Patient Experience and Acceptance of Horizontal Rotation

Not Applicable

Recruiting

• Conditions: Cancer
• Interventions: Device: Nano-X patient rotation

• Registration Number: NCT02995603
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2016-12-07
• Study First Submitted QC: 2016-12-13
• Study First Posted: 2016-12-16
• Study Start: 2019-12-14
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in level of patient motion sickness following rotation in the Nano-X Patient Rotation System	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
Correlation between claustrophobia and the change in anxiety and motion sickness of patients following rotation in the Nano-X Patient Rotation System	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
Change in level of patient anxiety following rotation in the Nano-X Patient Rotation System	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

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇦🇺 Randwick, New South Wales, Australia