Patient Experience and Acceptance of Horizontal Rotation (Nano-X)
Nano-X: Patient Experience and Acceptance of Horizontal Rotation
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Shona Silvester
- Phone Number: +61 2 86271185
- Email: shona.silvester@sydney.edu.au
Study Locations
-
-
New South Wales
-
Randwick, New South Wales, Australia, 2031
- Prince of Wales Hospital
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- A diagnosis of cancer, any stage
- ≥18 years of age
- Eastern Cooperative Oncology Group (ECOG) status 0-2
- Currently or previously being treated with radiotherapy
- Any prior therapy allowed
- Willing and able to comply with all study requirements
- Must be able to read and complete questionnaires in English
- Signed, written informed consent
Exclusion Criteria:
- Pregnant women
- Mentally impaired patients or patients for whom attaining informed consent would be difficult (including language barriers)
- Severe vertigo or recent diagnosis of Benign Paroxysmal Positioning Vertigo
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
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.
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Patients are required to completed validated questionnaires to quantify their experience of horizontal rotation.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in level of patient anxiety following rotation in the Nano-X Patient Rotation System
Time Frame: 1 hour
|
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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1 hour
|
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Change in level of patient motion sickness following rotation in the Nano-X Patient Rotation System
Time Frame: 1 hour
|
Comparison of mean scores of Fast Motion Sickness Test (FMS) Questionnaire outcomes before and after being rotated in the Nano-X Patient Rotation
|
1 hour
|
|
Correlation between claustrophobia and the change in anxiety and motion sickness of patients following rotation in the Nano-X Patient Rotation System
Time Frame: 1 year
|
Correlation between Claustrophobia Questionnaire (CLQ) scores prior to study participation on the anxiety and motion sickness results measured in Outcome 1 and Outcome 2
|
1 year
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Study Chair: Paul Keall, Prof, University of Sydney
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- Nano-X V1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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