NCT04141943

Brief Summary

The purpose of this study is to investigate the effect of providing information about radiotherapy using virtual reality and to see whether it would improve the productivity of medical staff, improve patient experience and satisfaction, and reduce patient's anxiety prior to radiotherapy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
196

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

October 21, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 28, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

March 13, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

November 18, 2020

Status Verified

November 1, 2020

Enrollment Period

1.6 years

First QC Date

October 21, 2019

Last Update Submit

November 16, 2020

Conditions

Keywords

Breast cancerradiotherapyvirtual reality

Outcome Measures

Primary Outcomes (2)

  • Amsterdam Preoperative Anxiety and Information Scale (APAIS)

    Changes in APAIS Before and After Providing Virtual Reality or Printed Document Information \- APAIS: scale from 1 (not worried at all) to 5 (extremely worried, most anxious)

    Prior to receiving the radiotherapy information via VR or printed document

  • Amsterdam Preoperative Anxiety and Information Scale (APAIS)

    Changes in APAIS Before and After Providing Virtual Reality or Printed Document Information \- APAIS: scale from 1 (not worried at all) to 5 (extremely worried, most anxious)

    5 minutes after receiving the radiotherapy information via VR or printed document

Secondary Outcomes (2)

  • State-Trait Anxiety Inventory (STAI)

    Prior to receiving the radiotherapy information via VR or printed document

  • State-Trait Anxiety Inventory (STAI)

    5 minutes after receiving the radiotherapy information via VR or printed document

Study Arms (2)

VR

EXPERIMENTAL

The patients who are allocated to the VR arm will receive information about radiotherapy via virtual reality

Other: Virtual reality

Printed document

NO INTERVENTION

The patients who are allocated to the Printed document arm will receive information about radiotherapy via printed document.

Interventions

The patients who are allocated to the VR arm will receive information about radiotherapy via virtual reality.

VR

Eligibility Criteria

Age20 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Breast cancer patients who received curative surgery and are planned to receive radiotherapy
  • Patients with cognitive abilities to receive virtual reality information
  • Patients who are 20 years old or older

You may not qualify if:

  • Patients who have vision or hearing problems to receive information
  • Patients who do not agree to this study
  • Pregnancy, Fetuses / Newborns, Minors, and Deficient Patients
  • years old or older
  • Patients who have been treated for dizziness within the last 6 months
  • Patients who have experienced severe dizziness within the last 6 months when using electronic devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, Korea, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Yong Bae Kim

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2019

First Posted

October 28, 2019

Study Start

March 13, 2020

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

November 18, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations