Virtual Reality for Advanced Cancer Pain

Trial Title: Virtual Reality for Advanced Cancer Pain

NCT ID: NCT06534580

Condition: Neoplasm Metastasis
Pain
Palliative Care

Conditions: Official terms:
Neoplasm Metastasis

Conditions: Keywords:
virtual reality
Pain management

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Device
Intervention name: Virtual Reality
Description: A range of virtual reality software, delivered through the "DR.VR" (TM) device.
Arm group label: Phase I
Arm group label: Phase III

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. 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. Develop and manualise a virtual reality intervention using co-design methodology. 3. 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 1. 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. 2. 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.

Criteria for eligibility:

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

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: 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. Exclusion Criteria: 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: September 1, 2024

Completion date: November 30, 2025

Lead sponsor:
Agency: University College, London
Agency class: Other

Collaborator:
Agency: Velindre NHS Trust
Agency class: Other

Collaborator:
Agency: Lancaster University
Agency class: Other

Collaborator:
Agency: Brighton and Sussex University Hospitals NHS Trust
Agency class: Other

Source: University College, London

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06534580