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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02995603
Registration number
NCT02995603
Ethics application status
Date submitted
7/12/2016
Date registered
16/12/2016
Titles & IDs
Public title
Patient Experience and Acceptance of Horizontal Rotation
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Scientific title
Nano-X: Patient Experience and Acceptance of Horizontal Rotation
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Secondary ID [1]
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Nano-X V1
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Universal Trial Number (UTN)
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Trial acronym
Nano-X
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cancer
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in level of patient anxiety following rotation in the Nano-X Patient Rotation System
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Assessment method [1]
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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
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Timepoint [1]
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1 hour
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Primary outcome [2]
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Change in level of patient motion sickness following rotation in the Nano-X Patient Rotation System
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Assessment method [2]
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Comparison of mean scores of Fast Motion Sickness Test (FMS) Questionnaire outcomes before and after being rotated in the Nano-X Patient Rotation
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Timepoint [2]
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1 hour
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Primary outcome [3]
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Correlation between claustrophobia and the change in anxiety and motion sickness of patients following rotation in the Nano-X Patient Rotation System
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Assessment method [3]
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Correlation between Claustrophobia Questionnaire (CLQ) scores prior to study participation on the anxiety and motion sickness results measured in Outcome 1 and Outcome 2
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Timepoint [3]
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1 year
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Other
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/12/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2025
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Prince of Wales Hospital - Randwick
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Recruitment postcode(s) [1]
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2031 - Randwick
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Sydney
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Address
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Country
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Other collaborator category [1]
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Government body
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Name [1]
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Prince of Wales Hospital, Sydney
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT02995603
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Paul Keall, Prof
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Address
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University of Sydney
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Country
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0
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Phone
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Fax
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Email
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0
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Contact person for public queries
Name
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Shona Silvester
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Address
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Country
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Phone
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+61 2 86271185
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Fax
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Email
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shona.silvester@sydney.edu.au
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02995603