OncologyNCT04821466
VR for Symptom Control and Wellbeing
A study testing Virtual Reality Headset to provide a Virtual Reality Experience in people with Oncology and End Stage Cancer, run by Royal Cornwall Hospitals Trust at 1 site in United Kingdom.
Trial summary
To investigate the effect that a Virtual Reality experience can have on patient symptoms and wellbeing for palliative care and oncology inpatients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology, End Stage Cancer, Palliative Care
- What is being tested?
- Virtual Reality Headset to provide a Virtual Reality Experience
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jun 2021to 20 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- <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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Virtual Reality for Symptom Control and Wellbeing in Palliative Care and Oncology Patients
To investigate the effect that a Virtual Reality experience can have on patient symptoms and wellbeing for palliative care and oncology inpatients
- Conditions
- Oncology, End Stage Cancer, Palliative Care, Hematologic Malignancy
- Being tested
- Virtual Reality Headset to provide a Virtual Reality Experience
- Keywords
- Virtual Reality
- Medical subject headings
- Neoplasms, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Headset to provide a Virtual Reality ExperienceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Headset | Experimental | VR headset, programmed with a selection of 7 wellbeing programs to identify if use will improve participants wellbeing Receives: Device: Virtual Reality Headset to provide a Virtual Reality Experience |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Time 0 & Time 60 minutes
Secondary outcomes (2)
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)
Measured: Time 60 minutes
Quantitative clinician experience of VR intervention
Patient score of experience using Virtual Reality intervention for symptoms and wellbeing between 0 (negative) and 10 (positive)
Measured: Time 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start14 Jun 2021
- Primary completion20 Sep 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cohort interrupted time series study
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Cornwall Hospitals Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Niall O Moon, BMBCh, Principal investigator, Doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821466
- Sponsor's protocol ID
- 2021.RCHT.07
- Status last verified
- Nov 2023
- First submitted
- 23 Mar 2021
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share patient data
Publications
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.
PubMed 39886490
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Virtual Reality for Symptom Control and Wellbeing in Palliative Care and Oncology Patients
- ClinicalTrials.gov ID
- NCT04821466
- Acronym / sponsor ID
- 2021.RCHT.07
- Conditions
- Oncology, End Stage Cancer, Palliative Care, Hematologic Malignancy
- Keywords
- Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Royal Cornwall Hospitals TrustUniversity, hospital or other
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effect that a Virtual Reality experience can have on patient symptoms and wellbeing for palliative care and oncology inpatients
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohort interrupted time series study
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Headset | Experimental | Device: Virtual Reality Headset to provide a Virtual Reality ExperienceVR headset, programmed with a selection of 7 wellbeing programs to identify if use will improve participants wellbeing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- > 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
Key exclusion criteria (5 listed)
- <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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Headset to provide a Virtual Reality ExperienceParticipants 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. | Device | Virtual Reality Headset |
Primary outcome
ESAS-r Quality of Life Scores
Time frame: Time 0 & Time 60 minutes
Change in ESAS-r QoL score between start and finish of Virtual Reality experience. 0 = No symptoms to 10 = Worst Symptom
2 secondary outcomes
Quantitative clinician experience of VR intervention
Time frame: Time 60 minutes
Quantitative clinician experience of VR intervention
Time frame: Time 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Derived from this study: PubMed 39886490Moon 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.
- Individual participant dataSharing planned: No. No plan to share patient data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niall O Moon, BMBCh principal investigator
Doctor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Headset to provide a Virtual Reality Experience in people with Oncology and End Stage Cancer, run by Royal Cornwall Hospitals Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ESAS-r Quality of Life Scores (time frame: Time 0 & Time 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04821466, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023; AzTrials last refreshed its copy on 28 Oct 2026.