Virtual Reality for Advanced Cancer Pain

NCT06534580 | Active Not Recruiting

• 1 other identifier: 158450
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

Brief 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. 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

1. 1.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.
2. 2.Develop and manualise a virtual reality intervention using co-design methodology.
3. 3.User-test the intervention to refine further.
4. 4.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.
5. 5.Guidelines for the use of virtual reality in a clinical setting.

Conditions

Neoplasm Metastasis; Pain; Palliative Care

Keywords

virtual reality; Pain management

Outcome Measures

Primary Outcomes (3)

• Data on the use of virtual reality for managing pain, from the perspective of people living with advanced cancer who experience pain.

  15 months

• A pilot of the intervention, how it will be implemented, and how it is expected to work.

  15 months

• A user-tested virtual reality intervention with a manual for use, including guidelines for use in clinical settings and research priorities

  15 months

Study Arms (3)

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.

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.

Device: Virtual Reality

Interventions

Virtual Reality DEVICE

A range of virtual reality software, delivered through the "DR.VR" (TM) device.

Phase I; Phase III

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

From in- and out- patient hospital and hospice settings where people are under specialist palliative care services.

You may qualify if:

• 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
• 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.

You may not qualify if:

• Patients will be excluded if:
• a diagnosis of epilepsy
• are imminently dying
• the clinical team feel it would be detrimental to participate
• 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.

Sponsors & Collaborators

• University College, London: lead
• Velindre NHS Trust: collaborator
• Lancaster University: collaborator
• Brighton and Sussex University Hospitals NHS Trust: collaborator

Study Sites (4)

Brighton and Sussex University Hospitals NHS Trust

Brighton, United Kingdom

Location

Velindre University NHS Trust

Cardiff, United Kingdom

Location

Marie Curie Hospice, Liverpool

Liverpool, United Kingdom

Location

St Christophers Hospice, London

London, United Kingdom

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Pain; Agnosia

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Nicola White, PhD

  University College, London

  PRINCIPAL INVESTIGATOR

• Ollie Minton

  Brighton and Sussex University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: September 1, 2024
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

GB (4)