Patient Experience and Acceptance of Horizontal Rotation

Cancer Clinical Trial

— Nano-X  

Official title:

Nano-X: Patient Experience and Acceptance of Horizontal Rotation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02995603
• Other study ID #: Nano-X V1
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2019
• Est. completion date: December 2023

Study information

• Verified date: November 2022
• Source: University of Sydney
• Contact: Shona Silvester
• Phone: +61 2 86271185
• Email: shona.silvester[@]sydney.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients will complete validated psychometric questionnaires to quantify their experience of being rotated at different speeds using the Nano-X patient rotation system.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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

Locations

Country	Name	City	State
Australia	Prince of Wales Hospital	Randwick	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
University of Sydney	Prince of Wales Hospital, Sydney

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 hour
Primary	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	1 hour
Primary	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	1 year