search
Back to results

Virtual Environment Radiotherapy to Improve Patients' Compliance to Radiotherapy (RT) in Prostate Cancer (VERT)

Primary Purpose

Prostate Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
VERT system
Sponsored by
University Hospitals of North Midlands NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prostate Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with the histological diagnosis of prostate cancer due to receive radical RT.
  • Patients with prostate cancer deemed fit enough to complete a course of radical RT to their prostate area.
  • Patients able to give informed consent.

Exclusion Criteria:

  • The only exclusion criteria is for participants unable to understand the study aims and therefore unable to give informed consent.

Sites / Locations

  • University Hospitals of North Midlands, Royal Stoke University Hospital, City General Site, Newcaslte Road

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Study Arm

Control Arm

Arm Description

Patients with a histological diagnosis of prostate cancer are shown how Radiotherapy is planned and given using 3D images on the VERT (Virtual Environment Radiotherapy) system prior to the start of Radiotherapy.

Patients with a histological diagnosis of prostate cancer who are shown how Radiotherapy is planned and given using 3D images on the VERT (Virtual Environment Radiotherapy) system following completion of Radiotherapy.

Outcomes

Primary Outcome Measures

Volume of bladder measurement in cm3
Measuring the bladder volume during Radiotherapy to assess if offering visual information to patients with prostate cancer prior to receiving radiotherapy increases their compliance.

Secondary Outcome Measures

Does increased compliance translate into reduced side effects from RT.
Data collection regarding radiotherapy side effects will be collected throughout the radiotherapy sessions and for 6 months after the radiotherapy

Full Information

First Posted
October 26, 2016
Last Updated
October 9, 2019
Sponsor
University Hospitals of North Midlands NHS Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT03326440
Brief Title
Virtual Environment Radiotherapy to Improve Patients' Compliance to Radiotherapy (RT) in Prostate Cancer
Acronym
VERT
Official Title
Virtual Environment Radiotherapy (VERT) to Improve Patients' Compliance to Radiotherapy (RT) in Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 8, 2015 (undefined)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals of North Midlands NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Purpose of the study To assess whether offering visual information to patients with prostate cancer prior to receiving RT increases the participant's compliance. To assess whether increased compliance translates into reduced side effects from RT (assessed with a quality of life questionnaire). Type of study. This is a randomised control trial which will include 170 patients with the histological diagnosis of prostate cancer in the study arm and 170 patients with the histological diagnosis of prostate cancer in the control/standard arm.
Detailed Description
The Oncology Department at the Royal Stoke University Hospital is a state of the art facility. It has radiotherapy (RT) facilities such as IMRT and rapid arc, leading the way in RT planning and delivery. The Investigators want to further their expertise and public involvement in RT planning with this proposal. This study follows a pilot study in which patients receiving RT were shown how treatment is planned and given using a 3 dimensional (3D) imaging system. It was noticed that patients with prostate cancer entering the pilot study might have been more compliant (holding water before each treatment session) than those with prostate cancer not entering the study. On this basis, the investigators wish to run this project in which prostate cancer patients will be shown how RT is planned and given using 3D images prior to start RT (study arm, 170 patients) or after completion of RT (control/standard arm, 170 patients). A sample size calculation was performed (see below) in order to distinguish a 10% improvement in retention of bladder volume over the course of treatment. RT planning will be carried out using standard procedures at the Oncology Department. However, each study patient's CT Scan image will be placed in the Virtual Environment for Radiotherapy Training (VERT) system. The original images will not be altered and will be presented using the established JImage Dicom libraries. 3D models will be constructed from the CT Images. The system allows moving the 3D images using a mouse. Planning CT Scans will be taken prior to RT, on the first 3 days, and once weekly during RT to measure bladder volumes (this is standard practice and no patients will have extra CT Scans). The investigators will assess whether patients in the study arm were more compliant in holding water when compared to control cases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Carcinoma

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Study Arm
Arm Type
Other
Arm Description
Patients with a histological diagnosis of prostate cancer are shown how Radiotherapy is planned and given using 3D images on the VERT (Virtual Environment Radiotherapy) system prior to the start of Radiotherapy.
Arm Title
Control Arm
Arm Type
Other
Arm Description
Patients with a histological diagnosis of prostate cancer who are shown how Radiotherapy is planned and given using 3D images on the VERT (Virtual Environment Radiotherapy) system following completion of Radiotherapy.
Intervention Type
Other
Intervention Name(s)
VERT system
Intervention Description
3D images of radiotherapy planning and administration using the VERT (Virtual Environment Radiotherapy) system is shown either prior to Radiotherapy (study arm) or post Radiotherapy (control arm)
Primary Outcome Measure Information:
Title
Volume of bladder measurement in cm3
Description
Measuring the bladder volume during Radiotherapy to assess if offering visual information to patients with prostate cancer prior to receiving radiotherapy increases their compliance.
Time Frame
Through study completion, an average of seven and a half weeks.
Secondary Outcome Measure Information:
Title
Does increased compliance translate into reduced side effects from RT.
Description
Data collection regarding radiotherapy side effects will be collected throughout the radiotherapy sessions and for 6 months after the radiotherapy
Time Frame
Through study completion and follow up - an average of 8 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with the histological diagnosis of prostate cancer due to receive radical RT. Patients with prostate cancer deemed fit enough to complete a course of radical RT to their prostate area. Patients able to give informed consent. Exclusion Criteria: The only exclusion criteria is for participants unable to understand the study aims and therefore unable to give informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josep Sule-Suso
Organizational Affiliation
University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital, Oncology Department, City General Site, Newcastle Road, Stoke on Trent, ST4 6QG
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals of North Midlands, Royal Stoke University Hospital, City General Site, Newcaslte Road
City
Stoke on Trent
State/Province
Staffordshire
ZIP/Postal Code
ST4 6QG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Virtual Environment Radiotherapy to Improve Patients' Compliance to Radiotherapy (RT) in Prostate Cancer

We'll reach out to this number within 24 hrs