Clinical trial NCT04966260: 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
Overall status: COMPLETED
Phase: NA
Conditions: End-of-Life
Physical Suffering
Psychological Distress
Keywords: Palliative Care
Symptom management
Virtual Reality
Lead sponsor: Baycrest
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 63
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Change in Edmonton Symptom Assessment Scale (ESAS) Score
timeFrame: Pre-intervention, post-intervention (same day immediately after intervention), 2 day follow up, 7 day follow up
measure: Change in Missoula-VITAS Quality of Life Index (MVQOLI)
timeFrame: Pre-intervention, post-intervention (same day immediately after intervention), 2 day follow up, 7 day follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Baycrest Health Sciences
state: Ontario
Study officials:
affiliation: Baycrest
name: Ginah Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.