AzTrials
AzTrials

Patient EducationNCT04469478

Virtual Reality in Imaging Review for Cancer Patients

A study testing Survey and interview in people with Patient Education and Virtual Reality, run by University of Colorado, Denver at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Survey and interview
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
15 Jul 2020to 30 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Inability to complete virtual reality, survey and interview.
  • Non-English speaking
  • Patients with visual defects that affect their ability to view content in VR

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Colorado, Anschutz Cancer Center

    Aurora, Colorado, 80015

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Survey and interview

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Survey and interviewOther

    Patients and caregivers will provide information via surveys and interviews regarding their experience viewing diagnostic imaging using conventional methods and using Virtual Reality

Study groups in NCT04469478
Study groupRoleWhat they receive
Virtual Reality for imaging reviewExperimentalEach 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
Receives: Other: Survey and interview

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Successful Completion of Imaging Review Using Virtual Reality

    The percentage of patients able to complete the review of their imaging using virtual reality

    Measured: During the consultation 1 day visit

Secondary outcomes (4)

  1. Satisfaction and preference

    Evaluate patients' and caregivers' satisfaction and preferences regarding diagnostic imaging review using a focused survey

    Measured: During the consultation 1 day visit

  2. Qualitative feedback regarding imaging review using virtual reality

    Collect patients' and caregivers' feedback regarding imaging review using virtual reality through qualitative interviews.

    Measured: During the consultation 1 day visit

  3. Baseline demographics and imaging review experience

    Capture baseline demographics, education, and prior experience with diagnostic imaging review.

    Measured: During the consultation 1 day visit

  4. Intervention time interval

    Measure the time spent reviewing diagnostic imaging with virtual reality and standard approaches relative to the consultation time

    Measured: During the consultation 1 day visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2020
  2. Study start15 Jul 2020
  3. Primary completion30 Jun 2021
  4. Study completion30 Jun 2021

Why it stopped: Study was not approved in 2020 secondary to COVID-19 restrictions on trials

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single Arm Exploratory Study
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04469478
Sponsor's protocol ID
20-0560.cc
Status last verified
Nov 2021
First submitted
9 Jul 2020
Last updated
9 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 1882153

  • 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.

    PubMed 16563940

  • 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.

    PubMed 24846702

  • 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.

    PubMed 18769996

  • 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.

    PubMed 15572437

  • 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.

    PubMed 7600475

  • 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.

    PubMed 21161465

  • Press Ganey: public reporting gives huge boost to patient satisfaction. Healthcare Benchmarks Qual Improv. 2008 Dec;15(12):121-3.

    PubMed 19024286

  • 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.

    PubMed 8819442

  • 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.

    PubMed 31747336

Questions about this trial

What is this clinical trial studying?

A study testing Survey and interview in people with Patient Education and Virtual Reality, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful Completion of Imaging Review Using Virtual Reality (time frame: During the consultation 1 day visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04469478, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.

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