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TerminatedNCT03318367Updated May 2, 2025

Virtual Reality Education Module in Reducing Anxiety and Increasing Knowledge in Patients With Prostate Cancer Undergoing Radiation Therapy

An interventional study of Educational Intervention in Prostate, sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University. Terminated. Open to male participants. Per ClinicalTrials.gov, last updated 2025-05-02.

Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University · Not applicable, Interventional, and Supportive care

Why this study was terminated
The study expired at the IRB
Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Sex
Male
01

Study summary

This pilot clinical trial studies a virtual reality education module in reducing anxiety and increasing knowledge in patients with prostate cancer undergoing radiation therapy. A virtual reality education module may be useful in helping patients understand what they can expect to happen during their radiation treatments and help reduce stress relating to the radiation treatments.

Read the detailed description

PRIMARY OBJECTIVES:

I. To determine if a virtual reality education module for prostate cancer patients is effective in increasing patient comprehension and decreasing patient anxiety related to radiation treatments.

SECONDARY OBJECTIVES:

I. This pilot study could have implications for a broader patient base undergoing radiation therapy.

02

Conditions studied

  • Prostate
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • English speaking males capable of giving informed consent
  • Must be able to read English language
  • Receiving pre-treatment cone beam and volumetric modulated arc therapy (VMAT) for prostate cancer on the "A" or "B" treatment machines at the Bodine Center
  • Must be able to walk two city blocks
  • Must not have any auditory or visual deficits

Exclusion criteria

Exclusion Criteria:

  • If inclusion criteria are not met
  • Previous radiation therapy treatment
  • Employment in radiation oncology
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    Supportive care (virtual reality education module)

    After undergoing a previously planned CT simulation scan, patients complete a virtual reality education module to learn more about radiation therapy for prostate cancer. Patients also complete questionnaires before and after the module.

    Other: Educational Intervention

Interventions

  • OtherEducational Intervention

    Complete virtual reality education module

05

What researchers measure

Primary outcomes

  1. Standard deviation for difference in questionnaire response from pre-education to post-education

    A one-sided one-sample t-test will be used to analyze the average change score (pre - post) for each questionnaire.

    Time frame: Through study completion, an average of 2 years

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03318367
Lead sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Responsible party
Sponsor
First posted
Oct 23, 2017
Start date
Aug 6, 2014
Primary completion
Jun 3, 2016
Completion
Aug 11, 2016
Last update
May 2, 2025

Study contacts

Robert Den, MD
principal investigator · Sidney Kimmel Cancer Center at Thomas Jefferson University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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