<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/NCT02217865</url>
  </required_header>
  <id_info>
    <org_study_id>PA13-1002</org_study_id>
    <secondary_id>CE13-04-6855</secondary_id>
    <nct_id>NCT02217865</nct_id>
    <nct_alias>NCT02321488</nct_alias>
  </id_info>
  <brief_title>Patient-Centered Risk Adjusted Surveillance After Curative Resection of Colorectal Cancer</brief_title>
  <official_title>Patient-Centered Risk Adjusted Surveillance After Curative Resection of Colorectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Alliance for Clinical Trials in Oncology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      The long-term goal of this research is to develop new tools to guide patients, caregivers,&#xD;
      and clinicians in making individualized decisions regarding colorectal cancer (CRC)&#xD;
      surveillance. As part of a Patient-Centered Outcomes Research Institute-funded contract,&#xD;
      investigator will analyze surveillance data to determine the effectiveness of CRC&#xD;
      surveillance and recurrence risk taking into account different patient and tumor&#xD;
      characteristics; identify key issues about CRC surveillance important to patients,&#xD;
      caregivers, and clinicians; and integrate the recurrence risk and patient priorities into a&#xD;
      patient-centered, risk stratified surveillance strategy by creating an interactive decision&#xD;
      aid for use by patients and clinicians.&#xD;
&#xD;
      This protocol addresses a formative step in the creation of the interactive decision aid&#xD;
      where patients' information needs and preferences are assessed regarding decisions about&#xD;
      surveillance.&#xD;
&#xD;
      The specific aims of this protocol are:&#xD;
&#xD;
      Phase 1 - To interview patients and their caregivers to determine their concerns, preferences&#xD;
      and key priorities regarding surveillance after curative resection of colorectal cancer, and&#xD;
&#xD;
      Phase 2 - To refine the key priorities identified in phase 1 through focus groups and surveys&#xD;
      with patients and caregivers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      You are being asked to take part in this research study which is conducted at The University&#xD;
      of Texas MD Anderson (&quot;MD Anderson&quot;) and the Harris Health System because you (or someone you&#xD;
      act as a caregiver for) are undergoing follow-up after curative resection of colorectal&#xD;
      cancer.&#xD;
&#xD;
      The goal of this study is to find out the key priorities for patients and their caregivers&#xD;
      when it comes to surveillance after curative resection of colorectal cancer. Your responses&#xD;
      will help develop decision aids to help future colorectal cancer patients make more informed&#xD;
      decisions about surveillance.&#xD;
&#xD;
      If you agree to participate in this study, you will take part in an interview or focus group&#xD;
      in person at MD Anderson, the Harris Health System, or the Alliance. The interview or focus&#xD;
      group is expected to take between 30 minutes and 1 hour. The interview or focus group will be&#xD;
      audiorecorded. Your name or other identifying information will not appear in the transcript.&#xD;
      Adept Word Management, a transcription service that has been approved by the institution, may&#xD;
      transcribe the interviews.&#xD;
&#xD;
      You will be asked questions about:&#xD;
&#xD;
        -  your priorities and concerns about colorectal cancer surveillance&#xD;
&#xD;
        -  what you know about colorectal cancer and surveillance,&#xD;
&#xD;
        -  your cancer and treatment (or the patients'),&#xD;
&#xD;
        -  the impact or inconvenience that surveillance causes,&#xD;
&#xD;
        -  who you think should make decisions about surveillance,&#xD;
&#xD;
        -  your thoughts about different surveillance scenarios,&#xD;
&#xD;
        -  and general questions about your age, race, sex, education, and income level.&#xD;
&#xD;
      Information about you will be collected from the medical records and existing data in a&#xD;
      database of colorectal patients that is used to organize existing information about&#xD;
      colorectal patients to better understand the disease. Information collected will include&#xD;
      things like age, gender, marital status, information about the tumor, type of surgery, and&#xD;
      what treatment was done before and after surgery. There are no other plans to share your&#xD;
      information with others outside the study.&#xD;
&#xD;
      Your participation will be over when the interview is complete. If you are undergoing&#xD;
      follow-up for colorectal cancer, research staff will look at your medical record after the&#xD;
      interview for information about your cancer including tumor characteristics.&#xD;
&#xD;
      Your participation is completely voluntary. Whether you say yes or no will not change your&#xD;
      medical care.&#xD;
&#xD;
      Up to 220 patients and their caregivers will participate in this multicenter study. Up to 190&#xD;
      patients and their caregivers will be enrolled at MD Anderson. Up to 10 patients and their&#xD;
      caregivers will be enrolled at the Harris Health System.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 16, 2014</start_date>
  <completion_date type="Actual">January 13, 2022</completion_date>
  <primary_completion_date type="Actual">January 13, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Effectiveness of Colorectal Cancer (CRC) Surveillance</measure>
    <time_frame>1 day</time_frame>
    <description>Semi-structured interviews and focus groups reviewed to identify themes related to participants' and caregiver's priorities regarding surveillance of colorectal cancer.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">32</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Colorectal Cancer Participants</arm_group_label>
    <description>Colorectal cancer participants undergoing follow-up after curative resection of colorectal cancer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caregivers of Colorectal Cancer Participants</arm_group_label>
    <description>Caregivers of colorectal cancer participants undergoing follow-up after curative resection of colorectal cancer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Interviews - Colorectal Cancer Participants</intervention_name>
    <description>Semi-structured interviews conducted exploring key issues relevant to colorectal cancer surveillance following curative resection. Interviews take between 30 minutes and 1 hour.</description>
    <arm_group_label>Caregivers of Colorectal Cancer Participants</arm_group_label>
    <arm_group_label>Colorectal Cancer Participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Questionnaire completion asking general health and demographic questions.</description>
    <arm_group_label>Colorectal Cancer Participants</arm_group_label>
    <other_name>Survey</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Focus Groups</intervention_name>
    <description>Focus groups conducted with participants and caregivers. Up to 4 focus groups conducted with up to 30 participants each. Focus groups expected to take 30 to 60 minutes.</description>
    <arm_group_label>Caregivers of Colorectal Cancer Participants</arm_group_label>
    <arm_group_label>Colorectal Cancer Participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Interviews - Caregivers of Colorectal Cancer Participants</intervention_name>
    <description>Semi-structured interviews conducted exploring key issues relevant to colorectal cancer surveillance following curative resection. Interviews take between 30 minutes and 1 hour.</description>
    <arm_group_label>Caregivers of Colorectal Cancer Participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients of MD Anderson Colorectal Center and their caregivers recruited by study staff.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 21 or older&#xD;
&#xD;
          2. Able to read and speak English&#xD;
&#xD;
          3. Able to undergo a 30 to 60-minute interview or focus group&#xD;
&#xD;
          4. For phase 1: MD Anderson patient undergoing follow-up for curative resection of stage&#xD;
             I-IV colon or rectal cancer OR caregiver of such a patient&#xD;
&#xD;
          5. For phase 2: Colon or rectal cancer patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        N/A&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>George J. Chang, MD,MS</last_name>
    <role>Study Chair</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Robert Volk, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lyndon B. Johnson General Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77026</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>February 11, 2022</last_update_submitted>
  <last_update_submitted_qc>February 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colorectal Cancer</keyword>
  <keyword>CRC</keyword>
  <keyword>Curative resection of colorectal cancer</keyword>
  <keyword>Caregivers</keyword>
  <keyword>Interviews</keyword>
  <keyword>Focus groups</keyword>
  <keyword>Questionnaires</keyword>
  <keyword>Surveys</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT02217865
org study id: PA13-1002
secondary id: CE13-04-6855
nct id: NCT02217865
nct alias: NCT02321488
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
The long-term goal of this research is to develop new tools to guide patients, caregivers,
      and clinicians in making individualized decisions regarding colorectal cancer (CRC)
      surveillance. As part of a Patient-Centered Outcomes Research Institute-funded contract,
      investigator will analyze surveillance data to determine the effectiveness of CRC
      surveillance and recurrence risk taking into account different patient and tumor
      characteristics; identify key issues about CRC surveillance important to patients,
      caregivers, and clinicians; and integrate the recurrence risk and patient priorities into a
      patient-centered, risk stratified surveillance strategy by creating an interactive decision
      aid for use by patients and clinicians.

      This protocol addresses a formative step in the creation of the interactive decision aid
      where patients' information needs and preferences are assessed regarding decisions about
      surveillance.

      The specific aims of this protocol are:

      Phase 1 - To interview patients and their caregivers to determine their concerns, preferences
      and key priorities regarding surveillance after curative resection of colorectal cancer, and

      Phase 2 - To refine the key priorities identified in phase 1 through focus groups and surveys
      with patients and caregivers.
You are being asked to take part in this research study which is conducted at The University
      of Texas MD Anderson ("MD Anderson") and the Harris Health System because you (or someone you
      act as a caregiver for) are undergoing follow-up after curative resection of colorectal
      cancer.

      The goal of this study is to find out the key priorities for patients and their caregivers
      when it comes to surveillance after curative resection of colorectal cancer. Your responses
      will help develop decision aids to help future colorectal cancer patients make more informed
      decisions about surveillance.

      If you agree to participate in this study, you will take part in an interview or focus group
      in person at MD Anderson, the Harris Health System, or the Alliance. The interview or focus
      group is expected to take between 30 minutes and 1 hour. The interview or focus group will be
      audiorecorded. Your name or other identifying information will not appear in the transcript.
      Adept Word Management, a transcription service that has been approved by the institution, may
      transcribe the interviews.

      You will be asked questions about:

        -  your priorities and concerns about colorectal cancer surveillance

        -  what you know about colorectal cancer and surveillance,

        -  your cancer and treatment (or the patients'),

        -  the impact or inconvenience that surveillance causes,

        -  who you think should make decisions about surveillance,

        -  your thoughts about different surveillance scenarios,

        -  and general questions about your age, race, sex, education, and income level.

      Information about you will be collected from the medical records and existing data in a
      database of colorectal patients that is used to organize existing information about
      colorectal patients to better understand the disease. Information collected will include
      things like age, gender, marital status, information about the tumor, type of surgery, and
      what treatment was done before and after surgery. There are no other plans to share your
      information with others outside the study.

      Your participation will be over when the interview is complete. If you are undergoing
      follow-up for colorectal cancer, research staff will look at your medical record after the
      interview for information about your cancer including tumor characteristics.

      Your participation is completely voluntary. Whether you say yes or no will not change your
      medical care.

      Up to 220 patients and their caregivers will participate in this multicenter study. Up to 190
      patients and their caregivers will be enrolled at MD Anderson. Up to 10 patients and their
      caregivers will be enrolled at the Harris Health System.
observational model: Cohort
time perspective: Prospective
measure: Effectiveness of Colorectal Cancer (CRC) Surveillance
time frame: 1 day
description: Semi-structured interviews and focus groups reviewed to identify themes related to participants' and caregiver's priorities regarding surveillance of colorectal cancer.
arm group label: Colorectal Cancer Participants
description: Colorectal cancer participants undergoing follow-up after curative resection of colorectal cancer.
arm group label: Caregivers of Colorectal Cancer Participants
description: Caregivers of colorectal cancer participants undergoing follow-up after curative resection of colorectal cancer.
intervention type: Behavioral
intervention name: Interviews - Colorectal Cancer Participants
description: Semi-structured interviews conducted exploring key issues relevant to colorectal cancer surveillance following curative resection. Interviews take between 30 minutes and 1 hour.
arm group label: Caregivers of Colorectal Cancer Participants
arm group label: Colorectal Cancer Participants
intervention type: Behavioral
intervention name: Questionnaire
description: Questionnaire completion asking general health and demographic questions.
arm group label: Colorectal Cancer Participants
other name: Survey
intervention type: Behavioral
intervention name: Focus Groups
description: Focus groups conducted with participants and caregivers. Up to 4 focus groups conducted with up to 30 participants each. Focus groups expected to take 30 to 60 minutes.
arm group label: Caregivers of Colorectal Cancer Participants
arm group label: Colorectal Cancer Participants
intervention type: Behavioral
intervention name: Interviews - Caregivers of Colorectal Cancer Participants
description: Semi-structured interviews conducted exploring key issues relevant to colorectal cancer surveillance following curative resection. Interviews take between 30 minutes and 1 hour.
arm group label: Caregivers of Colorectal Cancer Participants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: George J. Chang, MD,MS
role: Study Chair
affiliation: M.D. Anderson Cancer Center
last name: Robert Volk, PHD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
facility: 
facility: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Colorectal Neoplasms