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Trial registered on ANZCTR


Registration number
ACTRN12619001480178
Ethics application status
Approved
Date submitted
15/10/2019
Date registered
25/10/2019
Date last updated
25/10/2019
Date data sharing statement initially provided
25/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot virtual reality intervention for women with advanced breast cancer
Scientific title
Pilot intervention study assessing how a nature scene VR experience compares with an animated camping VR experience in improving psychological and physical wellbeing in women with advanced breast cancer
Secondary ID [1] 299545 0
Nil known
Universal Trial Number (UTN)
U1111-1239-0882
Trial acronym
VRabc
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 314803 0
Depression 314804 0
Pain 314805 0
Fatigue 314806 0
Condition category
Condition code
Cancer 313145 313145 0 0
Breast
Mental Health 313212 313212 0 0
Depression
Mental Health 313213 313213 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will be exposed to both VR experiences; however, the order of exposure will depend on whether participants are randomised to Group 1(A:B) or Group 2 (B:A). There will be a one-week washout period to minimise carry over effects between the two interventions. During the intervention weeks, participants will use the VR experience every day for a minimum of 10-minutes. Participants can use it for longer if they wish. Participants will keep a written daily log of their VR experience i.e. time of day, length of use and experience they visited. The study will be conducted in the participants home. Participants will be sent the study equipment, this includes the VR headset, headphones, user guide and logbook.

'Ripple' or Intervention A, includes three nature scenes from around New Zealand: 1) a beach in the Abel Tasman where the controller can write words in the sand; 2) a waterfall where the controller can stack stones; and 3) the Southern Alps where the controller can view different perspectives of the mountain top and lake. If participants are in Group one (A:B) they will use "Ripple" for week one; whereas group two (B:A) participants will use ripple in week three.
Intervention code [1] 315797 0
Treatment: Other
Intervention code [2] 315904 0
Treatment: Devices
Comparator / control treatment
Happy Place or Intervention B is a commercially available VR experience. Happy Place takes you to an animated camping scene, Participants can explore the campsite which has interactive features.

Participants will use the "Happy Place" for approximately 10 minutes every day for 7 days. If participants are in group one (A:B) they will use "Happy Place" in week 3; where as group two (B:A) participants will use "Happy Place" in week one.
Control group
Active

Outcomes
Primary outcome [1] 321669 0
Quality of life as measured by the EQ-5D-5L (Herdman et al., 2011).
Timepoint [1] 321669 0
(T1 - day 1) Baseline pre intervention 1, (t2 - day 7) 7 days post commencement of intervention 1, (t4 - day 15) baseline pre intervention 2, (t5- day 21) 7 days post commencement of intervention 2.
Secondary outcome [1] 375840 0
Fatigue – FACIT fatigue scale (Cella, Lai, Chang, Peterman & Slavin, 2002),
Timepoint [1] 375840 0
(T1 - day 1) Baseline pre intervention 1, (t2 - day 7) 7 days post commencement of intervention 1, (t3 - day 9) 48 hours after finishing intervention 1, (t4 - day 15) baseline intervention 2 15-days, (t5- day 21) 7 days post commencement of intervention 2 and (t6 - day 23) 48 hours after finishing intervention 2.
Secondary outcome [2] 375841 0
Pain – Brief Pain Inventory – Short Form (Cleeland & Ryan, 1994),
Timepoint [2] 375841 0
(T1 - day 1) Baseline pre intervention 1, (t2 - day 7) 7 days post commencement of intervention 1, (t3 - day 9) 48 hours after finishing intervention 1, (t4 - day 15) baseline intervention 2 15-days, (t5- day 21) 7 days post commencement of intervention 2 and (t6 - day 23) 48 hours after finishing intervention 2.
Secondary outcome [3] 375842 0
Anxiety, depression and stress – DASS-21 (Lovibond & Lovibond, 1995),
Timepoint [3] 375842 0
(T1 - day 1) Baseline pre intervention 1, (t2 - day 7) 7 days post commencement of intervention 1, (t3 - day 9) 48 hours after finishing intervention 1, (t4 - day 15) baseline intervention 2 15-days, (t5- day 21) 7 days post commencement of intervention 2 and (t6 - day 23) 48 hours after finishing intervention 2.
Secondary outcome [4] 375843 0
Spirituality/sense of purpose – FACIT-Sp12 (Peterman, Fitchett, Brady, Hernandez & Cella, 2002).
Timepoint [4] 375843 0
(T1 - day 1) Baseline pre intervention 1, (t2 - day 7) 7 days post commencement of intervention 1, (t4 - day 15) baseline intervention 2 15-days, (t5- day 21) 7 days post commencement of intervention 2.
Secondary outcome [5] 375844 0
Connectedness to nature – INS Scale (Schultz, 2001).
Timepoint [5] 375844 0
(T1 - day 1) Baseline pre intervention 1, (t2 - day 7) 7 days post commencement of intervention 1, (t4 - day 15) baseline intervention 2 15-days, (t5- day 21) 7 days post commencement of intervention 2
Secondary outcome [6] 375845 0
Relaxation
- Text message 'Please rate your feeling of relaxation right now 0 (not at all relaxed) to 10 (the most relaxed you have every felt.
- log entry - Relaxation rating Before use out of 10
- Relaxation rating After use out of 10
Timepoint [6] 375845 0
23 days of the study day 1 - 23 and before and after using the VR.

Eligibility
Key inclusion criteria
Inclusion criteria are as follows:
• Participant has a diagnosis of metastatic breast cancer.
• Participants are 18 years and older.
• Participants are physically able to wear and tolerate wearing the VR headset for a minimum of 10-minutes a day for 2-weeks.
• Participants have experienced a symptom of fatigue, pain or anxiety in the past 7-days.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if:
• Participants have a visual, hearing, and or cognitive impairment that would limit; the ability to provide informed consent, answer questionnaires, follow written instructions and the use of virtual reality.
• Participants cannot read, speak, or write in English.

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)
Through RedCap. The studies biostatistician who is not involved in recruitment or data collection created the randomisation template and uploaded it to Redcap. The research assistant then uses redcap to generate the allocation after screening for eligibility,.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation was employed. Allocation was stratified by age above and below 50.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Descriptive statistics will include means and 95% confidence intervals for continuous measures and counts and percentages for categorical measures. Normality of the outcome measurements will be assessed visually and using a Shapiro-Wilk test. To verify randomisation, between-group differences at baseline 1 will be analysed using t tests or chi-square tests. Treatment differences for EQ-5D, FACIT-fatigue, BPI-SF, DASS-21 and FACIT-sp scores will be analysed using linear mixed-effects models. Each model will include terms for subject (random), treatment (Ripple or Happy Place) and period, with the difference in baseline scores included as a covariate in the model (Mehrotra, 2014) and all two-way interactions assessed. If a significant interaction is identified, pairwise comparisons will be performed to determine whether the between-group differences in QOL scores are statistically significant. The main hypothesis of interest is the time X group interaction; if significant, this will indicate that the change in outcome (e.g. EQ-5D score) for a given treatment is different across time points, and that this change differs between Ripple and Happy place groups (regardless of baseline value). To test for potential carry-over effects (i.e. to assess whether the wash out period was sufficient), values from the two baselines will be tested as the dependent variable in a model including the order of treatments, treatment type and an order X treatment interaction, with participant included as a random effect. All statistical tests will be two-sided, with significance determined at the 0.05 probability level.

Recruitment
Recruitment status
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] 21921 0
New Zealand
State/province [1] 21921 0

Funding & Sponsors
Funding source category [1] 304033 0
Charities/Societies/Foundations
Name [1] 304033 0
Breast Cancer Foundation NZ
Address [1] 304033 0
Breast Cancer Foundation NZ 11 York St, Parnell, Auckland 1052
Country [1] 304033 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Office of Research and Strategy and Integrity
Private Bag 9201, Auckland
1142, New Zealand

Country
New Zealand
Secondary sponsor category [1] 304223 0
None
Name [1] 304223 0
Address [1] 304223 0
Country [1] 304223 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304524 0
Northern B Health and Disability Ethics Committees
Ethics committee address [1] 304524 0
Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 304524 0
New Zealand
Date submitted for ethics approval [1] 304524 0
04/09/2019
Approval date [1] 304524 0
26/09/2019
Ethics approval number [1] 304524 0
19/NTB/146

Summary
Brief summary
Clinical interventions using virtual reality with cancer patients have shown psychological benefits and reductions in common cancer symptoms such as pain and fatigue.

This proposed study is a randomised controlled trial comparing two virtual reality nature experiences; "Ripple" created by (BCF) which uses real footage of three nature scenes around New Zealand and "Happy Place” a commercial animated camping experience.

The study aims to investigate how the “Ripple” VR experience compares to “Happy Place”, in improving well-being in women with advanced breast cancer. The primary outcome measure quality of life is measured using the EQ-5D-5L (Herdman et al., 2011). Secondary outcome variables, fatigue, pain, psychological distress, spirituality, connectedness to nature and relaxation will be also be assessed. A secondary aim of this study is to determine the duration of effects of the VR experience i.e., how long beneficial effects last following exposure to VR experience.

We hypothesise that both experiences will show improvements in all the outcome variables being assessed, but the real nature experience “Ripple” will show incremental improvements above that of “Happy Place”.
Trial website
https://aakr955.wixsite.com/vrabc
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97258 0
Dr Lisa Reynolds
Address 97258 0
Department of Psychological Medicine
The University of Auckland
Level 12, Room 599 12.097
Auckland City Hospital
Park Road, Grafton
1023
Auckland, New Zealand
Country 97258 0
New Zealand
Phone 97258 0
+64 9 9234938
Fax 97258 0
Email 97258 0
l.reynold@auckland.ac.nz
Contact person for public queries
Name 97259 0
Dr Lisa Reynolds
Address 97259 0
Department of Psychological Medicine
The University of Auckland
Level 12, Room 599 12.097
Auckland City Hospital
Park Road, Grafton
1023
Auckland, New Zealand
Country 97259 0
New Zealand
Phone 97259 0
+64 9 9234938
Fax 97259 0
Email 97259 0
l.reynold@auckland.ac.nz
Contact person for scientific queries
Name 97260 0
Dr Lisa Reynolds
Address 97260 0
Department of Psychological Medicine
The University of Auckland
Level 12, Room 599 12.097
Auckland City Hospital
Park Road, Grafton
1023
Auckland, New Zealand
Country 97260 0
New Zealand
Phone 97260 0
+64 9 9234938
Fax 97260 0
Email 97260 0
l.reynold@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results