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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04469478
Other study ID # 20-0560.cc
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date July 15, 2020
Est. completion date June 30, 2021

Study information

Verified date November 2021
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
United States University of Colorado, Anschutz Cancer Center Aurora Colorado

Sponsors (2)

Lead Sponsor Collaborator
University of Colorado, Denver Colorado State University

Country where clinical trial is conducted

United States, 

References & Publications (10)

Fernsler JI, Cannon CA. The whys of patient education. Semin Oncol Nurs. 1991 May;7(2):79-86. — View 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. Review. — View 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. Review. — View 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. Review. — View 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. Epub 2004 Nov 30. Review. — View 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. — View Citation

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

Theis SL, Johnson JH. Strategies for teaching patients: a meta-analysis. Clin Nurse Spec. 1995 Mar;9(2):100-5, 120. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Successful Completion of Imaging Review Using Virtual Reality The percentage of patients able to complete the review of their imaging using virtual reality During the consultation 1 day visit
Secondary Satisfaction and preference Evaluate patients' and caregivers' satisfaction and preferences regarding diagnostic imaging review using a focused survey During the consultation 1 day visit
Secondary Qualitative feedback regarding imaging review using virtual reality Collect patients' and caregivers' feedback regarding imaging review using virtual reality through qualitative interviews. During the consultation 1 day visit
Secondary Baseline demographics and imaging review experience Capture baseline demographics, education, and prior experience with diagnostic imaging review. During the consultation 1 day visit
Secondary Intervention time interval Measure the time spent reviewing diagnostic imaging with virtual reality and standard approaches relative to the consultation time During the consultation 1 day visit
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