Clinical trial NCT03326440: Virtual Environment Radiotherapy to Improve Patients' Compliance to Radiotherapy (RT) in Prostate Cancer
Official title: Virtual Environment Radiotherapy (VERT) to Improve Patients' Compliance to Radiotherapy (RT) in Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Carcinoma
Lead sponsor: University Hospitals of North Midlands NHS Trust
Sponsor class: OTHER
First posted: 2017-10-31
Enrollment: 79
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Purpose of the study

1. To assess whether offering visual information to patients with prostate cancer prior to receiving RT increases the participant's compliance.
2. 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.

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.

Primary outcomes:
measure: Volume of bladder measurement in cm3
timeFrame: Through study completion, an average of seven and a half weeks.
Secondary outcomes:
measure: Does increased compliance translate into reduced side effects from RT.
timeFrame: Through study completion and follow up - an average of 8 months
Other outcomes:
Locations:
city: Stoke on Trent
country: United Kingdom
facility: University Hospitals of North Midlands, Royal Stoke University Hospital, City General Site, Newcaslte Road
state: Staffordshire
Study officials:
affiliation: University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital, Oncology Department, City General Site, Newcastle Road, Stoke on Trent, ST4 6QG
name: Josep Sule-Suso
role: PRINCIPAL_INVESTIGATOR
References: