ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12623000085673

Ethics application status

Approved

Date submitted

18/12/2022

Date registered

25/01/2023

Date last updated

25/01/2023

Date data sharing statement initially provided

25/01/2023

Type of registration

Retrospectively registered

Titles & IDs

Public title

Effect of virtual therapy on rehabilitation of women diagnosed with breast cancer

Scientific title

The effect of virtual therapy on quality of life and mental health outcomes in women undergoing rehabilitation for breast cancer

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Breast cancer

Condition category

Condition code

Cancer

Breast

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention based on the VRTierOne system will be used as an additional intervention. Participation in the experimental group does not result in the loss of other available forms of therapy. 8, 20-minute therapeutic sessions are planned, carried out over 2 weeks. Patients will be supervised by physiotherapists trained to use the system by the manufacturer and a psychotherapist, substantive care covering the psychophysical condition of patients will be provided by Professors of the University of Physical Education in Wroclaw, medical care covering the general health of patients by breast unit. Sessions are held in the form of individual meetings, in a room excluded from use for purposes other than scientific and therapeutic during the research period. The session starts with putting on virtual reality (VR) goggles with headphones. After starting the session, the patient is always in the same virtual environment (garden) and listens to the voice of the therapist conducting therapy in the Ericksonian style. In some sessions, the patient receives a movement task for the upper limb consisting of drawing. The system automatically marks the presence of patients and by entering an individual patient code each time directs to the next session until the end of therapy in session number 8.

Intervention code [1]

Rehabilitation

Intervention code [2]

Treatment: Devices

Comparator / control treatment

Control treatment is the standard of care treatment for breast cancer patients. In this case in control conditions there are no interventions. The study will compare participants in several groups: chemotherapy, radiotherapy, surgical and a group immediately after diagnosis. The results from the chemotherapy experimental group will be compared with the result of chemotherapy control group etc.

Control group

Active

Outcomes

Primary outcome [1]

quality of life (assessed by European Organisation for. Research and Treatment of Cancer Quality of Life Questionnaire for cancer patients (EORTC QLQ-C30)

Timepoint [1]

Baseline, 2, 4, 6 weeks (primary endpoint) post-commencement of intervention

Primary outcome [2]

quality of sleep assessed by the Pittsburgh Sleep Quality Index (PSQI)

Timepoint [2]

Baseline, 2, 4, 6 weeks (primary endpoint) post-commencement of intervention

Primary outcome [3]

depression assessed by Hospital Anxiety and Depression Scale (HADS) and Beck Depression Inventory (BDI)

Timepoint [3]

Baseline, 2, 4, 6 weeks (primary endpoint) post-commencement of intervention

Secondary outcome [1]

Health-related physical activity assessed by International Physical Activity Questionnaire (IPAQ)

Timepoint [1]

Baseline, 2, 4, 6 weeks post-commencement of intervention

Secondary outcome [2]

Daily physical activity measured by Actigraph accelerometer

Timepoint [2]

For 168 hours starting from the first intervention

Secondary outcome [3]

anxiety (additional primary outcome) assessed by Hospital Anxiety and Depression Scale (HADS)

Timepoint [3]

Baseline, 2, 4, 6 weeks (primary endpoint) post-commencement of intervention

Secondary outcome [4]

Patients mood (additional primary outcome) assessed by The UWIST Mood Adjective Checklist

Timepoint [4]

Baseline, 2, 4, 6 weeks (primary endpoint) post-commencement of intervention

Secondary outcome [5]

Cancer coping ability assessed by the Mini-Mental Adjustment to Cancer (Mini-MAC) scale (additional primary outcome)

Timepoint [5]

Baseline, 2, 4, 6 weeks (primary endpoint) post-commencement of intervention

Eligibility

Key inclusion criteria

Malignant breast cancer, no cognitive impairments, written consent

Minimum age

18 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

None

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)

Randomisation software, central randomisation by a computer software.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software

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

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

1/10/2021

Date of last participant enrolment

Anticipated

30/06/2023

Actual

Date of last data collection

Anticipated

11/08/2023

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment outside Australia

Country [1]

Poland

State/province [1]

Lower Silesia

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Oliver Czech

Address [1]

Akademia Wychowania Fizycznego im. Polskich Olimpijczyków we Wroclawiu al. I. J. Paderewskiego 35 51-612 Wroclaw Poland

Country [1]

Poland

Funding source category [2]

Self funded/Unfunded

Name [2]

Iwona Malicka - promoter

Address [2]

Akademia Wychowania Fizycznego im. Polskich Olimpijczyków we Wroclawiu al. I. J. Paderewskiego 35 51-612 Wroclaw Poland

Country [2]

Poland

Primary sponsor type

Individual

Name

Iwona Malicka - promoter

Address

Akademia Wychowania Fizycznego im. Polskich Olimpijczyków we Wroclawiu
al. I. J. Paderewskiego 35
51-612 Wroclaw
Poland

Country

Poland

Secondary sponsor category [1]

University

Name [1]

Department of Physiotherapy, Wroclaw University of Health and Sport Sciences

Address [1]

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

Country [1]

Poland

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethical Committee of the University School of Physical Education in Wroclaw

Ethics committee address [1]

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

Ethics committee country [1]

Poland

Date submitted for ethics approval [1]

Approval date [1]

12/10/2022

Ethics approval number [1]

Summary

Brief summary

Cancer diseases appear today as a particularly important issue due to health, psychological and social consequences. In Poland, as in other European countries, breast cancer is the most frequently diagnosed cancer among women. The peak incidence falls on the age of 65-69, however, the number of cases diagnosed in younger women is increasing. The greatest increase in incidence is observed after the age of 40. This means that breast cancer more and more often affects women who are fully active in professional, family and social life.
Cancer is one of the most traumatic experiences in human life. There are unknown emotions associated with the diagnosis of cancer, its treatment and fear related to the prognosis. This usually has a negative impact on psychophysical well-being.
The use of virtual reality (VR) in medicine is gaining more and more supporters. Both immersive and non-immersive virtual reality find their application, e.g. in surgery, rehabilitation, neurology and play a special role in educating future doctors. VR allows you to simulate surgical procedures and supports the course of complex operations, it is used in rehabilitation to improve cognitive and motor functions, it is also a popular tool in psychology because it can be used as a relaxation therapy. The main difference between immersive and non-immersive VR is the amount of stimuli provided to the user. Immersion technology allows you to affect almost all senses and completely isolate the patient from the real world. Virtual reality seems to be a new and effective tool that distracts the patient from medical procedures, which can also contribute to improving the quality of life and reducing the undesirable effects of oncological treatment, translating into the promotion of an active lifestyle in this area among oncological patients.
The characteristics of cancer and VR therapy seem to be matched in terms of expectations and possibilities. By analyzing current scientific reports, virtual reality systems may be the optimal tool in reducing the negative effects of cancer, and research goals result directly from the available knowledge.

Trial website

Trial related presentations / publications

Public notes

The research team has conducted a pilot study with another ethical approval. The previous study however, was not registered. Therefore some of the participants could be enrolled before the ethical approval, which was updated after finding a possibility to improve the study value. (e.g. Actigraph measurement of Physical activity.)

Contacts

Principal investigator

Name

Mr Oliver Czech

Address

Akademia Wychowania Fizycznego im. Polskich Olimpijczyków we Wroclawiu al. I. J. Paderewskiego 35 51-612 Wroclaw Poland

Country

Poland

Phone

+48 502 916 312

Fax

[email protected]

Contact person for public queries

Name

Oliver Czech

Address

Akademia Wychowania Fizycznego im. Polskich Olimpijczyków we Wroclawiu al. I. J. Paderewskiego 35 51-612 Wroclaw Poland

Country

Poland

Phone

+48 502 916 312

Fax

[email protected]

Contact person for scientific queries

Name

Oliver Czech

Address

Akademia Wychowania Fizycznego im. Polskich Olimpijczyków we Wroclawiu al. I. J. Paderewskiego 35 51-612 Wroclaw Poland

Country

Poland

Phone

+48 502 916 312

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• only researchers who provide a methodologically sound proposal

Conditions for requesting access:
• -

What individual participant data might be shared?

• Only the overall, statistically information (e.g. sample mean age, BMI, gender etc.) as well as the questionnaire results (anonymous). Also, all questionnaires are named by participants code, not personal data.

What types of analyses could be done with individual participant data?

• any purpose

When can requests for individual participant data be made (start and end dates)?

From:
Only on request. Start date

To:
after analysis, end date not determined.

Where can requests to access individual participant data be made, or data be obtained directly?

• access subject to approvals by Principal Investigator ([email protected])

Are there extra considerations when requesting access to individual participant data?

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

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically