NCT04821466

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

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

March 23, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

June 14, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2022

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

1.3 years

First QC Date

March 23, 2021

Last Update Submit

November 20, 2023

Conditions

Keywords

Virtual Reality

Outcome Measures

Primary Outcomes (1)

  • 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

    Time 0 & Time 60 minutes

Secondary Outcomes (2)

  • Quantitative clinician experience of VR intervention

    Time 60 minutes

  • Quantitative clinician experience of VR intervention

    Time 60 minutes

Other Outcomes (2)

  • Qualitative patient experience of VR interventions

    Time 60 minutes

  • Repeat VR experiences

    12 Months

Study Arms (1)

Virtual Reality Headset

EXPERIMENTAL

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

Device: Virtual Reality Headset to provide a Virtual Reality Experience

Interventions

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.

Virtual Reality Headset

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 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

You may not qualify if:

  • \<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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Cornwall Hospital

Truro, Cornwall, TR1 3HD, United Kingdom

Location

Related Publications (1)

  • Moon NO, Henstridge-Blows JR, Sprecher EA, Thomas E, Byfield A, McGrane J. 'Godrevy Project': virtual reality for symptom control and well-being in oncology and palliative care - a non-randomised pre-post interventional trial. BMJ Oncol. 2023 Dec 18;2(1):e000160. doi: 10.1136/bmjonc-2023-000160. eCollection 2023.

MeSH Terms

Conditions

NeoplasmsHematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Niall O Moon, BMBCh

    Doctor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Cohort interrupted time series study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2021

First Posted

March 29, 2021

Study Start

June 14, 2021

Primary Completion

September 20, 2022

Study Completion

September 20, 2022

Last Updated

November 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

No plan to share patient data

Locations