in the National Cancer Institute Colorectal Cancer Risk Assessment Tool (https://ccrisktool.cancer.gov/calculator.html)
intervention type: Behavioral
intervention name: Risk Assessment (CCRAT)
description: Patient receive personalized colorectal cancer risk assessment over the telephone by answering the questions as outlined in the National Cancer Institute Colorectal Cancer Risk Assessment Tool (https://ccrisktool.cancer.gov/calculator.html)
arm group label: Risk Assessment (CCRAT)
other name: CCRAT
intervention type: Behavioral
intervention name: Usual Care (UC)
description: Patients receive standardized general information about colorectal cancer screening over the telephone.
arm group label: Risk Assessment (CCRAT)
arm group label: Usual Care (UC)
other name: UC
criteria: 
gender: All
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Uri Ladabaum, MD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
url: https://ccrisktool.cancer.gov/
description: National Cancer Institute Colorectal Cancer Risk Assessment Tool (CCRAT)
citation: Volk RJ, Linder SK, Lopez-Olivo MA, Kamath GR, Reuland DS, Saraykar SS, Leal VB, Pignone MP. Patient Decision Aids for Colorectal Cancer Screening: A Systematic Review and Meta-analysis. Am J Prev Med. 2016 Nov;51(5):779-791. doi: 10.1016/j.amepre.2016.06.022. Epub 2016 Sep 2.
PMID: 27593418
citation: Champion VL, Christy SM, Rakowski W, Gathirua-Mwangi WG, Tarver WL, Carter-Harris L, Cohee AA, Marley AR, Jessup NM, Biederman E, Kettler CD, Stump TE, Monahan P, Lairson DR, Rawl SM. A Randomized Trial to Compare a Tailored Web-Based Intervention and Tailored Phone Counseling to Usual Care for Increasing Colorectal Cancer Screening. Cancer Epidemiol Biomarkers Prev. 2018 Dec;27(12):1433-1441. doi: 10.1158/1055-9965.EPI-18-0180. Epub 2018 Sep 4.
PMID: 30181203
citation: Miller DP Jr, Denizard-Thompson N, Weaver KE, Case LD, Troyer JL, Spangler JG, Lawler D, Pignone MP. Effect of a Digital Health Intervention on Receipt of Colorectal Cancer Screening in Vulnerable Patients: A Randomized Controlled Trial. Ann Intern Med. 2018 Apr 17;168(8):550-557. doi: 10.7326/M17-2315. Epub 2018 Mar 13.
PMID: 29532054
citation: Christy SM, Rawl SM. Shared decision-making about colorectal cancer screening: a conceptual framework to guide research. Patient Educ Couns. 2013 Jun;91(3):310-7. doi: 10.1016/j.pec.2013.01.015. Epub 2013 Feb 15.
PMID: 23419327
citation: Schroy PC 3rd, Duhovic E, Chen CA, Heeren TC, Lopez W, Apodaca DL, Wong JB. Risk Stratification and Shared Decision Making for Colorectal Cancer Screening: A Randomized Controlled Trial. Med Decis Making. 2016 May;36(4):526-35. doi: 10.1177/0272989X15625622. Epub 2016 Jan 19.
PMID: 26785715
citation: Han PK, Duarte CW, Daggett S, Siewers A, Killam B, Smith KA, Freedman AN. Effects of personalized colorectal cancer risk information on laypersons' interest in colorectal cancer screening: The importance of individual differences. Patient Educ Couns. 2015 Oct;98(10):1280-6. doi: 10.1016/j.pec.2015.07.010. Epub 2015 Jul 19.
PMID: 26227576
citation: Vernon SW, Bartholomew LK, McQueen A, Bettencourt JL, Greisinger A, Coan SP, Lairson D, Chan W, Hawley ST, Myers RE. A randomized controlled trial of a tailored interactive computer-delivered intervention to promote colorectal cancer screening: sometimes more is just the same. Ann Behav Med. 2011 Jun;41(3):284-99. doi: 10.1007/s12160-010-9258-5.
PMID: 21271365
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responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Uri Ladabaum
investigator title: Professor of Medicine, Director GI Cancer Prevention Program
mesh term: Colorectal Neoplasms
sharing ipd: Yes
ipd description: De-identified IPD will be made available to other researchers through a HIPAA compliant data storage system (Stanford Medicine Box) that is password protected
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: 2/1/2019-2/1/2021
ipd access criteria: Research staff solely associated with the study and/or Graduate or Post-Doc students-who are writing related manuscripts - who have been given permission by the Principal Investigator, Uri Ladabaum can submit a request.
provided document: 
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