Explaining the Invisible Using the PEARL System

July 11, 2019 updated by: Hull University Teaching Hospitals NHS Trust

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
155

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • East Yorkshire
      • Hull, East Yorkshire, United Kingdom, HU16 5JQ
        • Hull and East Yorkshire Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: Group A - PEARL
Group A will receive a combination of verbal and visual pre-treatment information via the use of PEARL.
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.
NO_INTERVENTION: Group B - NON PEARL
Group B will receive verbal only pre-treatment information.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
7 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Statistically significant difference in bladder volume compliance between the two groups.
Time Frame: 7 Months
7 Months
A statistically significant reduction in treatment-related anxiety in patients, to be assessed using pre-treatment questionnaires.
Time Frame: 7 Months
7 Months
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
7 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hull University Teaching Hospitals NHS Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Victoria A Sykes, BSc (Hons), Hull University Teaching Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2017

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HullEastYorkshireNHS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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