<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/NCT03801954</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00142651</org_study_id>
    <nct_id>NCT03801954</nct_id>
  </id_info>
  <brief_title>Implementation of Nutrition Education Videos for Patients Undergoing Radical Cystectomy</brief_title>
  <official_title>Implementation of Nutrition Education Videos for Patients Undergoing Radical Cystectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kansas Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kansas Medical 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>
      By doing this study the investigators hope to learn if educational videos focusing on&#xD;
      nutrition for bladder cancer patients are a good and effective way to help people improve&#xD;
      their nutrition and recovery after radical cystectomy (RC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bladder Cancer is the fifth most common cancer in the USA. The primary treatment for invasive&#xD;
      bladder cancer is chemotherapy followed by RC. Patients undergoing this surgery are at risk&#xD;
      for complications. Being malnourished can increase the risk of mortality by three times. The&#xD;
      patients also suffer from taste alterations after chemotherapy and gastrointestinal&#xD;
      disturbances such as diarrhea and constipation. These can lead to poor nutritional intake and&#xD;
      malabsorption of nutrients.&#xD;
&#xD;
      This study is being done to develop an educational video series for patients undergoing RC&#xD;
      and assess their impact. The videos are created to address the nutritional needs of these&#xD;
      patients and improve their outcomes after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 28, 2018</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</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>Evaluate content of three educational video series</measure>
    <time_frame>Week 2</time_frame>
    <description>Evaluate the content of three video series focusing on practical solutions to nutritional problems common to patients undergoing a radical cystectomy through iterative process using Center for Disease Control's Clear Communication Index. The Center for Disease Control's Clear Communication Index uses 4 questions and 20 scored items to asses how materials enhance and aid people's understanding of information in seven areas - main message and call to action, language, information design, state of the science, behavioral recommendations, numbers, and risk. The range of scores is 0 to 100 with a score of 90 or higher considered a passing score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Feedback Regarding Videos</measure>
    <time_frame>Week 2</time_frame>
    <description>After viewing the videos semi-structure interviews of participants will be conducted to obtain feedback regarding the videos content and design.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Attention During Videos</measure>
    <time_frame>Week 2</time_frame>
    <description>Eye tracking of participants will be used to assess attention of participants during the videos in order to best understand how participants are viewing the videos and responding to them.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Test feedback instrument with patients</measure>
    <time_frame>Week 2</time_frame>
    <description>Use a pretest developed instrument measuring nutrition knowledge to test participants knowledge before and after watching the videos</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess implantation of video series</measure>
    <time_frame>Week 2</time_frame>
    <description>Online survey of viewers will be used to gain feedback on how the videos were received by those who watched them</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">15</enrollment>
  <condition>Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>RC Patients</arm_group_label>
    <description>Patients at the University of Kansas Medical Center who have not yet had their radical cystectomy, after their radical cystectomy, or between the completion of chemotherapy and the radical cystectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Educational Videos</intervention_name>
    <description>15 videos that are about 3 minutes long each and cover nutritional advice for patients with bladder cancer undergoing RC and/or chemotherapy.</description>
    <arm_group_label>RC Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who present to the University of Kansas Urology clinic for bladder cancer will be&#xD;
        screened for participation in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with bladder cancer and scheduled to undergo a radical cystectomy or has&#xD;
             undergone a radical cystectomy OR be the caregiver of a patient diagnosed with bladder&#xD;
             cancer who is scheduled to undergo a radical cystectomy or has undergone a radical&#xD;
             cystectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Patients who are under 18 years old are not allowed to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eugene Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kansas Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 2, 2018</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>May 11, 2023</last_update_submitted>
  <last_update_submitted_qc>May 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nutrition</keyword>
  <keyword>Diet</keyword>
  <keyword>Radical cystectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder 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/NCT03801954
org study id: STUDY00142651
nct id: NCT03801954
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
By doing this study the investigators hope to learn if educational videos focusing on
      nutrition for bladder cancer patients are a good and effective way to help people improve
      their nutrition and recovery after radical cystectomy (RC).
Bladder Cancer is the fifth most common cancer in the USA. The primary treatment for invasive
      bladder cancer is chemotherapy followed by RC. Patients undergoing this surgery are at risk
      for complications. Being malnourished can increase the risk of mortality by three times. The
      patients also suffer from taste alterations after chemotherapy and gastrointestinal
      disturbances such as diarrhea and constipation. These can lead to poor nutritional intake and
      malabsorption of nutrients.

      This study is being done to develop an educational video series for patients undergoing RC
      and assess their impact. The videos are created to address the nutritional needs of these
      patients and improve their outcomes after surgery.
observational model: Cohort
time perspective: Prospective
measure: Evaluate content of three educational video series
time frame: Week 2
description: Evaluate the content of three video series focusing on practical solutions to nutritional problems common to patients undergoing a radical cystectomy through iterative process using Center for Disease Control's Clear Communication Index. The Center for Disease Control's Clear Communication Index uses 4 questions and 20 scored items to asses how materials enhance and aid people's understanding of information in seven areas - main message and call to action, language, information design, state of the science, behavioral recommendations, numbers, and risk. The range of scores is 0 to 100 with a score of 90 or higher considered a passing score.
measure: Patient Feedback Regarding Videos
time frame: Week 2
description: After viewing the videos semi-structure interviews of participants will be conducted to obtain feedback regarding the videos content and design.
measure: Patient Attention During Videos
time frame: Week 2
description: Eye tracking of participants will be used to assess attention of participants during the videos in order to best understand how participants are viewing the videos and responding to them.
measure: Test feedback instrument with patients
time frame: Week 2
description: Use a pretest developed instrument measuring nutrition knowledge to test participants knowledge before and after watching the videos
measure: Assess implantation of video series
time frame: Week 2
description: Online survey of viewers will be used to gain feedback on how the videos were received by those who watched them
arm group label: RC Patients
description: Patients at the University of Kansas Medical Center who have not yet had their radical cystectomy, after their radical cystectomy, or between the completion of chemotherapy and the radical cystectomy.
intervention type: Behavioral
intervention name: Educational Videos
description: 15 videos that are about 3 minutes long each and cover nutritional advice for patients with bladder cancer undergoing RC and/or chemotherapy.
arm group label: RC Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eugene Lee, MD
role: Principal Investigator
affiliation: University of Kansas Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Urinary Bladder Neoplasms