ANZCTR - Registration

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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]

None.

Universal Trial Number (UTN)

None.

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

cancer

Mental health

Cognitive disorders

Cognitive functions

Condition category

Condition code

Mental Health

Studies of normal psychology, cognitive function and behaviour

Cancer

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]

Rehabilitation

Intervention code [2]

Prevention

Intervention code [3]

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]

Change of the storage capacity of spatial working memory - CORSI Corsi Block-Tapping Test from the Vienna Test System

Timepoint [1]

- 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]

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]

Primary outcome [3]

Change of assesses attention and concentration - COG Test from the Vienna Test System.

Timepoint [3]

Secondary outcome [1]

Change of verbal fluency - Controlled Oral Association Test (COWAT)

Timepoint [1]

- 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]

Change in the perception of stress - measuring by Perceived Stress Scale - PSS -10 - Juczynski and Oginska-Bulik

Timepoint [2]

Secondary outcome [3]

Change of selective attention, mental flexibility, visual-spatial skills and motor speed (composite outcome) - CTT - Color Trials Test

Timepoint [3]

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

Sex

Both males and females

Can healthy volunteers participate?

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

7/10/2019

Actual

Date of last participant enrolment

Anticipated

1/12/2020

Actual

Date of last data collection

Anticipated

31/12/2021

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Poland

State/province [1]

Lower Silesian

Funding & Sponsors

Funding source category [1]

University

Name [1]

University School of Physical Education in Wroclaw

Address [1]

al. I. J. Paderewskiego 35, 51-612 Wroclaw

Country [1]

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]

Hospital

Name [1]

Lower Silesian Oncology Centre

Address [1]

pl. Hirszfelda 12, 53-413 Wroclaw

Country [1]

Poland

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Medical University Wroclaw

Ethics committee address [1]

Wybrzeze Ludwika Pasteura 1, 50-367 Wroclaw

Ethics committee country [1]

Poland

Date submitted for ethics approval [1]

Approval date [1]

23/03/2017

Ethics approval number [1]

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

Prof Grzegorz Zurek

Address

University School of Physical Education,
al. I. J. Paderewskiego 35
Wroclaw 51-612

Country

Poland

Phone

+48 71 347 33 66

Fax

[email protected]

Contact person for public queries

Name

Grzegorz Zurek

Address

University School of Physical Education,
al. I. J. Paderewskiego 35
Wroclaw 51-612

Country

Poland

Phone

+48 71 347 33 66

Fax

[email protected]

Contact person for scientific queries

Name

Grzegorz Zurek

Address

University School of Physical Education,
al. I. J. Paderewskiego 35
Wroclaw 51-612

Country

Poland

Phone

+48 71 347 33 66

Fax

[email protected]

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?

Doc. No.	Type	Email	Attachment
3881	Ethical approval	[email protected]	377780-(Uploaded-07-08-2019-23-11-13)-Study-related document.pdf
4614	Informed consent form	[email protected]
4616	Study protocol	[email protected]
4617	Clinical study report	[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Evaluating the Effectiveness of Visuospatial Memory Stimulation Using Virtual Reality in Head and Neck Cancer Patients-Pilot Study.	2023	https://dx.doi.org/10.3390/cancers15061639

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically