- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04469478
Virtual Reality in Imaging Review for Cancer Patients
November 1, 2021 updated by: University of Colorado, Denver
The Use of Virtual Reality for Diagnostic Imaging Review With Cancer Patients
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.
Study Overview
Status
Withdrawn
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80015
- University of Colorado, Anschutz Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Willingness to sign and date the consent form.
- Willingness to comply with all study procedures and be available for the duration of the study.
- Male or female patient 18 years or older.
- Available diagnostic imaging (MRI, CT and/or PET)
- Consultation in radiation oncology for consideration of radiation therapy.
- English speaking.
Exclusion Criteria:
- Inability to complete virtual reality, survey and interview.
- Non-English speaking
- Patients with visual defects that affect their ability to view content in VR
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Reality for imaging review
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
|
Patients and caregivers will provide information via surveys and interviews regarding their experience viewing diagnostic imaging using conventional methods and using Virtual Reality
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Successful Completion of Imaging Review Using Virtual Reality
Time Frame: During the consultation 1 day visit
|
The percentage of patients able to complete the review of their imaging using virtual reality
|
During the consultation 1 day visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction and preference
Time Frame: During the consultation 1 day visit
|
Evaluate patients' and caregivers' satisfaction and preferences regarding diagnostic imaging review using a focused survey
|
During the consultation 1 day visit
|
|
Qualitative feedback regarding imaging review using virtual reality
Time Frame: During the consultation 1 day visit
|
Collect patients' and caregivers' feedback regarding imaging review using virtual reality through qualitative interviews.
|
During the consultation 1 day visit
|
|
Baseline demographics and imaging review experience
Time Frame: During the consultation 1 day visit
|
Capture baseline demographics, education, and prior experience with diagnostic imaging review.
|
During the consultation 1 day visit
|
|
Intervention time interval
Time Frame: During the consultation 1 day visit
|
Measure the time spent reviewing diagnostic imaging with virtual reality and standard approaches relative to the consultation time
|
During the consultation 1 day visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Press Ganey: public reporting gives huge boost to patient satisfaction. Healthcare Benchmarks Qual Improv. 2008 Dec;15(12):121-3.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2020
Primary Completion (Actual)
June 30, 2021
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
July 9, 2020
First Submitted That Met QC Criteria
July 13, 2020
First Posted (Actual)
July 14, 2020
Study Record Updates
Last Update Posted (Actual)
November 9, 2021
Last Update Submitted That Met QC Criteria
November 1, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 20-0560.cc
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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