Patient Experience and Acceptance of Horizontal Rotation

NCT ID: NCT02995603

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-14

Study Completion Date

2025-06-30

Brief Summary

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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

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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.

Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Patient rotation

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

Group Type EXPERIMENTAL

Nano-X patient rotation

Intervention Type DEVICE

Patients are required to completed validated questionnaires to quantify their experience of horizontal rotation.

Interventions

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Nano-X patient rotation

Patients are required to completed validated questionnaires to quantify their experience of horizontal rotation.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prince of Wales Hospital, Sydney

OTHER_GOV

Sponsor Role collaborator

University of Sydney

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Keall, Prof

Role: STUDY_CHAIR

University of Sydney

Locations

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Prince of Wales Hospital

Randwick, New South Wales, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Shona Silvester

Role: CONTACT

+61 2 86271185

Facility Contacts

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Michael Jackson, A/Prof

Role: primary

+61 2 9382 8873

Meg Schneider, BN

Role: backup

+61 2 9382 2507

Other Identifiers

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Nano-X V1

Identifier Type: -

Identifier Source: org_study_id

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