Cancer and Non-cancer Hospice PatientsVRPCNCT05197894
Virtual Reality for Improving Symptoms in Palliative Care
A study testing Virtual Reality in people with Cancer and Non-cancer Hospice Patients, run by Western University, Canada at 1 site in Canada.
Trial summary
The objective of this study is to determine whether VR can ameliorate symptoms for palliative care patients within a hospice setting. We also aim to verify the efficacy with a larger sample size than previously shown, as well as extend the population to include non-cancer patients receiving Hospice care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer and Non-cancer Hospice Patients
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2023to 30 Jun 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 18 years or older
- admitted to Hospice for Specialty Palliative Care
Who cannot join
- Palliative Performance Scale (PPS) ≤ 20%
- severe cognitive impairment leading to inability to provide ESAS scores for 5 key symptoms measured in this study
- severe visual and/or hearing impairment preventing use of VR (glasses and hearing aids may be worn during VR sessions and do not exclude participation)
- absolute inability to sit
- paralysis of an upper limb
- participant dies before VR experience
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Hospice of Windsor and Essex County
Windsor, Ontario, N8T1B5
Patricia Valcke, 2898342486, pvalcke@thehospice.ca
Natan Veinberg, nveinberg2021@meds.uwo.ca
About this study
The objective of this study is to determine whether VR can ameliorate symptoms for palliative care patients within a hospice setting. We also aim to verify the efficacy with a larger sample size than previously shown, as well as extend the population to include non-cancer patients receiving Hospice care. We will further attempt to delineate whether there is a sustainability of symptomatic improvement one week after VR experiences.
Read the detailed description
Potential candidates will be provided with our assent and consent information form and the study will be explained to them in detail prior to gaining consent. As per standard practice at The Hospice of Windsor \& Essex County, palliative care ESAS symptoms will be measured at baseline during the week prior to the VR experience. The mean of these pre-VR scores will be calculated as a baseline, optimally 3 separate ESAS scores in the preceding week. ESAS symptoms and expectations/satisfaction will then be measured immediately before and after the VR experience. An average set of ESAS scores will then be calculated in the same manner for one week post VR as per baseline pre-VR scores above.
We expect to find a decrease in Palliative Care symptoms after the intervention of a VR experience.
- Conditions
- Cancer and Non-cancer Hospice Patients
- Being tested
- Virtual Reality
- Keywords
- virtual reality, palliative care, Edmonton symptom assessment scale, Hospice, depression, anxiety, pain, shortness of breath, well-being
- Medical subject headings
- Neoplasms, Depression, Anxiety Disorders, Pain, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
The intervention is a Virtual Reality experience within a selected application using an Oculus Quest 2 ©, as previously in the relevant intervention arm.
| Study group | Role | What they receive |
|---|---|---|
| VR experience | Experimental | Participants will be given a list of VR applications to choose from. They will then be given instructions by a research assistant (approximately 10 minutes) on how to use the selected application they have chosen, as well as time for any questions they may have before starting their VR experience. They will then have an approximately 30-minute session of that VR experience. They may or may not be accompanied by a family member or significant other and will also have a research assistant available to aid them in any difficulties experienced during the VR experience. Receives: Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
VR experience effect on pain, shortness of breath, depression, anxiety, and well-being scores (0 - 10)
The primary outcome of this study will be a significant difference in change of ESAS score for 5 key symptoms (pain, shortness of breath, depression, anxiety, and well-being) immediately before and after a VR experience.
Measured: ESAS scores measured immediately before VR experience will be compared to ESAS scores measured immediately after VR experience
Secondary outcomes (4)
VR experience longitudinal effect (one week later) on baseline pain, shortness of breath, depression, anxiety, and well-being scores (0 - 10)
The first secondary outcome of this study will be a significant difference between the mean of the 1-week pre-VR and the mean of the 1-week post-VR ESAS scores for 5 key symptoms (pain, shortness of breath, depression, anxiety, and well-being). For more objective evaluation of pain and distress we will also be measuring vitals immediately before and immediately after each VR experience.
Measured: Baseline average ESAS scores measured one week prior to the VR experience will be compared to the average of ESAS scores one week following the VR experience.
VR experience effect on Mean Arterial Pressure (MAP) (part of vital signs) as indicator for Pain and/or Distress
For more objective evaluation of pain and distress, the investigators will be measuring blood pressure to compare the Mean Arterial Pressure (MAP; mmHg) immediately before and immediately after each VR experience.
Measured: MAP measured immediately before and immediately after each VR experience.
VR experience effect on Heart Rate (HR) (part of vital signs) as indicator for Pain and/or Distress
For more objective evaluation of pain and distress, the investigators will be measuring Heart Rate (HR; beats per minute [bpm]) immediately before and immediately after each VR experience.
Measured: HR measured immediately before and immediately after each VR experience.
VR experience effect on Respiratory Rate (RR) (part of vital signs) as indicator for Pain and/or Distress
For more objective evaluation of pain and distress, the investigators will be measuring Respiratory Rate (RR; breaths per minute [brpm]) immediately before and immediately after each VR experience.
Measured: RR measured immediately before and immediately after each VR experience.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Aug 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer and Non-cancer Hospice PatientsStudies 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
- ESAS scores for 5 key symptoms (pain, shortness of breath, depression, anxiety, and well-being) and qualitative question(s) will be asked verbally by one of the investigators and recorded on an ipad directly into the Qualtrics form, before and after the VR session. Vital signs (blood pressure, heart rate, respiratory rate) will also be measured before and after the VR session. Participants will be given a list of VR applications to choose from. They will then be given instructions by a research assistant (approximately 10 minutes) on how to use the selected application using Oculus Quest 2 they have chosen, as well as time for any questions they may have before starting their VR experience. They will then have an approximately 30-minute session of that VR experience. They may or may not be accompanied by a family member or significant other and will also have a research assistant available to aid them in any difficulties experienced during the VR experience.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Valcke, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197894
- Sponsor's protocol ID
- Windsor Essex Hospice VR
- Acronym
- VRPC
- Status last verified
- May 2024
- First submitted
- 19 Nov 2021
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently, there is no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality for Improving Symptoms in Palliative Care
- ClinicalTrials.gov ID
- NCT05197894
- Acronym / sponsor ID
- VRPC / Windsor Essex Hospice VR
- Conditions
- Cancer and Non-cancer Hospice Patients
- Keywords
- virtual reality, palliative care, Edmonton symptom assessment scale, Hospice, depression, anxiety, pain, shortness of breath
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 20 Jan 2022 (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.
The objective of this study is to determine whether VR can ameliorate symptoms for palliative care patients within a hospice setting. We also aim to verify the efficacy with a larger sample size than previously shown, as well as extend the population to include non-cancer patients receiving Hospice care. We will further attempt to delineate whether there is a sustainability of symptomatic improvement one week after VR experiences.
Detailed description
Potential candidates will be provided with our assent and consent information form and the study will be explained to them in detail prior to gaining consent. As per standard practice at The Hospice of Windsor \& Essex County, palliative care ESAS symptoms will be measured at baseline during the week prior to the VR experience. The mean of these pre-VR scores will be calculated as a baseline, optimally 3 separate ESAS scores in the preceding week. ESAS symptoms and expectations/satisfaction will then be measured immediately before and after the VR experience. An average set of ESAS scores will then be calculated in the same manner for one week post VR as per baseline pre-VR scores above.
We expect to find a decrease in Palliative Care symptoms after the intervention of a VR experience.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- ESAS scores for 5 key symptoms (pain, shortness of breath, depression, anxiety, and well-being) and qualitative question(s) will be asked verbally by one of the investigators and recorded on an ipad directly into the Qualtrics form, before and after the VR session. Vital signs (blood pressure, heart rate, respiratory rate) will also be measured before and after the VR session. Participants will be given a list of VR applications to choose from. They will then be given instructions by a research assistant (approximately 10 minutes) on how to use the selected application using Oculus Quest 2 they have chosen, as well as time for any questions they may have before starting their VR experience. They will then have an approximately 30-minute session of that VR experience. They may or may not be accompanied by a family member or significant other and will also have a research assistant available to aid them in any difficulties experienced during the VR experience.
| Arm | Type | Receives |
|---|---|---|
| VR experience | Experimental | Device: Virtual RealityParticipants will be given a list of VR applications to choose from. They will then be given instructions by a research assistant (approximately 10 minutes) on how to use the selected application they have chosen, as well as time for any questions they may have before starting their VR experience. They will then have an approximately 30-minute session of that VR experience. They may or may not be accompanied by a family member or significant other and will also have a research assistant available to aid them in any difficulties experienced during the VR experience. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least 18 years or older
- admitted to Hospice for Specialty Palliative Care
Key exclusion criteria (6 listed)
- Palliative Performance Scale (PPS) ≤ 20%
- severe cognitive impairment leading to inability to provide ESAS scores for 5 key symptoms measured in this study
- severe visual and/or hearing impairment preventing use of VR (glasses and hearing aids may be worn during VR sessions and do not exclude participation)
- absolute inability to sit
- paralysis of an upper limb
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 RealityThe intervention is a Virtual Reality experience within a selected application using an Oculus Quest 2 ©, as previously in the relevant intervention arm. | Device | VR experience |
Primary outcome
VR experience effect on pain, shortness of breath, depression, anxiety, and well-being scores (0 - 10)
Time frame: ESAS scores measured immediately before VR experience will be compared to ESAS scores measured immediately after VR experience
The primary outcome of this study will be a significant difference in change of ESAS score for 5 key symptoms (pain, shortness of breath, depression, anxiety, and well-being) immediately before and after a VR experience.
4 secondary outcomes
VR experience longitudinal effect (one week later) on baseline pain, shortness of breath, depression, anxiety, and well-being scores (0 - 10)
Time frame: Baseline average ESAS scores measured one week prior to the VR experience will be compared to the average of ESAS scores one week following the VR experience.
VR experience effect on Mean Arterial Pressure (MAP) (part of vital signs) as indicator for Pain and/or Distress
Time frame: MAP measured immediately before and immediately after each VR experience.
VR experience effect on Heart Rate (HR) (part of vital signs) as indicator for Pain and/or Distress
Time frame: HR measured immediately before and immediately after each VR experience.
VR experience effect on Respiratory Rate (RR) (part of vital signs) as indicator for Pain and/or Distress
Time frame: RR measured immediately before and immediately after each VR experience.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: No. Currently, there is no plan to make individual participant data (IPD) available to other researchers.
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.
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 in people with Cancer and Non-cancer Hospice Patients, run by Western University, Canada at 1 site in Canada.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 7 May 2024. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia Valcke, MD ((519) 974-7100, pvalcke@thehospice.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VR experience effect on pain, shortness of breath, depression, anxiety, and well-being scores (0 - 10) (time frame: ESAS scores measured immediately before VR experience will be compared to ESAS scores measured immediately after VR experience). 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 7 May 2024.