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Trial registered on ANZCTR


Registration number
ACTRN12619001279112
Ethics application status
Approved
Date submitted
27/06/2019
Date registered
17/09/2019
Date last updated
17/09/2019
Date data sharing statement initially provided
17/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Application of virtual reality in the stimulation of cognitive functions of oncological patients.
Scientific title
Application of virtual reality in the stimulation of selected cognitive functions of oncological patients.
Secondary ID [1] 298492 0
None.
Universal Trial Number (UTN)
None.
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer 313269 0
Mental health 313270 0
Cognitive disorders 313271 0
Cognitive functions 313272 0
Condition category
Condition code
Mental Health 311714 311714 0 0
Studies of normal psychology, cognitive function and behaviour
Cancer 312101 312101 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention, which will be a stay in the virtual world through the use of goggles and a program for virtual reality. The number of cases in which the intervention will be delivered is 60.
Films will be selected by the project manager individually for each patient to interest and engage him/her, not to get bored or frightened. The videos come from the Oculus Rift goggle database, www.wirtualnagra.pl and ww.youtube.com. An exemplary movie can be watched at https://www.youtube.com/watch?v=mlOiXMvMaZo
The participant will be subjected to this method 3 times a week for about 30 minutes in each week of radiotherapy/chemotherapy (about 3 weeks) at a set time. The date and time of the session will be agreed between the participant and the attending physician but will be between 14:30 and 16:00.
During the intervention, the participant will be under the care of a person responsible for research - an employee of the Department of Neuroscience from the University School of Physical Education in Wroclaw.
The method of delivery is direct and individual for each participant.
Place - Lower Silesia Oncology Center in Wroclaw. Department of Radiotherapy.
All participants will have a common database of films used during their stay in virtual reality. Each patient will be individually adjusted to the sharpness of the image, adjusted to the sharpness of vision and the goggles will be adjusted to the shape of the skull.
The participant's examination using the tests from the Vienna Test System (CORSI - Corsi Block-Tapping Test, DT - Determination Test, COG - Change of assesses attention and concentration) and the PSS-10 (Perceived Stress Scale), CTT (Color Trials Test), COWAT (Controlled Oral Association) tests will take place during the following periods:
1st study - before the beginning of radiotherapy, duration: about 40 minutes
2nd study - directly after the end of the first radiotherapy, duration: about 40 minutes
3rd study - three months after the end of radiotherapy, duration: about 40 minutes
4th study - six months after the end of radiotherapy, duration: about 40 minutes
Intervention code [1] 314740 0
Rehabilitation
Intervention code [2] 315185 0
Prevention
Intervention code [3] 315186 0
Treatment: Devices
Comparator / control treatment
Patients who are not eligible for the programme will not have any intervention. During this time, they will be in a hospital. This time is usually spent sleeping, reading or walking in the corridor.
Control group
Active

Outcomes
Primary outcome [1] 320407 0
Change of the storage capacity of spatial working memory - CORSI Corsi Block-Tapping Test from the Vienna Test System
Timepoint [1] 320407 0
- before the first anti-cancer therapy
- after the first anti-cancer therapy (primary timepoint)
- after all anti-cancer therapy
- after 3 months from the end of anti-cancer therapy
- after 6 months from the end of anti-cancer therapy
Primary outcome [2] 320408 0
The measure of the respondent’s reactive stress tolerance and ability to react under stress conditions (composite outcome) - Test DT - Determination Test from the Vienna Test System.
Timepoint [2] 320408 0
- before the first anti-cancer therapy
- after the first anti-cancer therapy (primary timepoint)
- after all anti-cancer therapy
- after 3 months from the end of anti-cancer therapy
- after 6 months from the end of anti-cancer therapy
Primary outcome [3] 320411 0
Change of assesses attention and concentration - COG Test from the Vienna Test System.
Timepoint [3] 320411 0
- before the first anti-cancer therapy
- after the first anti-cancer therapy (primary timepoint)
- after all anti-cancer therapy
- after 3 months from the end of anti-cancer therapy
- after 6 months from the end of anti-cancer therapy
Secondary outcome [1] 371494 0
Change of verbal fluency - Controlled Oral Association Test (COWAT)
Timepoint [1] 371494 0
- before the first anti-cancer therapy
- after the first anti-cancer therapy
- after all anti-cancer therapy
- after 3 months from the end of anti-cancer therapy
- after 6 months from the end of anti-cancer therapy
Secondary outcome [2] 371495 0
Change in the perception of stress - measuring by Perceived Stress Scale - PSS -10 - Juczynski and Oginska-Bulik
Timepoint [2] 371495 0
- before the first anti-cancer therapy
- after the first anti-cancer therapy
- after all anti-cancer therapy
- after 3 months from the end of anti-cancer therapy
- after 6 months from the end of anti-cancer therapy
Secondary outcome [3] 371559 0
Change of selective attention, mental flexibility, visual-spatial skills and motor speed (composite outcome) - CTT - Color Trials Test

Timepoint [3] 371559 0
- before the first anti-cancer therapy
- after the first anti-cancer therapy
- after all anti-cancer therapy
- after 3 months from the end of anti-cancer therapy
- after 6 months from the end of anti-cancer therapy

Eligibility
Key inclusion criteria
- aware agreement on participating in the study
- diagnosed cancer
- positive medical diagnosis
- no previous sign of cognitive impairment and co-existing diseases that cause cognitive impairment
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- patient in terminal disease stage with a negative medical prognosis
- precedent chemotherapy treatment
- coexistent disease with symptoms of cognitive functions dysfunctions
- lack of consent to participate in the study

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
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
Statistical analysis of the collected data will be performed using the STATISTICA program in the Laboratory of Statistical Analyses, holding the ISO 9001 certificate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21604 0
Poland
State/province [1] 21604 0
Lower Silesian

Funding & Sponsors
Funding source category [1] 303037 0
University
Name [1] 303037 0
University School of Physical Education in Wroclaw
Address [1] 303037 0
al. I. J. Paderewskiego 35, 51-612 Wroclaw
Country [1] 303037 0
Poland
Primary sponsor type
University
Name
University School of Physical Education in Wroclaw
Address
al. I. J. Paderewskiego 35, 51-612 Wroclaw
Country
Poland
Secondary sponsor category [1] 303019 0
Hospital
Name [1] 303019 0
Lower Silesian Oncology Centre
Address [1] 303019 0
pl. Hirszfelda 12, 53-413 Wroclaw
Country [1] 303019 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303590 0
Medical University Wroclaw
Ethics committee address [1] 303590 0
Wybrzeze Ludwika Pasteura 1, 50-367 Wroclaw
Ethics committee country [1] 303590 0
Poland
Date submitted for ethics approval [1] 303590 0
Approval date [1] 303590 0
23/03/2017
Ethics approval number [1] 303590 0
KB-105/2017

Summary
Brief summary
It seems that stimulation of the nervous system with external stimuli may have a beneficial effect on cognitive functions, e.g. memory, speed of reaction, fluency of speech, etc. For this purpose, we will use virtual reality as a cognitive training for cancer patients in the hospital. It has been proven that hospitalization, stress and fatigue have an adverse effect on brain function. The aim of the study is to determine whether the use of mental stimulation in the form of staying in virtual reality affects cognitive functions of oncological patients undergoing radiotherapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94178 0
Prof Grzegorz Zurek
Address 94178 0
University School of Physical Education,
al. I. J. Paderewskiego 35
Wroclaw 51-612
Country 94178 0
Poland
Phone 94178 0
+48 71 347 33 66
Fax 94178 0
Email 94178 0
grzegorz.zurek@awf.wroc.pl
Contact person for public queries
Name 94179 0
Prof Grzegorz Zurek
Address 94179 0
University School of Physical Education,
al. I. J. Paderewskiego 35
Wroclaw 51-612
Country 94179 0
Poland
Phone 94179 0
+48 71 347 33 66
Fax 94179 0
Email 94179 0
grzegorz.zurek@awf.wroc.pl
Contact person for scientific queries
Name 94180 0
Prof Grzegorz Zurek
Address 94180 0
University School of Physical Education,
al. I. J. Paderewskiego 35
Wroclaw 51-612
Country 94180 0
Poland
Phone 94180 0
+48 71 347 33 66
Fax 94180 0
Email 94180 0
grzegorz.zurek@awf.wroc.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator
What supporting documents are/will be available?
Study protocol
Informed consent form
Clinical study report
Ethical approval
How or where can supporting documents be obtained?
Type [1] 3881 0
Ethical approval
Citation [1] 3881 0
Link [1] 3881 0
Email [1] 3881 0
grzegorz.zurek@awf.wroc.pl
Other [1] 3881 0
Type [2] 4614 0
Informed consent form
Citation [2] 4614 0
Link [2] 4614 0
Email [2] 4614 0
grzegorz.zurek@awf.wroc.pl
Other [2] 4614 0
Attachment [2] 4614 0
Type [3] 4616 0
Study protocol
Citation [3] 4616 0
Link [3] 4616 0
Email [3] 4616 0
grzegorz.zurek@awf.wroc.pl
Other [3] 4616 0
Attachment [3] 4616 0
Type [4] 4617 0
Clinical study report
Citation [4] 4617 0
Link [4] 4617 0
Email [4] 4617 0
grzegorz.zurek@awf.wroc.pl
Other [4] 4617 0
Attachment [4] 4617 0
Summary results
No Results