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VR for Symptom Control and Wellbeing

Primary Purpose

Oncology, End Stage Cancer, Palliative Care

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Virtual Reality Headset to provide a Virtual Reality Experience
Sponsored by
Royal Cornwall Hospitals Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oncology focused on measuring Virtual Reality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  • > 18 years of age
  • Inpatient at RCHT know to the palliative care team
  • Able to consent
  • Able to speak and understand the English language
  • Able to use the virtual reality system
  • Able to complete ESAS-r Questionnaire

Exclusion criteria

  • <18 years of age
  • Patient unable to consent
  • Patient unable to speak English
  • Unable to use the virtual reality system (e.g. visually impaired)
  • Known Epilepsy or seizures or suspected predisposition to seizures (e.g. Brain metastasis)

Sites / Locations

  • Royal Cornwall HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtual Reality Headset

Arm Description

VR headset, programmed with a selection of 7 wellbeing programs to identify if use will improve participants wellbeing

Outcomes

Primary Outcome Measures

ESAS-r Quality of Life Scores
Change in ESAS-r QoL score between start and finish of Virtual Reality experience. 0 = No symptoms to 10 = Worst Symptom

Secondary Outcome Measures

Quantitative clinician experience of VR intervention
Clinician score of patient experience using Virtual Reality intervention for symptoms and wellbeing between 0 (negative) and 10 (positive)
Quantitative clinician experience of VR intervention
Patient score of experience using Virtual Reality intervention for symptoms and wellbeing between 0 (negative) and 10 (positive)

Full Information

First Posted
March 23, 2021
Last Updated
July 29, 2022
Sponsor
Royal Cornwall Hospitals Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04821466
Brief Title
VR for Symptom Control and Wellbeing
Official Title
The Use of Virtual Reality for Symptom Control and Wellbeing in Palliative Care and Oncology Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2021 (Actual)
Primary Completion Date
April 4, 2023 (Anticipated)
Study Completion Date
April 4, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Cornwall Hospitals Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To investigate the effect that a Virtual Reality experience can have on patient symptoms and wellbeing for palliative care and oncology inpatients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oncology, End Stage Cancer, Palliative Care, Hematologic Malignancy
Keywords
Virtual Reality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Cohort interrupted time series study
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Headset
Arm Type
Experimental
Arm Description
VR headset, programmed with a selection of 7 wellbeing programs to identify if use will improve participants wellbeing
Intervention Type
Device
Intervention Name(s)
Virtual Reality Headset to provide a Virtual Reality Experience
Intervention Description
Participants will utilise a Virtual Reality experience for distraction therapy via a Virtual reality headset. Participants will wear the Virtual reality headset to be immersed in a multimedia experience.
Primary Outcome Measure Information:
Title
ESAS-r Quality of Life Scores
Description
Change in ESAS-r QoL score between start and finish of Virtual Reality experience. 0 = No symptoms to 10 = Worst Symptom
Time Frame
Time 0 & Time 60 minutes
Secondary Outcome Measure Information:
Title
Quantitative clinician experience of VR intervention
Description
Clinician score of patient experience using Virtual Reality intervention for symptoms and wellbeing between 0 (negative) and 10 (positive)
Time Frame
Time 60 minutes
Title
Quantitative clinician experience of VR intervention
Description
Patient score of experience using Virtual Reality intervention for symptoms and wellbeing between 0 (negative) and 10 (positive)
Time Frame
Time 60 minutes
Other Pre-specified Outcome Measures:
Title
Qualitative patient experience of VR interventions
Description
Patients to answer: Were there any negative side effects of the VR session?
Time Frame
Time 60 minutes
Title
Repeat VR experiences
Description
ESAS-r QoL Scores (0 to 10) will be collected each time a patient uses the experience to consider the effect repeat exposure has on wellbeing and symptoms. 0 = No symptoms to 10 = Worst Symptom
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria > 18 years of age Inpatient at RCHT know to the palliative care team Able to consent Able to speak and understand the English language Able to use the virtual reality system Able to complete ESAS-r Questionnaire Exclusion criteria <18 years of age Patient unable to consent Patient unable to speak English Unable to use the virtual reality system (e.g. visually impaired) Known Epilepsy or seizures or suspected predisposition to seizures (e.g. Brain metastasis)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Niall O Moon, BMBCh
Phone
01872 256347
Ext
6347
Email
niall.moon@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
John McGrane, MBChB
Phone
01872 256347
Ext
6347
Email
john.mcgrane@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niall O Moon, BMBCh
Organizational Affiliation
Doctor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Cornwall Hospital
City
Truro
State/Province
Cornwall
ZIP/Postal Code
TR1 3HD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nial Moon
First Name & Middle Initial & Last Name & Degree
John McGrane

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share patient data

Learn more about this trial

VR for Symptom Control and Wellbeing

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