NCT03318367

Brief 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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Status
terminated

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

Study Start

First participant enrolled

August 6, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 23, 2017

Completed
Last Updated

May 2, 2025

Status Verified

May 1, 2025

Enrollment Period

1.8 years

First QC Date

June 22, 2017

Last Update Submit

May 1, 2025

Conditions

Prostate

Outcome Measures

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.

    Through study completion, an average of 2 years

Study Arms (1)

Supportive care (virtual reality education module)

EXPERIMENTAL

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

Educational InterventionOTHER

Complete virtual reality education module

Supportive care (virtual reality education module)

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Previous radiation therapy treatment
  • Employment in radiation oncology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Robert Den, MD

    Sidney Kimmel Cancer Center at Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2017

First Posted

October 23, 2017

Study Start

August 6, 2014

Primary Completion

June 3, 2016

Study Completion

August 11, 2016

Last Updated

May 2, 2025

Record last verified: 2025-05