<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/NCT01663870</url>
  </required_header>
  <id_info>
    <org_study_id>2012-0450</org_study_id>
    <nct_id>NCT01663870</nct_id>
  </id_info>
  <brief_title>Technology and Navigation to Improve Survivorship Care</brief_title>
  <official_title>Integrating Technology and Navigation to Improve Survivorship Care in Underserved Populations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>M.D. Anderson Cancer Center</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>
      The goal of this research study to learn about breast cancer survivorship and possible ways&#xD;
      to improve breast cancer survivorship programs using technology.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      Objective 1: Assess breast cancer survivors on the acceptability of and preferences for the&#xD;
      integration of patient navigation and an eHealth technology platform to improve care in the&#xD;
      Survivorship Clinic at Lyndon B. Johnson Hospital.&#xD;
&#xD;
      Objective 2: Assess clinic stakeholders acceptability of and preferences for the integration&#xD;
      of patient navigation and an eHealth technology platform to improve care for breast cancer&#xD;
      patients in the Survivorship Clinic at Lyndon B. Johnson Hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Breast Cancer Survivors:&#xD;
&#xD;
      If patient agrees to take part in this study, they will visit the cancer survivorship clinic&#xD;
      where the following tests and procedures will be performed:&#xD;
&#xD;
        -  Patient will have a 30-60 minute interview where they will be asked about cancer-related&#xD;
           informational needs, feelings about survivorship care plans, and preferred methods of&#xD;
           communication with survivorship clinic staff.&#xD;
&#xD;
        -  Patient will be asked about whether they would use the internet and other technologies&#xD;
           (such as text messages for appointment reminders) as tools in breast cancer&#xD;
           survivorship.&#xD;
&#xD;
        -  Patient will use a web-based tool called HealthATM. HealthATM is a website that is&#xD;
           designed to provide information and tools to help patients better manage their health.&#xD;
           After 10-15 minute session with the website, patient will be asked about how easy the&#xD;
           website was to use and other questions about their session.&#xD;
&#xD;
        -  Patient will complete a short questionnaire at the end of the interview asking about&#xD;
           personal characteristics, how involved they are in their health care, and their&#xD;
           attitudes towards the HealthATM website. It should take about 5 minutes to complete this&#xD;
           questionnaire.&#xD;
&#xD;
      All interviews will be audiorecorded. All audio recordings will be kept for 5 years and then&#xD;
      destroyed. All interview data will be stored in password-protected computers and/or locked&#xD;
      file cabinets. There will be no personal identifying information connected to patient's&#xD;
      interview answers.&#xD;
&#xD;
      Length of Study:&#xD;
&#xD;
      All of the study procedures will take place at one visit. The visit should last about 60&#xD;
      minutes.&#xD;
&#xD;
      This is an investigational study.&#xD;
&#xD;
      Up to 40 participants will be enrolled in this study. All will be enrolled at LBJ General&#xD;
      Hospital.&#xD;
&#xD;
      Clinic Stakeholders:&#xD;
&#xD;
      If clinic staff agree to take part in this study, the following tests and procedures will be&#xD;
      performed:&#xD;
&#xD;
        -  Clinic staff will take part in a 60-90 minute focus group session where they will be&#xD;
           asked about their feelings about survivorship care plans and if they think web-based&#xD;
           eHealth programs would be helpful as tools in breast cancer survivorship.&#xD;
&#xD;
        -  Clinic staff will be asked about any challenges and barriers they feel are facing the&#xD;
           survivorship programs at LBJ.&#xD;
&#xD;
        -  Clinic staff will use a web-based tool called HealthATM. HealthATM is a website that&#xD;
           provides information and tools to help patients better manage their health. After a&#xD;
           10-15 minute session with the website, they will be asked about how easy the website was&#xD;
           to use and other questions about their session.&#xD;
&#xD;
      All focus group sessions will be audiorecorded. All audio recordings will be kept for 5 years&#xD;
      and then destroyed. All focus group data will be stored in password-protected computers&#xD;
      and/or locked file cabinets. There will be no personal identifying information connected to&#xD;
      your focus group answers.&#xD;
&#xD;
      Length of Study:&#xD;
&#xD;
      All of the study procedures will take place at one visit. The visit should last about 60&#xD;
      minutes.&#xD;
&#xD;
      This is an investigational study.&#xD;
&#xD;
      Up to 40 stakeholders will be enrolled in this study. All will be enrolled at LBJ General&#xD;
      Hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>February 2013</start_date>
  <completion_date type="Anticipated">February 2021</completion_date>
  <primary_completion_date type="Anticipated">February 2020</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>Interview Study of Breast Cancer Survivorship Programs Using Technology</measure>
    <time_frame>1 day</time_frame>
    <description>Breast cancer survivors and clinic staff surveys analyzed regarding acceptability of, and preferences for integration of patient navigation and an eHealth technology platform. Focus group and interview transcripts analyzed using ATLAS.ti qualitative analysis software. To analyze these data, constant comparative method used to conduct thematic analysis of transcribed data. As secondary check of breast cancer survivor data, calculation of descriptive statistics for measures administered to survivors following interview (frequencies, means, and standard deviations) including Patient Activation Measure and Systems Usability Scale.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Breast Cancer Survivors</arm_group_label>
    <description>Patients in the LBJ General Hospital Cancer Survivorship Clinic.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clinic Stakeholders</arm_group_label>
    <description>Survivorship clinic stakeholders include clinic nurses, physicians, case managers, oncology patient navigators currently working with those in active treatment, information technology support professionals from the Harris County Hospital District (HCHD).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Audio Recorded Interviews</intervention_name>
    <description>Audio recorded interview at beginning of visit and after using HealthATM website.</description>
    <arm_group_label>Breast Cancer Survivors</arm_group_label>
    <arm_group_label>Clinic Stakeholders</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Focus Group Session</intervention_name>
    <description>Focus group session taking 60-90 minutes.</description>
    <arm_group_label>Clinic Stakeholders</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Website Session</intervention_name>
    <description>10-15 minute session with the HealthATM website.</description>
    <arm_group_label>Breast Cancer Survivors</arm_group_label>
    <arm_group_label>Clinic Stakeholders</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Questionnaire completion at end of audio recorded interview taking about 5 minutes.</description>
    <arm_group_label>Breast Cancer Survivors</arm_group_label>
    <other_name>Survey</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Breast cancer survivors and stakeholders at LBJ General Hospital Cancer Survivorship Clinic&#xD;
        in Houston, Texas&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18-years or older (survivors and stakeholders)&#xD;
&#xD;
          2. Ability to read and speak English or Spanish (survivors)&#xD;
&#xD;
          3. Ability to read and speak English (stakeholders)&#xD;
&#xD;
          4. Active patient at the LBJ General Hospital Survivorship Clinic (survivors only)&#xD;
&#xD;
          5. Previous cancer diagnosis with no evidence of recurrence at 3 years or greater&#xD;
             following initial diagnosis (survivors only)&#xD;
&#xD;
          6. Harris County Hospital District employee offering clinical or administrative support&#xD;
             to the LBJGH Cancer Survivorship Clinic (stakeholders only)&#xD;
&#xD;
          7. Cancer survivors who are at least 6 months from diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1) None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan Peterson, MPH, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lyndon B. Johnson Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77026</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>May 2019</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>May 23, 2019</last_update_submitted>
  <last_update_submitted_qc>May 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cancer Prevention</keyword>
  <keyword>Breast cancer survivors</keyword>
  <keyword>Cancer survivorship clinic</keyword>
  <keyword>eHealth technology</keyword>
  <keyword>Internet</keyword>
  <keyword>HealthATM website</keyword>
  <keyword>Questionnaire</keyword>
  <keyword>Clinic stakeholders</keyword>
  <keyword>Clinic nurses</keyword>
  <keyword>Physicians</keyword>
  <keyword>Case managers</keyword>
  <keyword>Oncology patient navigators</keyword>
  <keyword>Audio recorded interviews</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast 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/NCT01663870
org study id: 2012-0450
nct id: NCT01663870
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this research study to learn about breast cancer survivorship and possible ways
      to improve breast cancer survivorship programs using technology.

      Objectives:

      Objective 1: Assess breast cancer survivors on the acceptability of and preferences for the
      integration of patient navigation and an eHealth technology platform to improve care in the
      Survivorship Clinic at Lyndon B. Johnson Hospital.

      Objective 2: Assess clinic stakeholders acceptability of and preferences for the integration
      of patient navigation and an eHealth technology platform to improve care for breast cancer
      patients in the Survivorship Clinic at Lyndon B. Johnson Hospital.
Breast Cancer Survivors:

      If patient agrees to take part in this study, they will visit the cancer survivorship clinic
      where the following tests and procedures will be performed:

        -  Patient will have a 30-60 minute interview where they will be asked about cancer-related
           informational needs, feelings about survivorship care plans, and preferred methods of
           communication with survivorship clinic staff.

        -  Patient will be asked about whether they would use the internet and other technologies
           (such as text messages for appointment reminders) as tools in breast cancer
           survivorship.

        -  Patient will use a web-based tool called HealthATM. HealthATM is a website that is
           designed to provide information and tools to help patients better manage their health.
           After 10-15 minute session with the website, patient will be asked about how easy the
           website was to use and other questions about their session.

        -  Patient will complete a short questionnaire at the end of the interview asking about
           personal characteristics, how involved they are in their health care, and their
           attitudes towards the HealthATM website. It should take about 5 minutes to complete this
           questionnaire.

      All interviews will be audiorecorded. All audio recordings will be kept for 5 years and then
      destroyed. All interview data will be stored in password-protected computers and/or locked
      file cabinets. There will be no personal identifying information connected to patient's
      interview answers.

      Length of Study:

      All of the study procedures will take place at one visit. The visit should last about 60
      minutes.

      This is an investigational study.

      Up to 40 participants will be enrolled in this study. All will be enrolled at LBJ General
      Hospital.

      Clinic Stakeholders:

      If clinic staff agree to take part in this study, the following tests and procedures will be
      performed:

        -  Clinic staff will take part in a 60-90 minute focus group session where they will be
           asked about their feelings about survivorship care plans and if they think web-based
           eHealth programs would be helpful as tools in breast cancer survivorship.

        -  Clinic staff will be asked about any challenges and barriers they feel are facing the
           survivorship programs at LBJ.

        -  Clinic staff will use a web-based tool called HealthATM. HealthATM is a website that
           provides information and tools to help patients better manage their health. After a
           10-15 minute session with the website, they will be asked about how easy the website was
           to use and other questions about their session.

      All focus group sessions will be audiorecorded. All audio recordings will be kept for 5 years
      and then destroyed. All focus group data will be stored in password-protected computers
      and/or locked file cabinets. There will be no personal identifying information connected to
      your focus group answers.

      Length of Study:

      All of the study procedures will take place at one visit. The visit should last about 60
      minutes.

      This is an investigational study.

      Up to 40 stakeholders will be enrolled in this study. All will be enrolled at LBJ General
      Hospital.
observational model: Cohort
time perspective: Prospective
measure: Interview Study of Breast Cancer Survivorship Programs Using Technology
time frame: 1 day
description: Breast cancer survivors and clinic staff surveys analyzed regarding acceptability of, and preferences for integration of patient navigation and an eHealth technology platform. Focus group and interview transcripts analyzed using ATLAS.ti qualitative analysis software. To analyze these data, constant comparative method used to conduct thematic analysis of transcribed data. As secondary check of breast cancer survivor data, calculation of descriptive statistics for measures administered to survivors following interview (frequencies, means, and standard deviations) including Patient Activation Measure and Systems Usability Scale.
arm group label: Breast Cancer Survivors
description: Patients in the LBJ General Hospital Cancer Survivorship Clinic.
arm group label: Clinic Stakeholders
description: Survivorship clinic stakeholders include clinic nurses, physicians, case managers, oncology patient navigators currently working with those in active treatment, information technology support professionals from the Harris County Hospital District (HCHD).
intervention type: Behavioral
intervention name: Audio Recorded Interviews
description: Audio recorded interview at beginning of visit and after using HealthATM website.
arm group label: Breast Cancer Survivors
arm group label: Clinic Stakeholders
intervention type: Behavioral
intervention name: Focus Group Session
description: Focus group session taking 60-90 minutes.
arm group label: Clinic Stakeholders
intervention type: Other
intervention name: Website Session
description: 10-15 minute session with the HealthATM website.
arm group label: Breast Cancer Survivors
arm group label: Clinic Stakeholders
intervention type: Behavioral
intervention name: Questionnaire
description: Questionnaire completion at end of audio recorded interview taking about 5 minutes.
arm group label: Breast Cancer Survivors
other name: Survey
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Susan Peterson, MPH, PhD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Breast Neoplasms