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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] 308643 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 328555 0
Condition category
Condition code
Cancer 325571 325571 0 0
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] 325105 0
Rehabilitation
Intervention code [2] 325106 0
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] 333408 0
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] 333408 0
Baseline, 2, 4, 6 weeks (primary endpoint) post-commencement of intervention
Primary outcome [2] 333507 0
quality of sleep assessed by the Pittsburgh Sleep Quality Index (PSQI)
Timepoint [2] 333507 0
Baseline, 2, 4, 6 weeks (primary endpoint) post-commencement of intervention
Primary outcome [3] 333508 0
depression assessed by Hospital Anxiety and Depression Scale (HADS) and Beck Depression Inventory (BDI)
Timepoint [3] 333508 0
Baseline, 2, 4, 6 weeks (primary endpoint) post-commencement of intervention
Secondary outcome [1] 416943 0
Health-related physical activity assessed by International Physical Activity Questionnaire (IPAQ)
Timepoint [1] 416943 0
Baseline, 2, 4, 6 weeks post-commencement of intervention
Secondary outcome [2] 416944 0
Daily physical activity measured by Actigraph accelerometer
Timepoint [2] 416944 0
For 168 hours starting from the first intervention
Secondary outcome [3] 417317 0
anxiety (additional primary outcome) assessed by Hospital Anxiety and Depression Scale (HADS)
Timepoint [3] 417317 0
Baseline, 2, 4, 6 weeks (primary endpoint) post-commencement of intervention
Secondary outcome [4] 417318 0
Patients mood (additional primary outcome) assessed by The UWIST Mood Adjective Checklist
Timepoint [4] 417318 0
Baseline, 2, 4, 6 weeks (primary endpoint) post-commencement of intervention
Secondary outcome [5] 417319 0
Cancer coping ability assessed by the Mini-Mental Adjustment to Cancer (Mini-MAC) scale (additional primary outcome)
Timepoint [5] 417319 0
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?
No
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
40
Final
Recruitment outside Australia
Country [1] 25188 0
Poland
State/province [1] 25188 0
Lower Silesia

Funding & Sponsors
Funding source category [1] 312875 0
Self funded/Unfunded
Name [1] 312875 0
Oliver Czech
Country [1] 312875 0
Poland
Funding source category [2] 313037 0
Self funded/Unfunded
Name [2] 313037 0
Iwona Malicka - promoter
Country [2] 313037 0
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] 314551 0
University
Name [1] 314551 0
Department of Physiotherapy, Wroclaw University of Health and Sport Sciences
Address [1] 314551 0
al. I. J. Paderewskiego 35, 51-612 Wroclaw, Poland
Country [1] 314551 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312154 0
Ethical Committee of the University School of Physical Education in Wroclaw
Ethics committee address [1] 312154 0
al. I. J. Paderewskiego 35, 51-612 Wroclaw, Poland
Ethics committee country [1] 312154 0
Poland
Date submitted for ethics approval [1] 312154 0
Approval date [1] 312154 0
12/10/2022
Ethics approval number [1] 312154 0

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 123666 0
Mr Oliver Czech
Address 123666 0
Akademia Wychowania Fizycznego im. Polskich Olimpijczyków we Wroclawiu
al. I. J. Paderewskiego 35
51-612 Wroclaw
Poland
Country 123666 0
Poland
Phone 123666 0
+48 502 916 312
Fax 123666 0
Email 123666 0
oliverek8@o2.pl
Contact person for public queries
Name 123667 0
Mr Oliver Czech
Address 123667 0
Akademia Wychowania Fizycznego im. Polskich Olimpijczyków we Wroclawiu
al. I. J. Paderewskiego 35
51-612 Wroclaw
Poland
Country 123667 0
Poland
Phone 123667 0
+48 502 916 312
Fax 123667 0
Email 123667 0
oliverek8@o2.pl
Contact person for scientific queries
Name 123668 0
Mr Oliver Czech
Address 123668 0
Akademia Wychowania Fizycznego im. Polskich Olimpijczyków we Wroclawiu
al. I. J. Paderewskiego 35
51-612 Wroclaw
Poland
Country 123668 0
Poland
Phone 123668 0
+48 502 916 312
Fax 123668 0
Email 123668 0
oliverek8@o2.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?
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.
When will data be available (start and end dates)?
Only on request. Start date - after analysis, end date not determined.
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator (oliverek8@o2.pl)


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.