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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02995603




Registration number
NCT02995603
Ethics application status
Date submitted
7/12/2016
Date registered
16/12/2016
Date last updated
11/12/2019

Titles & IDs
Public title
Patient Experience and Acceptance of Horizontal Rotation
Scientific title
Nano-X: Patient Experience and Acceptance of Horizontal Rotation
Secondary ID [1] 0 0
Nano-X V1
Universal Trial Number (UTN)
Trial acronym
Nano-X
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Nano-X patient rotation

Experimental: Patient rotation - Patients will be rotated horizontally, using the Nano-X patient rotation system, and asked to complete validated questionnaires to quantify their experience.


Treatment: Devices: Nano-X patient rotation
Patients are required to completed validated questionnaires to quantify their experience of horizontal rotation.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in level of patient anxiety following rotation in the Nano-X Patient Rotation System - Comparison of mean scores of Short Form State/Trait Anxiety Inventory (STAI) Questionnaire outcomes before and after being rotated in the Nano-X Patient Rotation System
Timepoint [1] 0 0
1 hour
Primary outcome [2] 0 0
Change in level of patient motion sickness following rotation in the Nano-X Patient Rotation System - Comparison of mean scores of Fast Motion Sickness Test (FMS) Questionnaire outcomes before and after being rotated in the Nano-X Patient Rotation
Timepoint [2] 0 0
1 hour
Primary outcome [3] 0 0
Correlation between claustrophobia and the change in anxiety and motion sickness of patients following rotation in the Nano-X Patient Rotation System - Correlation between Claustrophobia Questionnaire (CLQ) scores prior to study participation on the anxiety and motion sickness results measured in Outcome 1 and Outcome 2
Timepoint [3] 0 0
1 year

Eligibility
Key inclusion criteria
1. A diagnosis of cancer, any stage

2. =18 years of age

3. Eastern Cooperative Oncology Group (ECOG) status 0-2

4. Currently or previously being treated with radiotherapy

5. Any prior therapy allowed

6. Willing and able to comply with all study requirements

7. Must be able to read and complete questionnaires in English

8. Signed, written informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnant women

2. Mentally impaired patients or patients for whom attaining informed consent would be
difficult (including language barriers)

3. Severe vertigo or recent diagnosis of Benign Paroxysmal Positioning Vertigo

Study design
Purpose of the study
Basic Science
Allocation to intervention
N/A
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
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 in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Prince of Wales Hospital, Sydney
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Patients will complete validated psychometric questionnaires to quantify their experience of
being rotated at different speeds using the Nano-X patient rotation system.
Trial website
https://clinicaltrials.gov/show/NCT02995603
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Keall, Prof
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Paul Keall, Prof
Address 0 0
Country 0 0
Phone 0 0
+61 2 86271185
Fax 0 0
Email 0 0
paul.keall@sydney.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02995603