Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001473752
Ethics application status
Approved
Date submitted
8/11/2022
Date registered
23/11/2022
Date last updated
15/09/2024
Date data sharing statement initially provided
23/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility and preliminary effectiveness of virtual reality as a patient education tool for people with cancer undergoing immunotherapy: a randomised controlled pilot study in a regional setting
Scientific title
Feasibility and preliminary effectiveness of virtual reality as a patient education tool for people with cancer undergoing immunotherapy: a randomised controlled pilot study in a regional setting
Secondary ID [1] 308369 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 328162 0
Patient education 328163 0
Condition category
Condition code
Cancer 325215 325215 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients undergoing immunotherapy will be recruited and randomised to one of three groups.
Participants randomised to Arm A will receive the 60 minute standard of care (SoC) education session plus a single one-off immersive, 3D 360° virtual reality (VR) experience.

The SoC education is delivered either on the first day of the patient’s immunotherapy treatment session or a previous day. The patients randomised to Arm A will receive the VR experience after the SoC education has been provided. The VR experience will be delivered whilst the patient is receiving their first immunotherapy treatment.

The VR intervention will be delivered by an experienced, trained trial coordinator (i.e; trial nurse) with the use of a gaming laptop (i.e., Gigabyte AORUS 17G XC 17.3-inch Core i7 RTX 3070) and Oculus Quest 2 headset. Participants will be able to move around the immersive environment by using hand controllers and hand tracking, or with the help of the trial coordinator. The VR world will explain and show patients how the immune system reacts to the immunotherapy treatment, what side-effects may occur, and what patients should do in case they experience any of these side-effects related to the immunotherapy treatment. The video will last approximately 5-7 minutes. Participants will be seated throughout the session.

The total time required to explain and set up the intervention, answer any questions, and administer the intervention is anticipated to be no longer than the immunotherapy treatment session, which usually takes about 30 to 90 minutes.

The trial nurse will be present during the VR experience to assure adherence.

Participants randomised to Arm B will receive the 60 minute SoC education and in addition will be shown a single, one-off 2D video on immunotherapy. The video will be a 2D replica of the immersive, 3D 360° VR experience patients receive when randomized to the VR intervention (Arm A) and will last 5-7 minutes.

The patients randomised to Arm B will view the 2D video after the SoC education session has been provided. Participants will view the 2D video whilst receiving their first immunotherapy treatment. Patients will watch the video on a laptop.
Intervention code [1] 324883 0
Treatment: Devices
Comparator / control treatment
Participants allocated to Arm C (control group) will receive the SoC education session only. The session takes 60 minutes and includes nursing led verbal education on immunotherapy and the use of printed educational material i.e; 3840-Advanced, metastatic or recurrent pembrolizumab eviQ handout.
Control group
Active

Outcomes
Primary outcome [1] 333056 0
Feasibility as measured by the recruitment rate - the number of patients approached, number consenting to participate, and those eligible to be randomized. This is a composite measure. The source of this data is an Enrolment Log.
Timepoint [1] 333056 0
Cumulative data regarding recruitment will be assessed at the completion of the study.
Primary outcome [2] 333057 0
Feasibility as measured by the practicality of the intervention - time taken for VR intervention as recorded by the trial nurse.
Timepoint [2] 333057 0
Time 1 (during the first immunotherapy session)
Primary outcome [3] 333058 0
Feasibility as measured by the acceptability and usability of VR as an immunotherapy education tool for patients - via a 20-30 minute semi-structured interview with patients with a member of the research team over the phone or via video call.
Timepoint [3] 333058 0
1-3 days after first immunotherapy session and VR intervention
Secondary outcome [1] 415665 0
Feasibility as measured by the acceptability and usability of VR as a patient education tool for patients - via a 20-30 minute semi-structured interview with health professionals ( i.e trial nurses) with a member of the research team over the phone or via video call. (primary outcome)
Timepoint [1] 415665 0
1-3 days after first immunotherapy session and VR intervention
Secondary outcome [2] 415666 0
Feasibility as measured by the safety of the VR intervention - number of attributable adverse events recorded by the trial coordinator. Possible adverse events associated with VR include,: general discomfort, fatigue, headache, eyestrain, difficulty focusing, increased salivation, sweating, nausea, difficulty concentrating, fullness of head, blurred vision, dizziness, vertigo, stomach awareness and burping (primary outcome).
Timepoint [2] 415666 0
Time 1 (first session of immunotherapy treatment and following the intervention)
Secondary outcome [3] 415667 0
Knowledge about immunotherapy on a 20 item true/false questionnaire designed specifically for the study (primary outcome).
Timepoint [3] 415667 0
At Baseline and Time 1 ( primary endpoint - first session of immunotherapy treatment and following the intervention)
Secondary outcome [4] 415668 0
Perceived information provision on the European Organization for Research and Treatment Quality-of-Life Group Information Questionnaire (EORTC QLQ-INFO25) (primary outcome)
Timepoint [4] 415668 0
At Baseline and Time 1 (primary endpoint - first session of immunotherapy treatment and following the intervention)
Secondary outcome [5] 415669 0
Patient activation on Patient Activation Measure (PAM-13) (primary outcome)
Timepoint [5] 415669 0
At Baseline and Time 1 (primary endpoint - first session of immunotherapy treatment and following the intervention)
Secondary outcome [6] 420897 0
Knowledge about immunotherapy over time on a 20 item true/false questionnaire designed specifically for the study.
Timepoint [6] 420897 0
Time 2 (two weeks after first immunotherapy session)
Secondary outcome [7] 420898 0
Perceived information provision over time on the European Organization for Research and Treatment Quality-of-Life Group Information Questionnaire (EORTC QLQ-INFO25)
Timepoint [7] 420898 0
Time 2 (two weeks after first immunotherapy session)
Secondary outcome [8] 420899 0
Patient activation over time on Patient Activation Measure (PAM-13)
Timepoint [8] 420899 0
Time 2 (two weeks after first immunotherapy session)
Secondary outcome [9] 420900 0
Knowledge about immunotherapy on a 20 item true/false questionnaire designed specifically for the study stratified by patient information coping styles, as assessed with the shortened version of the Threatening Medical Situations Inventory (TMSI)
Timepoint [9] 420900 0
Time 1 (first session of immunotherapy treatment and following the intervention) and Time 2
(two weeks after first immunotherapy session)
Secondary outcome [10] 420901 0
Perceived information provision on the European Organization for Research and Treatment Quality-of-Life Group Information Questionnaire (EORTC QLQ-INFO25) stratified by patient information coping styles, as assessed with the shortened version of the Threatening Medical Situations Inventory (TMSI)
Timepoint [10] 420901 0
Time 1 (first session of immunotherapy treatment and following the intervention) and Time 2
(two weeks after first immunotherapy session)
Secondary outcome [11] 420902 0
Patient activation on Patient Activation Measure (PAM-13) stratified by patient information coping styles, as assessed with the shortened version of the Threatening Medical Situations Inventory (TMSI)
Timepoint [11] 420902 0
Time 1 (first session of immunotherapy treatment and following the intervention) and Time 2
(two weeks after first immunotherapy session)

Eligibility
Key inclusion criteria
Patients will be eligible to participate if they meet the following criteria:

a) are 18 years and over,

b) are diagnosed with a reportable cancer of any stage (e.g., melanoma, kidney cancer, mesothelioma, lung cancer) that will be treated with immunotherapy alone,

c) are due to start only immunotherapy agents (i.e., patients may not receive any other treatment, such as chemotherapy or radiotherapy),

d) are able to understand English, and

e) are able to give their own consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they:

a) have a condition that interferes with VR usage, including but not limited to seizures, facial injury precluding safe placement of headset, and visual impairments;

b) have a prognosis of <3 months from the time of enrolment per treating oncologist or;

c) receiving other systemic cancer therapies in combination with immunotherapy

d) have a pre-existing severe mental health diagnosis or significant cognitive impairment, such as severe dementia that would impair their comprehension and/or ability to provide informed consent

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The random set of allocations will be sealed in consecutively numbered opaque envelopes, and given to participants by the lead researcher, who will be concealed to group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated set of random allocations
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
1) Feasibility outcomes
Recruitment data will be summarized using a rate and 95% CI using the Poisson distribution. Acceptability and appropriateness of study measures will be summarized using a proportion and 95% CI, which will be estimated using the Wilson method. The practicality of VR (i.e., time spent by the study coordinator completing intervention-related activity) will be recorded in the trial coordinator’s data collection instrument, including total time spent per patient as well as activity-specific time (e.g., intervention preparation). Any adverse events related to the use of VR will also be recorded in the study coordinator’s data collection instrument. Means and SDs will be used to summarize time data.
2) Effectiveness outcomes
Descriptive and inferential statistical analysis will be used to explore the feasibility and preliminary effectiveness of the VR on the dependent variables (i.e., information provision, knowledge, and patient activation). Data will be analysed according to the intention-to-treat analysis method. Linear, multilevel regression analysis, with random intercept on patient level to adjust for intra-dependency between repeated measures, will be used to assess the impact of VR on patient-reported outcomes (i.e., information provision, knowledge, and patient activation). An interaction term of information coping style and trial arm (control will be the reference group and will be compared to the intervention groups), with selected covariates, will be added to assess the moderating effect of information coping style on the outcome measures.

The analyses will be stratified by information coping style whenever the interaction term of coping style and trial arm is significant.
Patient information coping style will measured at baseline on the shortened version of the Threatening Medical Situations Inventory (TMSI).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/05/2024
Actual
5/09/2024
Date of last participant enrolment
Anticipated
15/05/2025
Actual
Date of last data collection
Anticipated
17/11/2025
Actual
Sample size
Target
36
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23522 0
Orange Health Service - Orange
Recruitment postcode(s) [1] 38935 0
2800 - Orange

Funding & Sponsors
Funding source category [1] 312613 0
Charities/Societies/Foundations
Name [1] 312613 0
Cancer Care West NSW Inc
Country [1] 312613 0
Australia
Funding source category [2] 312615 0
Commercial sector/Industry
Name [2] 312615 0
AstraZeneca Australia
Country [2] 312615 0
Australia
Funding source category [3] 312616 0
Commercial sector/Industry
Name [3] 312616 0
Bristol Myers Squibb
Country [3] 312616 0
Australia
Funding source category [4] 312617 0
Commercial sector/Industry
Name [4] 312617 0
Roche Australia
Country [4] 312617 0
Australia
Primary sponsor type
Hospital
Name
Central West Cancer Care Centre, Orange Health Service
Address
1530 Forest Road
Orange NSW 2800
Country
Australia
Secondary sponsor category [1] 314226 0
None
Name [1] 314226 0
Nil
Address [1] 314226 0
Nil
Country [1] 314226 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311934 0
Greater Western Human Research Ethics Committee
Ethics committee address [1] 311934 0
Ethics committee country [1] 311934 0
Australia
Date submitted for ethics approval [1] 311934 0
26/08/2022
Approval date [1] 311934 0
21/10/2022
Ethics approval number [1] 311934 0
2022/ETH01760

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

Contacts
Principal investigator
Name 122894 0
A/Prof Robert Zielinski
Address 122894 0
Central West Cancer Care Centre, Orange Health Service
1530 Forest Road, Orange NSW 2800
Country 122894 0
Australia
Phone 122894 0
+61 026369 3380
Fax 122894 0
Email 122894 0
rob.zielinski@health.nsw.gov.au
Contact person for public queries
Name 122895 0
Robert Zielinski
Address 122895 0
Central West Cancer Care Centre, Orange Health Service
1530 Forest Road, Orange NSW 2800
Country 122895 0
Australia
Phone 122895 0
+61 026369 3380
Fax 122895 0
Email 122895 0
rob.zielinski@health.nsw.gov.au
Contact person for scientific queries
Name 122896 0
Robert Zielinski
Address 122896 0
Central West Cancer Care Centre, Orange Health Service
1530 Forest Road, Orange NSW 2800
Country 122896 0
Australia
Phone 122896 0
+61 026369 3380
Fax 122896 0
Email 122896 0
rob.zielinski@health.nsw.gov.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 approval not received for IPD


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFeasibility and preliminary effectiveness of virtual reality as a patient education tool for people with cancer undergoing immunotherapy: A protocol for a randomised controlled pilot study in a regional setting.2023https://dx.doi.org/10.1136/bmjopen-2022-071080
N.B. These documents automatically identified may not have been verified by the study sponsor.