Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Patient Experience and Acceptance of Horizontal Rotation (Nano-X)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02995603
Recruitment Status : Recruiting
First Posted : December 16, 2016
Last Update Posted : December 11, 2019
Sponsor:
Collaborator:
Prince of Wales Hospital, Sydney
Information provided by (Responsible Party):
University of Sydney

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.

Condition or disease Intervention/treatment Phase
Cancer Device: Nano-X patient rotation Not Applicable

Detailed Description:
Study participants will be asked to attend the clinic on two separate occasions. Each session will last less than one hour. Patients will be asked to complete validated psychometric surveys assessing 1) their level of claustrophobia, 2) their level of anxiety and 3) their (baseline) motion sickness, before and after each session. They will then be rotated 3-4 times on the Nano-X patient rotation system, at varying speeds ranging from 6°/sec to 45°/sec. Each rotation will be designed to simulate a typical radiotherapy treatment; that is 9 angles, pausing for around 30 seconds at each angle. Straight after each rotation, patients will again complete the questionnaire assessing their anxiety levels and motion sickness.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Nano-X: Patient Experience and Acceptance of Horizontal Rotation
Actual Study Start Date : December 4, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/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.
Device: Nano-X patient rotation
Patients are required to completed validated questionnaires to quantify their experience of horizontal rotation.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02995603


Contacts
Layout table for location contacts
Contact: Paul Keall, Prof +61 2 86271185 paul.keall@sydney.edu.au
Contact: Natalie Plant, Masters +61 2 86271133 natalie.plant@sydney.edu.au

Locations
Layout table for location information
Australia, New South Wales
Prince of Wales Hospital Recruiting
Randwick, New South Wales, Australia, 2031
Contact: Michael Jackson, A/Prof    +61 2 9382 8873    michael.jackson2@health.nsw.gov.au   
Contact: Meg Schneider, BN    +61 2 9382 2507    meg.schneider@health.nsw.gov.au   
Sponsors and Collaborators
University of Sydney
Prince of Wales Hospital, Sydney
Investigators
Layout table for investigator information
Study Chair: Paul Keall, Prof University of Sydney
Layout table for additonal information
Responsible Party: University of Sydney
ClinicalTrials.gov Identifier: NCT02995603    
Other Study ID Numbers: Nano-X V1
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Sydney:
Radiotherapy
Rotation