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

NCT03326440 | Completed

• 1 other identifier: 772
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose of the study

1. 1.To assess whether offering visual information to patients with prostate cancer prior to receiving RT increases the participant's compliance.
2. 2.To assess whether increased compliance translates into reduced side effects from RT (assessed with a quality of life questionnaire).

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, an average of seven and a half weeks.

Secondary Outcomes (1)

• Does increased compliance translate into reduced side effects from RT.

  Through study completion and follow up - an average of 8 months

Study Arms (2)

Study Arm

OTHER

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.

Other: VERT system

Control Arm

OTHER

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.

Other: VERT system

Interventions

VERT system OTHER

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)

Control Arm; Study Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University Hospitals of North Midlands NHS Trust: lead

Study Sites (1)

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

Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Josep Sule-Suso

  University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital, Oncology Department, City General Site, Newcastle Road, Stoke on Trent, ST4 6QG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2016
• First Posted: October 31, 2017
• Study Start: October 8, 2015
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: October 10, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)