Explaining the Invisible Using the PEARL System

Prostate Cancer Clinical Trial

Official title:

Explaining the Invisible - A Study to Evaluate the Effectiveness of Delivering Radiotherapy Treatment Information in a Visual Manner Using the PEARL System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03025633
• Other study ID #: HullEastYorkshireNHS
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: February 2018

Study information

• Verified date: July 2019
• Source: Hull and East Yorkshire Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 Linac's (machines that deliver radiotherapy treatment). Using PEARL it's 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. CBCT's are used to locate the treatment area and assess bladder and bowel status and ensure all of these are suitable to deliver treatment accurately.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with cancer of the prostate of the following staging: T1-3b, N0-1, M0.

• Clinical intention to treat using external radiotherapy based on three local departmental protocols: TP-CP-97, TP-CP-98 and TP-CP-99. These protocols dictate that the patients receive VMAT planned treatment, require a full bladder and empty rectum and require daily localisation using kV cone beam CT (CBCT).

• Patients consented to the study.

Exclusion Criteria:

• Patients who do not fulfil the inclusion criteria.

• Patients diagnosed with depression.

• Blind patients or patients with severe visual impairment.

• Patients with reduced understanding due to mental impairment.

• Patients not willing to consent to the study.

• Prisoners and young offenders.

• Patients who are unable to understand verbal explanations given in English.

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Other:
• PEARL
PEARL, is a commercially available PC-based tool that provides a realistic and functional 3D model of a linac and, having uploaded example treatments it can demonstrate the treatment procedure and also relevant anatomical information.

Locations

Country	Name	City	State
United Kingdom	Hull and East Yorkshire Hospitals NHS Trust	Hull	East Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Hull and East Yorkshire Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinically significant reduction in the number of CBCT rescans due to protocol non-compliance (resulting from both rectum and bladder non-conformances).		7 Months
Secondary	Statistically significant difference in bladder volume compliance between the two groups.		7 Months
Secondary	A statistically significant reduction in treatment-related anxiety in patients, to be assessed using pre-treatment questionnaires.		7 Months
Secondary	Increased understanding of patients, as perceived by them, regarding the radiotherapy treatment procedure in terms of accurate positioning and need for preparation (rectum/bladder management).		7 Months