Ignite Creation Date:
2024-05-06 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03025633
Status:
COMPLETED
Last Update Posted:
2019-07-15
First Post:
2016-12-20
Brief Title:
Explaining the Invisible Using the PEARL System
Sponsor:
Hull University Teaching Hospitals NHS Trust
Organization:
Hull University Teaching Hospitals NHS Trust
Study Overview
Official Title:
Explaining the Invisible - A Study to Evaluate the Effectiveness of Delivering Radiotherapy Treatment Information in a Visual Manner Using the PEARL System
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Radiotherapy uses high doses of x-rays directed at tumours to kill them an unfortunate side effect is healthy surrounding tissue will receive some of the x-ray dose and is damaged Approximately 22 of radiotherapy patients receive treatment to cure prostate cancer The technique used requires patients to maintain full bladder and empty bowel because they are next to the prostate the aim of radiotherapy planning is to minimise the radiation dose received to healthy organs and tissues as this will reduce side effects PEARL is commercial interactive PC software that shows realistic and functional 3D models of Linacs machines that deliver radiotherapy treatment Using PEARL its possible to display realistic patient treatments including how an individual would be laid on a treatment couch and how the machine will move and sound during treatment Additionally PEARL provides the opportunity to look inside the body to view internal anatomy and show where the radiotherapy treatment is directed
Information prior to treatment in radiotherapy is normally given verbally one to one The investigators believe this information can be more easily understood if PEARL is used in conjunction with this verbal exchange PEARL gives visual and audio representation of the treatment experience and demonstrates the reasons behind required preparations
Research aim is to demonstrate patients who receive information using PEARL have greater understanding reduced anxiety and reduced radiation dose This will be tested using two groups of patients receiving radiotherapy to the prostate Group A - Verbal information Group B - Verbal information and PEARL demonstration Data collection is via patient questionnaires and review of Cone Beam Computer Tomography CBCT images that are taken prior to each radiotherapy treatment as standard practice CBCTs are used to locate the treatment area and assess bladder and bowel status and ensure all of these are suitable to deliver treatment accurately
Information prior to treatment in radiotherapy is normally given verbally one to one The investigators believe this information can be more easily understood if PEARL is used in conjunction with this verbal exchange PEARL gives visual and audio representation of the treatment experience and demonstrates the reasons behind required preparations
Research aim is to demonstrate patients who receive information using PEARL have greater understanding reduced anxiety and reduced radiation dose This will be tested using two groups of patients receiving radiotherapy to the prostate Group A - Verbal information Group B - Verbal information and PEARL demonstration Data collection is via patient questionnaires and review of Cone Beam Computer Tomography CBCT images that are taken prior to each radiotherapy treatment as standard practice CBCTs are used to locate the treatment area and assess bladder and bowel status and ensure all of these are suitable to deliver treatment accurately
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None