Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534580
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Virtual Reality for Advanced Cancer Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Developing and Refining a Virtual Reality Intervention That Will Help to Manage Pain for People Living With Advanced Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VRcan
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 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 ifhow 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 eg a social media campaign leaflets to clinical settings blog and vlog posts
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 ifhow 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 eg a social media campaign leaflets to clinical settings blog and vlog posts
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None