<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/NCT04469478</url>
  </required_header>
  <id_info>
    <org_study_id>20-0560.cc</org_study_id>
    <nct_id>NCT04469478</nct_id>
  </id_info>
  <brief_title>Virtual Reality in Imaging Review for Cancer Patients</brief_title>
  <official_title>The Use of Virtual Reality for Diagnostic Imaging Review With Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Colorado State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Patients with cancer and their caregivers may have difficulty understanding the site and&#xD;
      extent of their disease. Poor comprehension may negatively impact patients and caregivers,&#xD;
      leading to increased anxiety, reduced compliance, decreased trust of the physician, and&#xD;
      limited shared medical decision making ability. Most patients want to be thoroughly informed,&#xD;
      with over a third of cancer patients wishing they had been better informed about side effects&#xD;
      that they experienced due to their treatment. The purpose of this study is to evaluate the&#xD;
      impact of diagnostic imaging review using 3D virtual reality compared to standard 2D imaging&#xD;
      review for patients and their caregiver(s) using a mixed methods approach of survey and&#xD;
      qualitative interview based approaches.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will use virtual reality to display the patient's diagnostic imaging in 3D with&#xD;
      live volumetric rendering. This study will explore if this approach improves patient and&#xD;
      caregiver understanding of their disease. Eligible patients should have available diagnostic&#xD;
      imaging consisting of CT, MRI, and/or PET-CT. Prior to their consultation in radiation&#xD;
      oncology, patients will complete a survey about their prior experience reviewing their&#xD;
      diagnostic imaging. During the consultation, patients and caregivers will be shown their&#xD;
      medical imaging in 2D on a computer screen, then in 3D with virtual reality. After the&#xD;
      consultation, the patient and caregiver(s) will complete a 2nd survey comparing virtual&#xD;
      reality to standard imaging review with domains of perceived understanding, patient&#xD;
      preference, and satisfaction. Then, the patient and caregiver(s) will undergo a qualitative&#xD;
      interview exploring their experience with virtual reality compared to standard imaging&#xD;
      review. The survey questions comparing virtual reality to standard imaging review will be&#xD;
      statistically evaluated. The recorded interview session will be qualitatively analyzed using&#xD;
      with a mixed methods approach by thematically categorizing the respondents' answers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study was not approved in 2020 secondary to COVID-19 restrictions on trials&#xD;
  </why_stopped>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single Arm Exploratory Study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Successful Completion of Imaging Review Using Virtual Reality</measure>
    <time_frame>During the consultation 1 day visit</time_frame>
    <description>The percentage of patients able to complete the review of their imaging using virtual reality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Satisfaction and preference</measure>
    <time_frame>During the consultation 1 day visit</time_frame>
    <description>Evaluate patients' and caregivers' satisfaction and preferences regarding diagnostic imaging review using a focused survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Qualitative feedback regarding imaging review using virtual reality</measure>
    <time_frame>During the consultation 1 day visit</time_frame>
    <description>Collect patients' and caregivers' feedback regarding imaging review using virtual reality through qualitative interviews.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline demographics and imaging review experience</measure>
    <time_frame>During the consultation 1 day visit</time_frame>
    <description>Capture baseline demographics, education, and prior experience with diagnostic imaging review.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervention time interval</measure>
    <time_frame>During the consultation 1 day visit</time_frame>
    <description>Measure the time spent reviewing diagnostic imaging with virtual reality and standard approaches relative to the consultation time</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Patient Education</condition>
  <condition>Virtual Reality</condition>
  <condition>Diagnostic Imaging</condition>
  <condition>Cancer Patient</condition>
  <arm_group>
    <arm_group_label>Virtual Reality for imaging review</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each participant (patient and caregiver(s)) will undergo standard 2D imaging review on a computer screen, followed by 3D imaging review in virtual reality during their radiation oncology consultation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey and interview</intervention_name>
    <description>Patients and caregivers will provide information via surveys and interviews regarding their experience viewing diagnostic imaging using conventional methods and using Virtual Reality</description>
    <arm_group_label>Virtual Reality for imaging review</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willingness to sign and date the consent form.&#xD;
&#xD;
          -  Willingness to comply with all study procedures and be available for the duration of&#xD;
             the study.&#xD;
&#xD;
          -  Male or female patient 18 years or older.&#xD;
&#xD;
          -  Available diagnostic imaging (MRI, CT and/or PET)&#xD;
&#xD;
          -  Consultation in radiation oncology for consideration of radiation therapy.&#xD;
&#xD;
          -  English speaking.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to complete virtual reality, survey and interview.&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Patients with visual defects that affect their ability to view content in VR&#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>
  <location>
    <facility>
      <name>University of Colorado, Anschutz Cancer Center</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Fernsler JI, Cannon CA. The whys of patient education. Semin Oncol Nurs. 1991 May;7(2):79-86. doi: 10.1016/0749-2081(91)90085-4.</citation>
    <PMID>1882153</PMID>
  </reference>
  <reference>
    <citation>Gold DT, McClung B. Approaches to patient education: emphasizing the long-term value of compliance and persistence. Am J Med. 2006 Apr;119(4 Suppl 1):S32-7. doi: 10.1016/j.amjmed.2005.12.021.</citation>
    <PMID>16563940</PMID>
  </reference>
  <reference>
    <citation>Hess CB, Chen AM. Measuring psychosocial functioning in the radiation oncology clinic: a systematic review. Psychooncology. 2014 Aug;23(8):841-54. doi: 10.1002/pon.3521. Epub 2014 May 21.</citation>
    <PMID>24846702</PMID>
  </reference>
  <reference>
    <citation>Takahashi T, Hondo M, Nishimura K, Kitani A, Yamano T, Yanagita H, Osada H, Shinbo M, Honda N. Evaluation of quality of life and psychological response in cancer patients treated with radiotherapy. Radiat Med. 2008 Aug;26(7):396-401. doi: 10.1007/s11604-008-0248-5. Epub 2008 Sep 4.</citation>
    <PMID>18769996</PMID>
  </reference>
  <reference>
    <citation>Johnson A, Sandford J. Written and verbal information versus verbal information only for patients being discharged from acute hospital settings to home: systematic review. Health Educ Res. 2005 Aug;20(4):423-9. doi: 10.1093/her/cyg141. Epub 2004 Nov 30.</citation>
    <PMID>15572437</PMID>
  </reference>
  <reference>
    <citation>Theis SL, Johnson JH. Strategies for teaching patients: a meta-analysis. Clin Nurse Spec. 1995 Mar;9(2):100-5, 120. doi: 10.1097/00002800-199503000-00010.</citation>
    <PMID>7600475</PMID>
  </reference>
  <reference>
    <citation>Friedman AJ, Cosby R, Boyko S, Hatton-Bauer J, Turnbull G. Effective teaching strategies and methods of delivery for patient education: a systematic review and practice guideline recommendations. J Cancer Educ. 2011 Mar;26(1):12-21. doi: 10.1007/s13187-010-0183-x.</citation>
    <PMID>21161465</PMID>
  </reference>
  <reference>
    <citation>Press Ganey: public reporting gives huge boost to patient satisfaction. Healthcare Benchmarks Qual Improv. 2008 Dec;15(12):121-3.</citation>
    <PMID>19024286</PMID>
  </reference>
  <reference>
    <citation>Meredith C, Symonds P, Webster L, Lamont D, Pyper E, Gillis CR, Fallowfield L. Information needs of cancer patients in west Scotland: cross sectional survey of patients' views. BMJ. 1996 Sep 21;313(7059):724-6. doi: 10.1136/bmj.313.7059.724.</citation>
    <PMID>8819442</PMID>
  </reference>
  <reference>
    <citation>Shaverdian N, Yeboa DN, Gardner L, Harari PM, Liao K, McCloskey S, Tuli R, Vapiwala N, Jagsi R. Nationwide Survey of Patients' Perspectives Regarding Their Radiation and Multidisciplinary Cancer Treatment Experiences. J Oncol Pract. 2019 Dec;15(12):e1010-e1017. doi: 10.1200/JOP.19.00376. Epub 2019 Nov 20.</citation>
    <PMID>31747336</PMID>
  </reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>November 1, 2021</last_update_submitted>
  <last_update_submitted_qc>November 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04469478
org study id: 20-0560.cc
nct id: NCT04469478
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Patients with cancer and their caregivers may have difficulty understanding the site and
      extent of their disease. Poor comprehension may negatively impact patients and caregivers,
      leading to increased anxiety, reduced compliance, decreased trust of the physician, and
      limited shared medical decision making ability. Most patients want to be thoroughly informed,
      with over a third of cancer patients wishing they had been better informed about side effects
      that they experienced due to their treatment. The purpose of this study is to evaluate the
      impact of diagnostic imaging review using 3D virtual reality compared to standard 2D imaging
      review for patients and their caregiver(s) using a mixed methods approach of survey and
      qualitative interview based approaches.
This study will use virtual reality to display the patient's diagnostic imaging in 3D with
      live volumetric rendering. This study will explore if this approach improves patient and
      caregiver understanding of their disease. Eligible patients should have available diagnostic
      imaging consisting of CT, MRI, and/or PET-CT. Prior to their consultation in radiation
      oncology, patients will complete a survey about their prior experience reviewing their
      diagnostic imaging. During the consultation, patients and caregivers will be shown their
      medical imaging in 2D on a computer screen, then in 3D with virtual reality. After the
      consultation, the patient and caregiver(s) will complete a 2nd survey comparing virtual
      reality to standard imaging review with domains of perceived understanding, patient
      preference, and satisfaction. Then, the patient and caregiver(s) will undergo a qualitative
      interview exploring their experience with virtual reality compared to standard imaging
      review. The survey questions comparing virtual reality to standard imaging review will be
      statistically evaluated. The recorded interview session will be qualitatively analyzed using
      with a mixed methods approach by thematically categorizing the respondents' answers.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single Arm Exploratory Study
primary purpose: Treatment
masking: None (Open Label)
measure: Successful Completion of Imaging Review Using Virtual Reality
time frame: During the consultation 1 day visit
description: The percentage of patients able to complete the review of their imaging using virtual reality
measure: Satisfaction and preference
time frame: During the consultation 1 day visit
description: Evaluate patients' and caregivers' satisfaction and preferences regarding diagnostic imaging review using a focused survey
measure: Qualitative feedback regarding imaging review using virtual reality
time frame: During the consultation 1 day visit
description: Collect patients' and caregivers' feedback regarding imaging review using virtual reality through qualitative interviews.
measure: Baseline demographics and imaging review experience
time frame: During the consultation 1 day visit
description: Capture baseline demographics, education, and prior experience with diagnostic imaging review.
measure: Intervention time interval
time frame: During the consultation 1 day visit
description: Measure the time spent reviewing diagnostic imaging with virtual reality and standard approaches relative to the consultation time
arm group label: Virtual Reality for imaging review
arm group type: Experimental
description: Each participant (patient and caregiver(s)) will undergo standard 2D imaging review on a computer screen, followed by 3D imaging review in virtual reality during their radiation oncology consultation
intervention type: Other
intervention name: Survey and interview
description: Patients and caregivers will provide information via surveys and interviews regarding their experience viewing diagnostic imaging using conventional methods and using Virtual Reality
arm group label: Virtual Reality for imaging review
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: Fernsler JI, Cannon CA. The whys of patient education. Semin Oncol Nurs. 1991 May;7(2):79-86. doi: 10.1016/0749-2081(91)90085-4.
PMID: 1882153
citation: Gold DT, McClung B. Approaches to patient education: emphasizing the long-term value of compliance and persistence. Am J Med. 2006 Apr;119(4 Suppl 1):S32-7. doi: 10.1016/j.amjmed.2005.12.021.
PMID: 16563940
citation: Hess CB, Chen AM. Measuring psychosocial functioning in the radiation oncology clinic: a systematic review. Psychooncology. 2014 Aug;23(8):841-54. doi: 10.1002/pon.3521. Epub 2014 May 21.
PMID: 24846702
citation: Takahashi T, Hondo M, Nishimura K, Kitani A, Yamano T, Yanagita H, Osada H, Shinbo M, Honda N. Evaluation of quality of life and psychological response in cancer patients treated with radiotherapy. Radiat Med. 2008 Aug;26(7):396-401. doi: 10.1007/s11604-008-0248-5. Epub 2008 Sep 4.
PMID: 18769996
citation: Johnson A, Sandford J. Written and verbal information versus verbal information only for patients being discharged from acute hospital settings to home: systematic review. Health Educ Res. 2005 Aug;20(4):423-9. doi: 10.1093/her/cyg141. Epub 2004 Nov 30.
PMID: 15572437
citation: Theis SL, Johnson JH. Strategies for teaching patients: a meta-analysis. Clin Nurse Spec. 1995 Mar;9(2):100-5, 120. doi: 10.1097/00002800-199503000-00010.
PMID: 7600475
citation: Friedman AJ, Cosby R, Boyko S, Hatton-Bauer J, Turnbull G. Effective teaching strategies and methods of delivery for patient education: a systematic review and practice guideline recommendations. J Cancer Educ. 2011 Mar;26(1):12-21. doi: 10.1007/s13187-010-0183-x.
PMID: 21161465
citation: Press Ganey: public reporting gives huge boost to patient satisfaction. Healthcare Benchmarks Qual Improv. 2008 Dec;15(12):121-3.
PMID: 19024286
citation: Meredith C, Symonds P, Webster L, Lamont D, Pyper E, Gillis CR, Fallowfield L. Information needs of cancer patients in west Scotland: cross sectional survey of patients' views. BMJ. 1996 Sep 21;313(7059):724-6. doi: 10.1136/bmj.313.7059.724.
PMID: 8819442
citation: Shaverdian N, Yeboa DN, Gardner L, Harari PM, Liao K, McCloskey S, Tuli R, Vapiwala N, Jagsi R. Nationwide Survey of Patients' Perspectives Regarding Their Radiation and Multidisciplinary Cancer Treatment Experiences. J Oncol Pract. 2019 Dec;15(12):e1010-e1017. doi: 10.1200/JOP.19.00376. Epub 2019 Nov 20.
PMID: 31747336
responsible party type: Sponsor
sharing ipd: No