NCT04469478

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

July 15, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

November 9, 2021

Status Verified

November 1, 2021

Enrollment Period

12 months

First QC Date

July 9, 2020

Last Update Submit

November 1, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Satisfaction and preference

    During the consultation 1 day visit

  • Qualitative feedback regarding imaging review using virtual reality

    During the consultation 1 day visit

  • Baseline demographics and imaging review experience

    During the consultation 1 day visit

  • Intervention time interval

    During the consultation 1 day visit

Study Arms (1)

Virtual Reality for imaging review

EXPERIMENTAL

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

Other: Survey and interview

Interventions

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

Virtual Reality for imaging review

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado, Anschutz Cancer Center

Aurora, Colorado, 80015, United States

Location

Related Publications (10)

  • 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: 1882153BACKGROUND
  • 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: 16563940BACKGROUND
  • 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: 24846702BACKGROUND
  • 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: 18769996BACKGROUND
  • 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: 15572437BACKGROUND
  • 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: 7600475BACKGROUND
  • 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: 21161465BACKGROUND
  • Press Ganey: public reporting gives huge boost to patient satisfaction. Healthcare Benchmarks Qual Improv. 2008 Dec;15(12):121-3.

    PMID: 19024286BACKGROUND
  • 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: 8819442BACKGROUND
  • 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: 31747336BACKGROUND

MeSH Terms

Interventions

Surveys and QuestionnairesInterviews as Topic

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single Arm Exploratory Study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2020

First Posted

July 14, 2020

Study Start

July 15, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

November 9, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations