Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000309987
Ethics application status
Approved
Date submitted
23/01/2020
Date registered
5/03/2020
Date last updated
5/03/2020
Date data sharing statement initially provided
5/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of Virtual Reality (VR) pain psychology therapy to relieve chronic pain associated with cancer.
Scientific title
Virtual Reality pain psychology therapy as non-pharmacological analgesia for cancer-related chronic neuropathic pain.
Secondary ID [1] 300347 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic cancer-related pain 315961 0
Condition category
Condition code
Anaesthesiology 314228 314228 0 0
Pain management
Cancer 314507 314507 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in the intervention arm will receive 3x 30min sessions of VR-pain psychology therapy, as timed by a researcher. Each session will allow one module of the VR-pain therapy to be provided. Timepoints for follow-up is at 1 month, 3 months, and 6 months after recruitment.
Each VR session will occur in separate clinical rooms located within the Cancer Centre Wellness unit at Liverpool Hospital to provide privacy for the patient, and to avoid disturbance to other patients concurrently onsite for their outpatient visits. The VR session will occur after the patient has seen their oncologist.


Our VR software program will incorporate three pain psychological modules:
(1) Patient education on the nature and type of pain, and methods to control pain;
(2) Teaching progressive muscle relaxation as a form of arousal reduction therapy; and
(3) Guided pain visualisation technique to reduce pain catastrophising, reduce maladaptive response to pain, and improve functional outcomes

These modules are selected by patients using their hand-motion controllers. Patients can advance, stop, or rewind the therapy. An electronic representation of a therapist (“avatar”) is projected through the VR goggles that will speak with the patient. Patients are required to be active participants, interacting with the avatar by choosing their therapy options in real time.

The interaction between patient and VR-pain control therapy does not require external intervention from a psychologist. However, the view experienced by the patient is projected onto an external TV. This will be monitored by a researcher, who can intervene if necessary.
Intervention code [1] 316631 0
Treatment: Other
Comparator / control treatment
Patients in the control arm will receive 3x 30min sessions of VR-delivered distraction therapy in the form of movies/videos filmed in VR. This is in contrast to the VR pain psychology therapy in the intervention gorup.

All movies in the control treatment are publicly accessible through the dedicated VR channel from YouTube. Example movies that can be chosen by the patient includes a documentary on jaguars in Brazil
Control group
Active

Outcomes
Primary outcome [1] 323122 0
Acceptability and feasibility endpoint will be assessed by a questionnaire. The questionnaire will ask about the three most commonly known side-effects of VR use: nausea, dizziness, and eyestrain. Patients will score using a 1-10 Visual Analogue Scale on the presence and severity of any of these side-effects. A free text box will be included for extra information or feedback not captured by the questions
Timepoint [1] 323122 0
Before and after each of the three VR sessions.
Secondary outcome [1] 380859 0
Pain score assessed by referral questionnaire from the Australian English (version 2.0) of the Electronic Persistent Pain Outcomes Collaboration (ePPOC).15 ePPOC is an initiative of the Faculty of Pain Medicine, Australian and New Zealand College of Anaesthetists. It is the standardised national data collection form used to measure treatment outcomes and allow coordinated research activity in pain medicine. The questionnaire is a combination of the modified Brief Pain Inventory scale, Depression Anxiety and Stress Scale, Pain Self-Efficacy Questionnaire, Pain Catastrophising Scale, and the Work Productivity and Activity Impairment Questionnaire. ePPOC is designed to be self-administered or may be completed with the assistance of a researcher
Timepoint [1] 380859 0
1 month, 3 months, and 6 months (primary end-point) post-enrolment in the VR group versus the control group
Secondary outcome [2] 380860 0
Quality of Life benefit from VR use, as measured by European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of life Questionnaire (QLQ-C30), 2001 version 3. This is the standardised and validated quality of life 30-item questionnaire for cancer patients in international clinical trials.
Timepoint [2] 380860 0
1 month, 3 months, and 6 months (primary end-point) post-enrolment in the VR group versus the control group

Eligibility
Key inclusion criteria
Adult (greater than or equal to 18yo) patients with cancer, and with the following characteristics:
- Eastern Cooperative Oncology Group (ECOG) score 0-2
- Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) score greater than or equal to 12
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Insufficient written English language proficiency to complete questionnaires.
- Insufficient verbal English language proficiency to interact with the VR software avatar.
- Psychological or psychiatric illness not stabilised with therapy and/or medications.
- Uncertainty or unable to be followed up for subsequent six months after recruitment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sequentially numbered opaque envelopes. Each envelope will have a unique alphanumeric code to allow patients to be de-identified
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomised sequence, in blocks of 4, will be created and placed in sequentially numbered opaque envelopes. . After obtaining fully informed consent, 40 patients will be recruited and allocated to receive VR-pain psychology therapy, or VR-delivered distraction therapy.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary statistical analysis of effectiveness endpoints will compare between controls and groups at follow up timepoints, using repeated measures ANOVA. Potential confounders, such as the Pain Catastrophising Score, Depression Anxiety Stress Scale, and the baseline oMEDD, will be analysed using a backwards stepwise regression to determine influences on effectiveness outcomes

Acceptability results will be summated and averaged over all VR sessions, and presented as separate mean/SD or median/range data for the control and interventional groups. Analysis of acceptability will be performed using either t-test or the Mann-Whitney test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/03/2020
Actual
Date of last participant enrolment
Anticipated
6/06/2020
Actual
Date of last data collection
Anticipated
6/12/2020
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15678 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 29097 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 304773 0
Hospital
Name [1] 304773 0
Department of Anaesthesia. Liverpool Hospital
Country [1] 304773 0
Australia
Primary sponsor type
Individual
Name
A/Prof Alwin Chuan
Address
Department of Anaethesia
Level 1 New Clinical Building
Liverpool Hospital
Elizabeth Street
Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 305088 0
Individual
Name [1] 305088 0
Howard Chow
Address [1] 305088 0
Department of Anaethesia
Level 1 New Clinical Building
Liverpool Hospital
Elizabeth Street
Liverpool NSW 2170
Country [1] 305088 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305188 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 305188 0
Ethics committee country [1] 305188 0
Australia
Date submitted for ethics approval [1] 305188 0
05/11/2019
Approval date [1] 305188 0
18/11/2019
Ethics approval number [1] 305188 0
2019/ETH12974

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99542 0
A/Prof Alwin Chuan
Address 99542 0
Liverpool Hospital, 1 Campbell Street, Liverpool 2071 NSW
Country 99542 0
Australia
Phone 99542 0
+61 407 743 668
Fax 99542 0
Email 99542 0
dr.chuan@iinet.net.au
Contact person for public queries
Name 99543 0
Alwin Chuan
Address 99543 0
Liverpool Hospital, 1 Campbell Street, Liverpool 2071 NSW
Country 99543 0
Australia
Phone 99543 0
+61 407 743 668
Fax 99543 0
Email 99543 0
dr.chuan@iinet.net.au
Contact person for scientific queries
Name 99544 0
Alwin Chuan
Address 99544 0
Liverpool Hospital, 1 Campbell Street, Liverpool 2071 NSW
Country 99544 0
Australia
Phone 99544 0
+61 407 743 668
Fax 99544 0
Email 99544 0
dr.chuan@iinet.net.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics committee has not allowed public sharing of data in the study


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6576Study protocol  dr.chuan@iinet.net.au 379121-(Uploaded-23-01-2020-15-00-11)-Study-related document.docx
6577Informed consent form  dr.chuan@iinet.net.au 379121-(Uploaded-23-01-2020-15-00-32)-Study-related document.docx
6578Ethical approval  dr.chuan@iinet.net.au 379121-(Uploaded-23-01-2020-15-00-52)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.