Clinical trial NCT02995434: Immersive Multimedia as an Adjunctive Measure for Pain Control in Cancer Patients
Official title: Immersive Multimedia as an Adjunctive Measure for Pain Control in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Cancer
Keywords: Virtual Reality
Cancer Survivorship
Pain Management
Cancer Pain Management
Chronic Pain Management
Adjunctive Pain Management
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Lotte & John Hecht Memorial Foundation
name: Simon Fraser University
name: Fraser Health
First posted: 2016-12-16
Enrollment: 110
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study seeks to explore the efficacy of immersive multimedia experiences as a practical adjunctive therapeutic intervention in the self-management of the chronic pain associated with cancer patients. A comparative controlled interventional trial and qualitative interpretative-descriptive exploration will be undertaken with 100 cancer patients who are experiencing chronic pain. Participants will be randomly assigned to either a virtual reality (VR) therapy group or a 2D computer based multimedia control group (50 subjects in each).

They will undertake either a series of VR interventions, or 2D computer based multimedia control sessions in their own homes over a period of a month. The intervention will be used daily for a month to enable customization to the therapy and record data over a long enough period of time to account for any individual short-term changes in pain.

The VR sessions will consist of using a VR head mounted display (HMD) and computer to explore interactive immersive environments. The control group will be exposed to similar 2D computer based multimedia experiences (without a VR headset) that on home computers. Pre, during, and post pain test scores and quality of sleep assessments will be recorded using standardized tools.

In addition to the primary study, a sub-study will be conducted where ten of the subjects who demonstrated the most improvement in their pain using the VR experience will be selected and invited to explore for any measurable changes in neurological activity using pre and post exposure electroencephalography (EEG).

Detailed description: This study seeks to explore the efficacy of an immersive multimedia experience as a practical therapeutic intervention in the self-management of the chronic pain associated with cancer patients.

This work will inform further clinical studies and future research into the potential uses of immersive multimedia in the treatment of cancer associated pain. Furthermore, it will help identify optimal immersive multimedia environments for use in chronic pain applications, practical determinants for implementation of immersive multimedia for wider practice, and will provide a better theoretical understanding of the mechanisms whereby immersive multimedia works in chronic pain.

JUSTIFICATION

Cancer survivorship refers to individuals who have remained cancer free for a minimum of 5 years. Due to developments and greater outcomes associated with cancer therapy and management, the number of individuals who survive cancer has risen considerably over the past decade. Currently, 65% of adults and 80% of children can be expected to live at least 5 years post cancer diagnosis. However, for some, survivorship is associated with debilitating chronic pain which impacts negatively on quality of life. Reviews have suggested that up to 40% of individuals have survived cancer remain with cancer related chronic pain.

With rapidly emerging immersive multimedia technologies and clinical work in this field, it would appear that immersive multimedia may have significant potential for use as an adjunctive therapeutic measure for pain control. However, there has been little work done to establish the potential use of immersive multimedia in the management of chronic cancer pain to date, as most work on immersive multimedia for pain management has focused on acute pain via distraction. Several researchers have recommended the investigation of immersive multimedia for chronic, long term pain, and the research team completed a pilot study in 2015 to establish best methods and approaches for using immersive multimedia in chronic pain conditions.

OBJECTIVES

To determine if immersive multimedia therapy is effective as an adjunctive intervention in the management of chronic pain in cancer patients?

1. Can exposure to a immersive multimedia environment as an adjunctive pain-relieving measure provide a pain-reducing experience for for chronic cancer pain patients?
2. How long (if at all) do any therapeutic effects of immersive multimedia last after exposure in chronic cancer pain patients?
3. Are there any significant side effects of immersive multimedia exposure for chronic cancer pain patients?
4. Do any identifiable neurological changes occur on EEG pre and post immersive multimedia exposure?

RESEARCH METHODS

A longitudinal mixed-methods study to evaluate the impact of immersive multimedia for chronic pain in cancer patients is proposed which will consist of a comparative controlled interventional trial and qualitative interpretative-descriptive exploration.

1. Interventional Trial (Quantitative):

   Participants will be randomly assigned to either a VR therapy group or the control group (50 subjects in each). They will undertake either a series of immersive VR interventions, or control sessions (using 2D multimedia on personal computers) in their own homes over a period of a month.

   To ensure the multi-dimensional aspects of chronic pain experienced by individuals are measured adequately, pain assessment tools have been selected that will address different aspects of each participant's' chronic pain and functional capacity. To measure the impact of VR on each participant's pain intensity, the Visual Analog Scale will be used during the VR and control experiences, pre and post exposure and at 10 minute intervals. In order to measure the change in pain during the therapy experience, and overall sleep quality, at the end of each week, participants will also be asked to complete post-intervention questionnaires: Health Survey (Short-Form 12), McGill Pain Questionnaire, the Pittsburgh Sleep Quality Index, and also a brief Virtual Reality Immersion Tool (to assess how immersive they found the experience that week).
2. Interpretive Description Study (Qualitative):

A Qualitative Interpretative-Descriptive exploration will be undertaken alongside the trial to allow for a more open exploration of participants experiences and to further understanding of the perceptions associated with the use of immersive multimedia and any impact upon their chronic pain. An interpretative description (ID) approach will be used for this aspect of the study. This methodology allows for an inductive descriptive analysis of the phenomena, and was chosen as it is ideal for small scale studies, allowing for generation of themes, patterns and theory associated with the patient's experience.

Following the completion of the clinical trial all participants will be sent an exploratory questionnaire to discover their perceptions of immersive multimedia and its value (if any) in the control of their chronic pain. In this questionnaire they will also be invited to participate in one of two focus group interviews. Data from this will be analyzed and used to support purposeful sampling of individuals to take part in the following focus-group interviews, to include those subjects with a range of diverse opinions and ideas. As themes and categories emerge from the data the researchers will seek to adapt the focus-group interview sample with the purpose of strengthening the emerging theory and patterns by including individuals who will help further define the characteristics of these themes and categories.

Data Analysis

Quantitative Data: Descriptive and inferential statistical analysis will be performed on the pain scores. For face-value quantitative indicators of potential effects univariate descriptive statistics will be employed. Data will be analyzed for central tendency, dispersion (standard deviation, interquartile range), skewness and kurtosis using SPSS statistical analysis software to establish distribution and variance. Likewise, quantitative data from the questionnaires will be analysed in this fashion. Data will be explored for differences in the pain scales for the VR group and the control group at each time point to analyze for any indications of changes immediately following the experience using Linear Mixed Effects Modelling using SPSS software.

Qualitative Data: The focus-group interviews will be audiotaped. The questionnaire open text results and transcriptions of focus groups will be recorded into NVivo 11.0 qualitative data analysis software and read, re-read and coded for thematic elements by the PIs.

Eligibility criteria: Inclusion Criteria:

* Age 16 or older
* Previous or current medical diagnosis of cancer
* Previous or current treatment by chemotherapy, radiotherapy, hormonal
* Currently an outpatient (not hospitalized)
* Chronic pain sufferer (suffering ongoing daily pain for 3 months or more with a Neuropathic Rating Pain Scale score of 4 or more)
* Able to understand the English language, and read and write English
* Have normal stereoscopic (binocular) vision
* Able to easily move your head up, down, left and right and wear a headset
* Have fine motor control in one hand sufficient to operate a joystick/control
* Have space at home for a computer and monitor equipment

Exclusion Criteria:

* Cognitive impairment/inability to control a basic computer VR interface, or complete questionnaires
* Receiving regular non-pharmacological pain relieving adjunct therapies for the management of chronic pain
* Susceptibility to motion sickness/cyber-sickness
* Susceptibility to claustrophobia (fear of confined places)
* History of susceptibility to seizures

Primary outcomes:
measure: Change in Visual Analog Scale (VAS)
timeFrame: Right before intervention (Pre), during intervention (During) and right after intervention (Post)
Secondary outcomes:
measure: McGill Pain Questionnaire
timeFrame: Before the start of the weekly VR session and after the weekly VR session for a period of 4 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: Before the start of the weekly VR session and after the weekly VR session for a period of 4 weeks
measure: 12 Item Short Form Health Survey (SF-12) Physical Health Component Score
timeFrame: Before the start of the weekly VR session and after the weekly VR session for a period of 4 weeks
measure: 12 Item Short Form Health Survey (SF-12) Mental Health Component Score
timeFrame: Before the start of the weekly VR session and after the weekly VR session for a period of 4 weeks
Other outcomes:
Locations:
city: Surrey
country: Canada
facility: Simon Fraser University - School of Interactive Arts and Technology
state: British Columbia
city: Vancouver
country: Canada
facility: University of British Columbia - School of Nursing
state: British Columbia
city: Vancouver
country: Canada
facility: BC Cancer
state: British Columbia
Study officials:
affiliation: University of British Columbia - School of Nursing
name: Bernard M Garrett, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: