<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/NCT03279198</url>
  </required_header>
  <id_info>
    <org_study_id>1009001808</org_study_id>
    <secondary_id>5R01CA136940-05</secondary_id>
    <nct_id>NCT03279198</nct_id>
  </id_info>
  <brief_title>Increasing Colorectal and Breast Cancer Screening in Women</brief_title>
  <acronym>COBRA</acronym>
  <official_title>Increasing Colorectal and Breast Cancer Screening in Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Indiana 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 compares the efficacy (adherence and stage) of four interventions to promote&#xD;
      colorectal (CRC) and breast cancer (BC) screenings among women ages 50 to 75. They are:&#xD;
&#xD;
        1. usual care;&#xD;
&#xD;
        2. a TIWeb (tailored intervention Website)&#xD;
&#xD;
        3. a CSC (cancer screening call) and&#xD;
&#xD;
        4. TIWeb + a CSC. This study also compares the cost-effectiveness of the 4 interventions to&#xD;
           promote CRC and BC screening among women ages 50 to 75.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study addresses innovative approaches to increase adherence to screening tests for&#xD;
      colorectal and breast cancer - two cancers that have the greatest impact on female cancer&#xD;
      mortality in the United States.The cancer burden in women could be significantly reduced by&#xD;
      increasing participation in recommended screening for colorectal cancer (CRC) and breast&#xD;
      cancer (BC) in all eligible women. This research tests intervention to simultaneously&#xD;
      increase both CRC and BC screening using behavior change strategies, and also estimates the&#xD;
      efficacy and cost-effectiveness of the interventions. Two groups of women, Group A (adherent&#xD;
      to BC screening guidelines, but NOT to CRC screening guidelines) and Group B (non-adherent to&#xD;
      BC &amp; CRC guidelines) are randomized to 1. Usual Care, 2. TIWeb, 3. CSC and 4. TIWeb +CSC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 22, 2010</start_date>
  <completion_date type="Actual">May 31, 2017</completion_date>
  <primary_completion_date type="Actual">September 15, 2015</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>Factorial Assignment</intervention_model>
    <intervention_model_description>We propose a prospective randomized 2x2 factorial design: 1)usual care; 2) a TIWeb; 3) a Cancer Screening Call (CSC), and 4 a TIWEB+ a Cancer Screening Call (CSC). The intervention will be tested in 2 groups of women. Group A will include women who are nonadherent to CRC but adherent to BC screening guidelines. Group B will include women who are nonadherent to both CRC and BC screening guidelines.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Outcome -differences in CRC screening adherence, when controlling for adherence to BC screening at baseline, among women who are randomized to 1) usual care; 2) a TIWeb; 3) a CSC, and 4) a TIWeb plus a CSC.</measure>
    <time_frame>6 months from the baseline measure</time_frame>
    <description>any CRC test (either a stool test or colonoscopy) receipt of a stool test or a colonoscopy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary Outcome:differences in stage of adoption (precontemplation, contemplation, action) when controlling for adherence to BC screening at baseline, among women who are randomized to 1) usual care; 2) a TIWeb; 3) a CSC, and 4) a TIWeb plus a CSC.</measure>
    <time_frame>6 months from the baseline measure</time_frame>
    <description>Forward stage movement is the desired outcome -determining any forward stage movement in considering CRC screening either from Precontemplation to contemplation or from precontemplation to action</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary outcome:Intervention Costs</measure>
    <time_frame>6 months from the baseline measure</time_frame>
    <description>Comparing the cost-effectiveness of four conditions to promote CRC and BC screening , there will be differences in adherence to both CRC and BC screening and stage of adoption, among women who are randomized to 1) usual care; 2) a TIWeb; 3) a CSC, and 4) a TIWeb plus a CSC.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">1196</enrollment>
  <condition>Breast Cancer Female</condition>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Usual Care (UC)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The usual care group received usual care that varies dependent upon the practice setting.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TIWeb</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TIWeb (Tailored Web Intervention) program is interactive and tailored to the participant's individual beliefs and demographics. Individuals receiving the TIWeb will be given information that allows them to call and receive an FOBT kit in the mail or schedule an appropriate CRC test and/or mammogram.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cancer Screening Call (CSC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CSC - a telephone counseling call during which the participant is given the opportunity to complete CRC screening (FOBT or a colonoscopy) and/or mammography screening.The CSC included tailored counseling as well as the ability to schedule BC and CRC screening tests.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TIWeb+CSC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TIWeb + CSC ((Tailored web intervetion+Cancer screening) group receive a mailed TIWeb, which is followed in four weeks by a CSC with the same opportunity to receive FOBT kits or schedule a colonoscopy and/or mammogram. The nurse counselor, knowing the participant is a good candidate for screening tests, will be trained to schedule CRC or BC screening appointments or to mail FOBT kits to individuals in the intervention groups even if they have not had a recent clinic visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TIWeb</intervention_name>
    <description>Intervention: TIWeb program is interactive and tailored to the participant's individual beliefs and demographics. Individuals receiving the TIWeb will be given information that allows them to call and receive an FOBT kit in the mail or schedule an appropriate CRC test and/or mammogram.</description>
    <arm_group_label>TIWeb</arm_group_label>
    <other_name>Tailored Web Intervention</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CSC</intervention_name>
    <description>Intervention: CSC - a telephone counseling call during which the participant is given the opportunity to complete CRC screening (FOBT or a colonoscopy) and/or mammography screening.The CSC included tailored counseling as well as the ability to schedule BC and CRC screening tests.</description>
    <arm_group_label>Cancer Screening Call (CSC)</arm_group_label>
    <other_name>Cancer Screening Call</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>UC</intervention_name>
    <description>Intervention: The usual care group received usual care that varies dependent upon the practice setting.</description>
    <arm_group_label>Usual Care (UC)</arm_group_label>
    <other_name>Usual Care</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TIWeb+CSC</intervention_name>
    <description>Intervention: TIWeb + CSC ((Tailored web intervetion+Cancer screening) group receive a mailed TIWeb, which is followed in four weeks by a CSC with the same opportunity to receive FOBT kits or schedule a colonoscopy and/or mammogram. The nurse counselor, knowing the participant is a good candidate for screening tests, will be trained to schedule CRC or BC screening appointments or to mail FOBT kits to individuals in the intervention groups even if they have not had a recent clinic visit.</description>
    <arm_group_label>TIWeb+CSC</arm_group_label>
    <other_name>Tailored Web Intervention + Cancer Screening Call</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a patient of any of the participating physicians&#xD;
&#xD;
          -  not having had a fecal occult blood test (fobt) in the last 12 months&#xD;
&#xD;
          -  not having had a fecal immunochemical test (fit) in the past 15 months&#xD;
&#xD;
          -  not having had sigmoidoscopy more than 5 years ago&#xD;
&#xD;
          -  not having had a colonoscopy more than 10 years ago&#xD;
&#xD;
          -  have high-speed internet access&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  a personal history of colorectal cancer&#xD;
&#xD;
          -  a personal history of breast cancer&#xD;
&#xD;
          -  a personal history of colorectal polyps&#xD;
&#xD;
          -  a personal history of inflammatory bowel disease&#xD;
&#xD;
          -  having any medical conditions that would prohibit a mammogram or CRC screening&#xD;
&#xD;
          -  have already had CRC screening&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Women between the ages from 50 - 75.</gender_description>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Victoria Champion, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University School of Medicine</affiliation>
  </overall_official>
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  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 8, 2017</last_update_submitted>
  <last_update_submitted_qc>September 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Victoria L. Champion</investigator_full_name>
    <investigator_title>Distinguished Professor Edward and Sara Stam Culliper named Professor Associate Director Cancer Prevention and Control</investigator_title>
  </responsible_party>
  <keyword>breast cancer screening</keyword>
  <keyword>colorectal cancer screening</keyword>
  <keyword>cervical cancer screening</keyword>
  <keyword>cancer screening beliefs</keyword>
  <keyword>cost-effectiveness</keyword>
  <keyword>demographics</keyword>
  <keyword>tailored intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <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 (Box Health) that is password protected.</ipd_description>
    <ipd_info_type>Study Protocol</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>January 1st, 2017 - March 31st, 2020.</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, Victoria Champion can submit a request.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <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>January 24, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT03279198/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <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>June 11, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT03279198/ICF_001.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/NCT03279198
org study id: 1009001808
secondary id: 5R01CA136940-05
nct id: NCT03279198
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study compares the efficacy (adherence and stage) of four interventions to promote
      colorectal (CRC) and breast cancer (BC) screenings among women ages 50 to 75. They are:

        1. usual care;

        2. a TIWeb (tailored intervention Website)

        3. a CSC (cancer screening call) and

        4. TIWeb + a CSC. This study also compares the cost-effectiveness of the 4 interventions to
           promote CRC and BC screening among women ages 50 to 75.
This study addresses innovative approaches to increase adherence to screening tests for
      colorectal and breast cancer - two cancers that have the greatest impact on female cancer
      mortality in the United States.The cancer burden in women could be significantly reduced by
      increasing participation in recommended screening for colorectal cancer (CRC) and breast
      cancer (BC) in all eligible women. This research tests intervention to simultaneously
      increase both CRC and BC screening using behavior change strategies, and also estimates the
      efficacy and cost-effectiveness of the interventions. Two groups of women, Group A (adherent
      to BC screening guidelines, but NOT to CRC screening guidelines) and Group B (non-adherent to
      BC & CRC guidelines) are randomized to 1. Usual Care, 2. TIWeb, 3. CSC and 4. TIWeb +CSC.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: We propose a prospective randomized 2x2 factorial design: 1)usual care; 2) a TIWeb; 3) a Cancer Screening Call (CSC), and 4 a TIWEB+ a Cancer Screening Call (CSC). The intervention will be tested in 2 groups of women. Group A will include women who are nonadherent to CRC but adherent to BC screening guidelines. Group B will include women who are nonadherent to both CRC and BC screening guidelines.
primary purpose: Prevention
masking: None (Open Label)
measure: Primary Outcome -differences in CRC screening adherence, when controlling for adherence to BC screening at baseline, among women who are randomized to 1) usual care; 2) a TIWeb; 3) a CSC, and 4) a TIWeb plus a CSC.
time frame: 6 months from the baseline measure
description: any CRC test (either a stool test or colonoscopy) receipt of a stool test or a colonoscopy
measure: Primary Outcome:differences in stage of adoption (precontemplation, contemplation, action) when controlling for adherence to BC screening at baseline, among women who are randomized to 1) usual care; 2) a TIWeb; 3) a CSC, and 4) a TIWeb plus a CSC.
time frame: 6 months from the baseline measure
description: Forward stage movement is the desired outcome -determining any forward stage movement in considering CRC screening either from Precontemplation to contemplation or from precontemplation to action
measure: Secondary outcome:Intervention Costs
time frame: 6 months from the baseline measure
description: Comparing the cost-effectiveness of four conditions to promote CRC and BC screening , there will be differences in adherence to both CRC and BC screening and stage of adoption, among women who are randomized to 1) usual care; 2) a TIWeb; 3) a CSC, and 4) a TIWeb plus a CSC.
arm group label: Usual Care (UC)
arm group type: Placebo Comparator
description: The usual care group received usual care that varies dependent upon the practice setting.
arm group label: TIWeb
arm group type: Active Comparator
description: TIWeb (Tailored Web Intervention) program is interactive and tailored to the participant's individual beliefs and demographics. Individuals receiving the TIWeb will be given information that allows them to call and receive an FOBT kit in the mail or schedule an appropriate CRC test and/or mammogram.
arm group label: Cancer Screening Call (CSC)
arm group type: Active Comparator
description: CSC - a telephone counseling call during which the participant is given the opportunity to complete CRC screening (FOBT or a colonoscopy) and/or mammography screening.The CSC included tailored counseling as well as the ability to schedule BC and CRC screening tests.
arm group label: TIWeb+CSC
arm group type: Active Comparator
description: TIWeb + CSC ((Tailored web intervetion+Cancer screening) group receive a mailed TIWeb, which is followed in four weeks by a CSC with the same opportunity to receive FOBT kits or schedule a colonoscopy and/or mammogram. The nurse counselor, knowing the participant is a good candidate for screening tests, will be trained to schedule CRC or BC screening appointments or to mail FOBT kits to individuals in the intervention groups even if they have not had a recent clinic visit.
intervention type: Behavioral
intervention name: TIWeb
description: Intervention: TIWeb program is interactive and tailored to the participant's individual beliefs and demographics. Individuals receiving the TIWeb will be given information that allows them to call and receive an FOBT kit in the mail or schedule an appropriate CRC test and/or mammogram.
arm group label: TIWeb
other name: Tailored Web Intervention
intervention type: Behavioral
intervention name: CSC
description: Intervention: CSC - a telephone counseling call during which the participant is given the opportunity to complete CRC screening (FOBT or a colonoscopy) and/or mammography screening.The CSC included tailored counseling as well as the ability to schedule BC and CRC screening tests.
arm group label: Cancer Screening Call (CSC)
other name: Cancer Screening Call
intervention type: Behavioral
intervention name: UC
description: Intervention: The usual care group received usual care that varies dependent upon the practice setting.
arm group label: Usual Care (UC)
other name: Usual Care
intervention type: Behavioral
intervention name: TIWeb+CSC
description: Intervention: TIWeb + CSC ((Tailored web intervetion+Cancer screening) group receive a mailed TIWeb, which is followed in four weeks by a CSC with the same opportunity to receive FOBT kits or schedule a colonoscopy and/or mammogram. The nurse counselor, knowing the participant is a good candidate for screening tests, will be trained to schedule CRC or BC screening appointments or to mail FOBT kits to individuals in the intervention groups even if they have not had a recent clinic visit.
arm group label: TIWeb+CSC
other name: Tailored Web Intervention + Cancer Screening Call
criteria: 
gender: Female
gender based: Yes
gender description: Women between the ages from 50 - 75.
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Victoria Champion, PhD
role: Principal Investigator
affiliation: Indiana University School of Medicine
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responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Victoria L. Champion
investigator title: Distinguished Professor Edward and Sara Stam Culliper named Professor Associate Director Cancer Prevention and Control
mesh term: Breast Neoplasms
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 (Box Health) that is password protected.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: January 1st, 2017 - March 31st, 2020.
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, Victoria Champion can submit a request.
provided document: 
provided document: 