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Virtual Reality Therapy to Improve Physical and Psychological Symptoms and Quality of Life for End-of-life Patients on a Palliative Care Unit

Primary Purpose

End-of-Life, Physical Suffering, Psychological Distress

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Standardized Virtual Reality
Control
Personalized Virtual Reality
Sponsored by
Baycrest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for End-of-Life focused on measuring Palliative Care, Symptom management, Virtual Reality

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Admitted to Baycrest PCU
  • Capable to consent to the study
  • Able to complete the outcome measures through a telephone interview with a research assistant
  • Estimated prognosis ≥3 weeks
  • At least 2 or more ESAS scores of 4 or greater within the week of the intervention
  • English speaking

Exclusion Criteria:

  • Intractable nausea/vomiting
  • History of seizures or epilepsy
  • Vision and/or hearing impairment that cannot be accommodated e.g. pocket talker
  • Any abnormalities of the head preventing use of the headset
  • Patients who are too unwell to participate based on the opinion of the clinical team

Sites / Locations

  • Baycrest Health SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Standardized Virtual Reality

Personalized Virtual Reality

Two-Dimensional Video

Arm Description

Participants in the standard virtual reality (VR) group will choose from the general library of VR experiences. Participants will be asked to select an experience they desire but have never experienced in person. The session will be facilitated by the therapeutic recreation staff on the unit.

There are two types of personalized VR: 1) Family/friends provide personalized content (e.g., life stories, photos, videos) that will be used during the VR session. Family/friends of participants in the personalized VR group will have the opportunity to upload custom photos, videos, life stories or capture their own 360° footage of family events using a GoPro camera that will be loaned to them for the study. This content will be uploaded to a cloud-based portal. 2) If the family/friends of those in the personalized VR arm are unavailable/unable/unwilling to provide personalized content the participant will select a video from the VR library of an experience that is personally memorable to them, such as their childhood hometown, a favourite vacation destination. The session will be facilitated by the therapeutic recreation staff on the unit.

Participants in the active comparator group will choose a two-dimensional video such as a mountain view, ocean view or safari. Participants will view the two-dimensional video on an iPad and the session will be facilitated by the therapeutic recreation staff on the unit.

Outcomes

Primary Outcome Measures

Change in Edmonton Symptom Assessment Scale (ESAS) Score
The ESAS is a self-report measure used to assist in the assessment of pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing, and shortness of breath (Bruera, Kuehn, Miller, Selmser, & Macmillan, 1991). The severity of the symptom at the time of the assessment is rated from zero to ten, with zero meaning the symptom is absent and ten meaning worst possible severity. For the purpose of the study the ESAS was modified to include two additional items, headache and dizziness. Analysis of the ESAS scores across the different time points will help determine whether VR effects are transient (within 24 hours) or sustained (after 2 and 7 days).
Change in Missoula-VITAS Quality of Life Index (MVQOLI)
The MVQOLI evaluates subjective quality of life among people living with advanced, life-threatening illness by assessing the domains of symptoms, function, interpersonal, wellbeing, and transcendence (Schwartz, Merriman, Reed, & Byock, 2005). Each domain includes three Likert-scale evaluation questions. Analysis of the MVQOLI scores across the different time points will help determine whether VR effects are transient (within 24 hours) or sustained (after 2 and 7 days).

Secondary Outcome Measures

Full Information

First Posted
June 29, 2021
Last Updated
July 5, 2021
Sponsor
Baycrest
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1. Study Identification

Unique Protocol Identification Number
NCT04966260
Brief Title
Virtual Reality Therapy to Improve Physical and Psychological Symptoms and Quality of Life for End-of-life Patients on a Palliative Care Unit
Official Title
Virtual Reality Therapy to Improve Physical and Psychological Symptoms and Quality of Life for End-of-life Patients on a Palliative Care Unit: a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2021 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baycrest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
People with advanced and life-threatening illnesses experience challenges across multiple domains of function including physical, psychological, social, and spiritual. The benefits of non-pharmacological interventions for palliative care patients are well recognized, but are relatively under-utilized. Virtual Reality (VR) therapy may help address these challenges and be a valuable addition to the current therapies used in palliative care. VR is a computer generated, three-dimensional environment that individuals can explore and interact with using specialized equipment such as a head-mounted display with internal sensors. VR has been increasingly adapted for applications in healthcare, as a simulation for medical training and an intervention tool to impact pain management, stress and anxiety. VR has the potential to improve both physical and psychological symptoms in patients with terminal illnesses. The current study is a small randomized controlled trial to understand the impact of VR on physical symptoms, psychological symptoms and quality of life in patients at the end of life. Participants will be randomized to a single comparator session, single session of standard VR, or single session of personalized VR. The comparator arm will consist of participants viewing an ordinary two-dimensional video on an iPad such as a peaceful nature scene. The standard VR arm will consist of participants viewing a "bucket list" experience self-selected from a VR library i.e. an experience the participant desires but has never experienced. The personalized VR arm will consist of participants viewing content that is personally meaningful to them. This content will be obtained through either a) family/friends creating a personalized video (e.g. video footage of their summer cottage) or b) the participant will select an experience from the VR library that is personally meaningful (e.g. visiting their honeymoon destination, exploring their childhood hometown, etc.) if option a) is not possible. Participants will complete self-report questionnaires about their physical and psychological symptoms and quality of life before and after the intervention (two days and seven days post intervention). Participants will also complete a feedback survey to evaluate their satisfaction with the intervention. Surveys will be administered by the research assistant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-of-Life, Physical Suffering, Psychological Distress
Keywords
Palliative Care, Symptom management, Virtual Reality

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a small randomized controlled trial conducted in a study population of patients admitted to a geriatric palliative care unit. The clinical team will determine if the patient is eligible for the study. Patients and families/friends of patients who are randomized to the personalized VR will be consented over the telephone by the research assistant., Participants will then be randomly assigned into one of the three study arms: comparator, standardized VR or personalized VR, on a 1:1:1 basis using computer-generated random numbers and a block size of 3 without additional stratification.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standardized Virtual Reality
Arm Type
Experimental
Arm Description
Participants in the standard virtual reality (VR) group will choose from the general library of VR experiences. Participants will be asked to select an experience they desire but have never experienced in person. The session will be facilitated by the therapeutic recreation staff on the unit.
Arm Title
Personalized Virtual Reality
Arm Type
Experimental
Arm Description
There are two types of personalized VR: 1) Family/friends provide personalized content (e.g., life stories, photos, videos) that will be used during the VR session. Family/friends of participants in the personalized VR group will have the opportunity to upload custom photos, videos, life stories or capture their own 360° footage of family events using a GoPro camera that will be loaned to them for the study. This content will be uploaded to a cloud-based portal. 2) If the family/friends of those in the personalized VR arm are unavailable/unable/unwilling to provide personalized content the participant will select a video from the VR library of an experience that is personally memorable to them, such as their childhood hometown, a favourite vacation destination. The session will be facilitated by the therapeutic recreation staff on the unit.
Arm Title
Two-Dimensional Video
Arm Type
Active Comparator
Arm Description
Participants in the active comparator group will choose a two-dimensional video such as a mountain view, ocean view or safari. Participants will view the two-dimensional video on an iPad and the session will be facilitated by the therapeutic recreation staff on the unit.
Intervention Type
Other
Intervention Name(s)
Standardized Virtual Reality
Intervention Description
This is a one session intervention, where participants will be asked to wear a VR headset and view a three-dimensional standard VR video. The activity session will be approximately 15 minutes in length. Prior to starting the intervention, the therapeutic recreation staff will explain the activity and familiarize participants with the VR headset.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
This is a one session intervention, where participants will be asked to view a two-dimensional video on an iPad. The activity session will be approximately 15 minutes in length. Prior to starting the activity session, the therapeutic recreation staff will explain the activity.
Intervention Type
Other
Intervention Name(s)
Personalized Virtual Reality
Intervention Description
This is a one session intervention, where participants will be asked to wear a VR headset and view a three-dimensional personalized VR video. The activity session will be approximately 15 minutes in length. Prior to starting the intervention, the therapeutic recreation staff will explain the activity and familiarize participants with the VR headset.
Primary Outcome Measure Information:
Title
Change in Edmonton Symptom Assessment Scale (ESAS) Score
Description
The ESAS is a self-report measure used to assist in the assessment of pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing, and shortness of breath (Bruera, Kuehn, Miller, Selmser, & Macmillan, 1991). The severity of the symptom at the time of the assessment is rated from zero to ten, with zero meaning the symptom is absent and ten meaning worst possible severity. For the purpose of the study the ESAS was modified to include two additional items, headache and dizziness. Analysis of the ESAS scores across the different time points will help determine whether VR effects are transient (within 24 hours) or sustained (after 2 and 7 days).
Time Frame
Pre-intervention, post-intervention, 2 day follow up, 7 day follow up
Title
Change in Missoula-VITAS Quality of Life Index (MVQOLI)
Description
The MVQOLI evaluates subjective quality of life among people living with advanced, life-threatening illness by assessing the domains of symptoms, function, interpersonal, wellbeing, and transcendence (Schwartz, Merriman, Reed, & Byock, 2005). Each domain includes three Likert-scale evaluation questions. Analysis of the MVQOLI scores across the different time points will help determine whether VR effects are transient (within 24 hours) or sustained (after 2 and 7 days).
Time Frame
Pre-intervention, post-intervention, 2 day follow up, 7 day follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Admitted to Baycrest PCU Capable to consent to the study Able to complete the outcome measures through a telephone interview with a research assistant Estimated prognosis ≥3 weeks At least 2 or more ESAS scores of 4 or greater within the week of the intervention English speaking Exclusion Criteria: Intractable nausea/vomiting History of seizures or epilepsy Vision and/or hearing impairment that cannot be accommodated e.g. pocket talker Any abnormalities of the head preventing use of the headset Patients who are too unwell to participate based on the opinion of the clinical team
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ginah Kim, MD
Phone
4167852500
Ext
2854
Email
gkim@baycrest.org
First Name & Middle Initial & Last Name or Official Title & Degree
Giulia Perri, MD
Phone
4167852500
Ext
6073
Email
gperri@baycrest.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ginah Kim, MD
Organizational Affiliation
Baycrest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baycrest Health Sciences
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 2E1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ginah Kim, MD
Phone
4167852500
Ext
2854
Email
gkim@baycrest.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
8857241
Citation
Anderson F, Downing GM, Hill J, Casorso L, Lerch N. Palliative performance scale (PPS): a new tool. J Palliat Care. 1996 Spring;12(1):5-11.
Results Reference
background
PubMed Identifier
26059846
Citation
Hui D, Shamieh O, Paiva CE, Perez-Cruz PE, Kwon JH, Muckaden MA, Park M, Yennu S, Kang JH, Bruera E. Minimal clinically important differences in the Edmonton Symptom Assessment Scale in cancer patients: A prospective, multicenter study. Cancer. 2015 Sep 1;121(17):3027-35. doi: 10.1002/cncr.29437. Epub 2015 Jun 8.
Results Reference
background
PubMed Identifier
15662181
Citation
Schwartz CE, Merriman MP, Reed G, Byock I. Evaluation of the Missoula-VITAS Quality of Life Index--revised: research tool or clinical tool? J Palliat Med. 2005 Feb;8(1):121-35. doi: 10.1089/jpm.2005.8.121.
Results Reference
background

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Virtual Reality Therapy to Improve Physical and Psychological Symptoms and Quality of Life for End-of-life Patients on a Palliative Care Unit

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