Neoplasm MetastasisVRcanNCT06534580
Virtual Reality for Advanced Cancer Pain
An observational study of Neoplasm Metastasis and Pain, run by University College, London at 4 sites in United Kingdom.
Trial summary
Background Pain is commonly experienced by people who are living with advanced (incurable) cancer. There is evidence to suggest virtual reality could help to relieve this pain: however, this evidence is poor quality with the intervention poorly defined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Metastasis, Pain, Palliative Care
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 1 Sep 2024to 30 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: From in- and out- patient hospital and hospice settings where people are under specialist palliative care services.
Who may be able to join
- Patients will be considered eligible to participate if:
- Under the care of the specialist palliative care team or cancer centre
- A documented diagnosis of advanced cancer (Synonyms: "Palliative", "terminal", "incurable", "treatable but not curable") in their medical notes, confirmed by the clinical team.
- Adult (aged 18 years or over)
- Pain score in the last 7 days of ≥1 on Numerical Rating Scale [0-10]
- Full visual and auditory abilities
Show all 13Show fewer
- No restriction in range of head and neck movement
- Capacity to consent to the study
- Fluent in English
- An estimated prognosis of longer than 6 months.
- Professional/staff participants will be considered eligible if:
- a registered healthcare professional (doctors, nurses, allied health professionals, psychologists)
- employed by the study or location or by the virtual reality company.
Who cannot join
- Patients will be excluded if:
- a diagnosis of epilepsy
- are imminently dying
- the clinical team feel it would be detrimental to participate
- do not meet the study inclusion criteria
- Professional/staff participants will be excluded if:
- They are not employed by the study location, or the virtual reality company
- We will document reasons for not participating, where offered.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Brighton and Sussex University Hospitals NHS Trust
Brighton
Velindre University NHS Trust
Cardiff
Marie Curie Hospice, Liverpool
Liverpool
St Christophers Hospice, London
London
About this study
Official title: Developing and Refining a Virtual Reality Intervention That Will Help to Manage Pain for People Living With Advanced Cancer
Background
Pain is commonly experienced by people who are living with advanced (incurable) cancer. There is evidence to suggest virtual reality could help to relieve this pain: however, this evidence is poor quality with the intervention poorly defined. A robustly co-designed intervention, with people who have advanced cancer and experience pain, will facilitate a better evidence-base.
Read more
Aim
To develop and refine a virtual reality intervention that will help people living with advanced cancer to manage pain.
Objectives
- Explore and establish key components of a virtual reality intervention for people with advanced cancer in terms of effectiveness, acceptability and feasibility using in-depth interviews and focus groups with people living with advanced cancer and experiencing pain.
- Develop and manualise a virtual reality intervention using co-design methodology.
- User-test the intervention to refine further.
Methods
Multi-method design, incorporating multiple stakeholder perspectives, over three phases:
Phase I. Focus groups or individual interviews with a total of 40 people, from four locations (Brighton, Cardiff, Liverpool, \& London), who have advanced cancer and experience pain.
They will use the virtual reality intervention and give feedback on what resonated with them and what they would change.
Phase II. Four focus groups (one at each study location) with multiple stakeholders. During this stage, the findings from phase 1 will be presented and a manual will be produced that gives guidelines on use of the virtual reality intervention.
Phase III. Up to 20 people living with advanced cancer and pain will user-test the intervention over an eight-week period. During this phase, the investigators will test if/how often the virtual reality is used as part of routine practice in each site and identify any barriers of use.
Anticipated Impact and Dissemination
- A robustly co-designed intervention, ready for testing in a larger trial, to assess the clinical and cost effectiveness of virtual reality as a form of pain management.
- Guidelines for the use of virtual reality in a clinical setting.
The results will be published through academic routes (peer-reviewed publications as well as presented at national and international conferences). The investigators will also work with our group of people with lived experience and an oversight committee to establish the best other routes to disseminate the findings to the public e.g., a social media campaign, leaflets to clinical settings, blog and vlog posts.
- Conditions
- Neoplasm Metastasis, Pain, Palliative Care
- Being tested
- Virtual Reality
- Keywords
- virtual reality, Pain management
- Medical subject headings
- Neoplasm Metastasis, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
A range of virtual reality software, delivered through the "DR.VR" (TM) device.
| Study group | Role | What they receive |
|---|---|---|
| Phase I | People living with advanced cancer and experiencing pain.
Participants will complete two interviews. In each interview, they will use a Virtual Reality headset and discuss with the researcher the potential benefits, any changes they would make to the experiences, and how they might use it in practice. Receives: Device: Virtual Reality | |
| Phase II | Participants: Staff working at participating sites, technology specialists, Patient and Public Involvement (PPI) representative. There will be a workshop at each participating site. Participants will work together to manualise the intervention so that it is ready for a feasibility trial and process evaluation. They will discuss the following: * Indications of use for virtual reality as a pain therapy * Frequency of use: recommended number of sessions, duration. * Barriers or facilitators that might impact the use of virtual reality. * Pain and other patient-reported outcomes identified. * What possible longer-term goals of using virtual reality as a pain therapy could include. * Guidance for specific settings, including safety considerations. * Operator instructions: patient or operator delivered. * Infection control management. | |
| Phase III | Participants: People living with advanced cancer and experiencing pain.
During this phase, we will implement the recommendations from the manual from phase II. A headset will be available for use on an as needed basis at each study location. Participants will be asked to provide feedback each time they use the headset. Specific for data on pain, the Brief Pain Inventory (BPI) will be completed. This looks at pain severity as well as how much pain impacts their daily life. Whilst the availability of only one headset per site will limit the frequency of use, particularly for those who are outpatients, this is reflective of current availability of virtual reality headsets in each location. This data will generate recommendations for future research and clinical practice, including the consideration of the economic impact. Receives: Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data on the use of virtual reality for managing pain, from the perspective of people living with advanced cancer who experience pain.
Measured: 15 months
A pilot of the intervention, how it will be implemented, and how it is expected to work.
Measured: 15 months
A user-tested virtual reality intervention with a manual for use, including guidelines for use in clinical settings and research priorities
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Sep 2024
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm MetastasisStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Velindre NHS Trust, Lancaster University, Brighton and Sussex University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Nicola White, PhD, Principal investigator, University College, LondonOllie Minton, Principal investigator, Brighton and Sussex University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534580
- Sponsor's protocol ID
- 158450
- Acronym
- VRcan
- Status last verified
- Dec 2024
- First submitted
- 30 Jul 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Refining a Virtual Reality Intervention That Will Help to Manage Pain for People Living With Advanced Cancer
- ClinicalTrials.gov ID
- NCT06534580
- Acronym / sponsor ID
- VRcan / 158450
- Conditions
- Neoplasm Metastasis, Pain, Palliative Care
- Keywords
- virtual reality, Pain management
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Velindre NHS Trust, Lancaster University, Brighton and Sussex University Hospitals NHS Trust
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 2 Aug 2024 (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.
Background
Pain is commonly experienced by people who are living with advanced (incurable) cancer. There is evidence to suggest virtual reality could help to relieve this pain: however, this evidence is poor quality with the intervention poorly defined. A robustly co-designed intervention, with people who have advanced cancer and experience pain, will facilitate a better evidence-base.
Aim
To develop and refine a virtual reality intervention that will help people living with advanced cancer to manage pain.
Objectives
- Explore and establish key components of a virtual reality intervention for people with advanced cancer in terms of effectiveness, acceptability and feasibility using in-depth interviews and focus groups with people living with advanced cancer and experiencing pain.
- Develop and manualise a virtual reality intervention using co-design methodology.
- User-test the intervention to refine further.
Methods
Multi-method design, incorporating multiple stakeholder perspectives, over three phases:
Phase I. Focus groups or individual interviews with a total of 40 people, from four locations (Brighton, Cardiff, Liverpool, \& London), who have advanced cancer and experience pain.
They will use the virtual reality intervention and give feedback on what resonated with them and what they would change.
Phase II. Four focus groups (one at each study location) with multiple stakeholders. During this stage, the findings from phase 1 will be presented and a manual will be produced that gives guidelines on use of the virtual reality intervention.
Phase III. Up to 20 people living with advanced cancer and pain will user-test the intervention over an eight-week period. During this phase, the investigators will test if/how often the virtual reality is used as part of routine practice in each site and identify any barriers of use.
Anticipated Impact and Dissemination
- A robustly co-designed intervention, ready for testing in a larger trial, to assess the clinical and cost effectiveness of virtual reality as a form of pain management.
- Guidelines for the use of virtual reality in a clinical setting.
The results will be published through academic routes (peer-reviewed publications as well as presented at national and international conferences). The investigators will also work with our group of people with lived experience and an oversight committee to establish the best other routes to disseminate the findings to the public e.g., a social media campaign, leaflets to clinical settings, blog and vlog posts.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase I | – | Device: Virtual RealityPeople living with advanced cancer and experiencing pain. Participants will complete two interviews. In each interview, they will use a Virtual Reality headset and discuss with the researcher the potential benefits, any changes they would make to the experiences, and how they might use it in practice. |
| Phase II | – | –Participants: Staff working at participating sites, technology specialists, Patient and Public Involvement (PPI) representative. There will be a workshop at each participating site. Participants will work together to manualise the intervention so that it is ready for a feasibility trial and process evaluation. They will discuss the following: * Indications of use for virtual reality as a pain therapy * Frequency of use: recommended number of sessions, duration. * Barriers or facilitators that might impact the use of virtual reality. * Pain and other patient-reported outcomes identified. * What possible longer-term goals of using virtual reality as a pain therapy could include. * Guidance for specific settings, including safety considerations. * Operator instructions: patient or operator delivered. * Infection control management. |
| Phase III | – | Device: Virtual RealityParticipants: People living with advanced cancer and experiencing pain. During this phase, we will implement the recommendations from the manual from phase II. A headset will be available for use on an as needed basis at each study location. Participants will be asked to provide feedback each time they use the headset. Specific for data on pain, the Brief Pain Inventory (BPI) will be completed. This looks at pain severity as well as how much pain impacts their daily life. Whilst the availability of only one headset per site will limit the frequency of use, particularly for those who are outpatients, this is reflective of current availability of virtual reality headsets in each location. This data will generate recommendations for future research and clinical practice, including the consideration of the economic impact. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From in- and out- patient hospital and hospice settings where people are under specialist palliative care services.
Key inclusion criteria (13 listed)
- Under the care of the specialist palliative care team or cancer centre
- A documented diagnosis of advanced cancer (Synonyms: "Palliative", "terminal", "incurable", "treatable but not curable") in their medical notes, confirmed by the clinical team.
- Adult (aged 18 years or over)
- Pain score in the last 7 days of ≥1 on Numerical Rating Scale [0-10]
- Full visual and auditory abilities
Key exclusion criteria (8 listed)
- a diagnosis of epilepsy
- are imminently dying
- the clinical team feel it would be detrimental to participate
- do not meet the study inclusion criteria
- They are not employed by the study location, or the virtual reality company
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 RealityA range of virtual reality software, delivered through the "DR.VR" (TM) device. | Device | Phase I, Phase III |
Primary outcome
Data on the use of virtual reality for managing pain, from the perspective of people living with advanced cancer who experience pain.
Time frame: 15 months
A pilot of the intervention, how it will be implemented, and how it is expected to work.
Time frame: 15 months
A user-tested virtual reality intervention with a manual for use, including guidelines for use in clinical settings and research priorities
Time frame: 15 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Nicola White, PhD principal investigator
University College, London
Ollie Minton principal investigator
Brighton and Sussex University Hospitals NHS Trust
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasm Metastasis and Pain, run by University College, London at 4 sites 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 13 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Data on the use of virtual reality for managing pain, from the perspective of people living with advanced cancer who experience pain. (time frame: 15 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2024.