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Explaining the Invisible Using the PEARL System

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
PEARL
Sponsored by
Hull University Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring PEARL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hull and East Yorkshire Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Group A - PEARL

Group B - NON PEARL

Arm Description

Group A will receive a combination of verbal and visual pre-treatment information via the use of PEARL.

Group B will receive verbal only pre-treatment information.

Outcomes

Primary Outcome Measures

Clinically significant reduction in the number of CBCT rescans due to protocol non-compliance (resulting from both rectum and bladder non-conformances).

Secondary Outcome Measures

Statistically significant difference in bladder volume compliance between the two groups.
A statistically significant reduction in treatment-related anxiety in patients, to be assessed using pre-treatment questionnaires.
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).

Full Information

First Posted
December 20, 2016
Last Updated
July 11, 2019
Sponsor
Hull University Teaching Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03025633
Brief Title
Explaining the Invisible Using the PEARL System
Official Title
Explaining the Invisible - A Study to Evaluate the Effectiveness of Delivering Radiotherapy Treatment Information in a Visual Manner Using the PEARL System
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hull University Teaching Hospitals NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
PEARL

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A - PEARL
Arm Type
Other
Arm Description
Group A will receive a combination of verbal and visual pre-treatment information via the use of PEARL.
Arm Title
Group B - NON PEARL
Arm Type
No Intervention
Arm Description
Group B will receive verbal only pre-treatment information.
Intervention Type
Other
Intervention Name(s)
PEARL
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinically significant reduction in the number of CBCT rescans due to protocol non-compliance (resulting from both rectum and bladder non-conformances).
Time Frame
7 Months
Secondary Outcome Measure Information:
Title
Statistically significant difference in bladder volume compliance between the two groups.
Time Frame
7 Months
Title
A statistically significant reduction in treatment-related anxiety in patients, to be assessed using pre-treatment questionnaires.
Time Frame
7 Months
Title
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).
Time Frame
7 Months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria A Sykes, BSc (Hons)
Organizational Affiliation
Hull University Teaching Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hull and East Yorkshire Hospitals NHS Trust
City
Hull
State/Province
East Yorkshire
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Explaining the Invisible Using the PEARL System

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