Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000347763
Ethics application status
Approved
Date submitted
31/01/2022
Date registered
25/02/2022
Date last updated
25/02/2022
Date data sharing statement initially provided
25/02/2022
Date results information initially provided
25/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does virtual reality in the preoperative setting for colorectal cancer surgery improve patient understanding? A randomised pilot study.
Scientific title
Does virtual reality in the preoperative setting for colorectal cancer surgery improve patient understanding? A randomised pilot study.
Secondary ID [1] 306318 0
None
Universal Trial Number (UTN)
Trial acronym
VR CRC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer 325084 0
Patient understanding in consent for surgery 325085 0
Condition category
Condition code
Cancer 322510 322510 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Public Health 322511 322511 0 0
Health promotion/education
Surgery 322560 322560 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients discussed the diagnosis and planned procedure with their colorectal surgeon to sign a standard consent form and discuss trial participation. For all patients, this was the first consultation to discuss surgery for their bowel cancer. During this encounter, the surgeon could use drawings and information sheets to aid discussion but not the patient’s computed tomography (CT) images. Patients were then taken to a separate office by the researcher during the same clinic appointment. In the intervention group, case discussion was done with both 2D CT images and virtual reality (VR) images to allow for comparison. Patients in the intervention group received a brief 2-5 minute orientation regarding the headsets and controllers before being shown 2 different VR models while seated. The first model was a representative model of the large bowel with superimposed bony and skin anatomy created from a de-identified patient CT colonography. This virtual environment allowed patients to orient themselves to key surface and bony anatomy while also learning to use the controllers on instruction from the researcher. The second model was an individualised VR reconstruction created from patient’s own preoperative staging CT scans. Patients had unlimited use of the controllers to scroll through and view the model from all angles in the virtual environment, where key anatomy was pointed out by the researcher who was not in the virtual environment but giving verbal instructions while monitoring the VR environment on a computer screen. On average the intervention group spent 40 minutes with the researcher.
To standardise the information given to both trial groups, a checklist of key discussion points was followed including key relational anatomy, tumour location and procedure/complication specific anatomy. Headsets and controllers were wiped down with Tuffie 5 universal sanitising wipes between patients.

Image generation
To create the VR models, Deidentified Digital Imaging and Communications in Medicine (DICOM) data for each CT were imported into D2P software (3D Systems Inc, Melbourne Aus.) and relevant anatomy segmented using standard software modules and a dedicated Acer Nitro 5 laptop. D2P employs a technique known as image segmentation, which identifies each relevant anatomical structure separately and enables them to be independently rendered. Each individual structure is assigned a unique colour (thereby enhancing visual differentiation), and may also be hidden from view to focus on the most critical structures and relationships. Segmentation of the large bowel on the representative VR model took 12 hours to complete due to the high level of detail achieved.

Intervention code [1] 322746 0
Treatment: Devices
Intervention code [2] 322783 0
Behaviour
Comparator / control treatment
After a standard consult with the surgeon (blinded), all patients will be shown their 2D CT images with the researcher. These images are in greyscale and permit viewing of only one ‘slice’ of the body at one time, in only 3 planes (coronal, axial or sagittal). This group will not be exposed to Virtual Reality images. On average the control group spent 20 minutes with researcher.
Control group
Active

Outcomes
Primary outcome [1] 330305 0
Patient-rated subjective understanding of the proposed colorectal operation assessed using a 5-point Likert scale
Timepoint [1] 330305 0
Immediately post-intervention completion
Primary outcome [2] 330355 0
Objective understanding of the proposed colorectal operation assessed using a knowledge comprehension question designed specifically for this study
Timepoint [2] 330355 0
Immediately after intervention
Secondary outcome [1] 405678 0
Feasibility assessed as the proportion of eligible participants recruited, refusal rates and estimation of required sample size. The method of data collection for recruitment and refusal rates were recorded in a study enrolment log.
Timepoint [1] 405678 0
Cumulative data will be assessed at the conclusion of the trial

Eligibility
Key inclusion criteria
Inclusion criteria will be participants age 18 years and over who are planned for elective colorectal cancer resection.
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 from the study based on history of vestibulocochlear abnormalities, diagnosis of epilepsy, stroke within the last 3 months, head or neck injury preventing safe use of the VR headsets or diagnosed cognitive impairment

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/11/2021
Date of last participant enrolment
Anticipated
Actual
23/01/2022
Date of last data collection
Anticipated
Actual
23/01/2022
Sample size
Target
10
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 21651 0
St John of God Midland Public Hospital - Midland
Recruitment postcode(s) [1] 36695 0
6056 - Midland

Funding & Sponsors
Funding source category [1] 310665 0
Hospital
Name [1] 310665 0
St John of God Midland Hospital
Country [1] 310665 0
Australia
Primary sponsor type
Hospital
Name
St John of God Hospital
Address
1 Clayton St, Midland WA 6009
Country
Australia
Secondary sponsor category [1] 311880 0
None
Name [1] 311880 0
None
Address [1] 311880 0
None
Country [1] 311880 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310255 0
St John of God Health Care Human Research Ethics Committee
Ethics committee address [1] 310255 0
Level 1, 556 Wellington Street, Perth WA 6000
Ethics committee country [1] 310255 0
Australia
Date submitted for ethics approval [1] 310255 0
Approval date [1] 310255 0
25/10/2021
Ethics approval number [1] 310255 0

Summary
Brief summary
The purpose of this study is to assess whether virtual reality (VR) is a feasible technique for improving patient understanding for the purposes of consent for surgery in individuals with colorectal cancer.

Who is it for?
You may be eligible for this study if you are aged 18 years or older and are planned for elective surgical resection of colorectal cancer.

Study details
After their standard consultation with the colorectal surgeon, participants will be randomised (i.e. allocated by chance) to undergo either standard consent process or VR consent. All participants will be shown their 2D CT images with the researcher as a part of standard consent, which will take approximately 20 minutes. These images are in greyscale and permit viewing of only one ‘slice’ of the body at one time. Following this, participants in the VR consent group will additionally be shown immersive VR three dimensional models of the anatomy and pathology relevant to the proposed surgery, which will take an additional 20 minutes. Immediately after completion, participants will answer a questionnaire to determine their understanding of the proposed operation and satisfaction with the consent process. Data will also be collected to determine the feasibility and cost of delivering VR consent to patients.

It is hoped that this study may show that VR is feasible, effective, and acceptable to patients for obtaining consent prior to surgery for colorectal cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117026 0
Dr Talia Shepherd
Address 117026 0
General Surgery Department, 1 Clayton St Midland WA 6009
Country 117026 0
Australia
Phone 117026 0
+61 413 783 560
Fax 117026 0
Email 117026 0
talia.shepherd@health.wa.gov.au
Contact person for public queries
Name 117027 0
Dr Talia Shepherd
Address 117027 0
General Surgery Department, 1 Clayton St Midland WA 6009
Country 117027 0
Australia
Phone 117027 0
+61 413 783 560
Fax 117027 0
Email 117027 0
talia.shepherd@health.wa.gov.au
Contact person for scientific queries
Name 117028 0
Dr Talia Shepherd
Address 117028 0
General Surgery Department, 1 Clayton St Midland WA 6009
Country 117028 0
Australia
Phone 117028 0
+61 413 783 560
Fax 117028 0
Email 117028 0
talia.shepherd@health.wa.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
Not approved by ethics committee. Only deidentified aggregate data will be presented due to small numbers and therefore risk of inadvertent breach of patient confidentialty.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14854Study protocol  talia.shepherd@health.wa.gov.au
14855Ethical approval  talia.shepherd@health.wa.gov.au



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.