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

Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University (Other)
Overall Status
Terminated
CT.gov ID
NCT03318367
Collaborator
(none)
23
Enrollment
1
Arm
24.2
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Educational Intervention
 N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. 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:
  1. This pilot study could have implications for a broader patient base undergoing radiation therapy.

Study Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Pilot Study to Determine if the Use of a Virtual Reality Education Module Reduces Anxiety and Increases Comprehension in Patients Receiving Radiation Therapy
Actual Study Start Date :
Aug 6, 2014
Actual Primary Completion Date :
Jun 3, 2016
Actual Study Completion Date :
Aug 11, 2016

Arms and Interventions

Arm Intervention/Treatment
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
Complete virtual reality education module

Outcome Measures

Primary Outcome Measures

  1. Standard deviation for difference in questionnaire response from pre-education to post-education [Through study completion, an average of 2 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
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:

  • If inclusion criteria are not met

  • Previous radiation therapy treatment

  • Employment in radiation oncology

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

Investigators

  • Principal Investigator: Robert Den, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT03318367
Other Study ID Numbers:
  • 14D.354
First Posted:
Oct 23, 2017
Last Update Posted:
Oct 27, 2017
Last Verified:
Oct 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 27, 2017