Contact information
Type
Scientific
Primary contact
Ms Caroline Moore
ORCID ID
http://orcid.org/0000-0003-0202-7912
Contact details
Division of Surgery & Interventional Science
University College London
4th Floor
Rockefeller Building
74 Huntley Street
London
WC1E 6AU
United Kingdom
+44 (0) 207 679 9280
caroline.moore@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CTU/2015/182
Study information
Scientific title
True NTH UK post surgical follow up: development and evaluation of a patient-reported instrument to monitor oncological and functional outcomes after radical prostatectomy
Acronym
True NTH UK Post Surgical Follow up
Study hypothesis
Prostate cancer is the most common cancer in men in the UK, with over 40,000 new diagnoses every year. The most recent estimates suggest there are over 250,000 men in the UK living with and beyond a diagnosis of prostate cancer, and this has been predicted to increase to 831,000 by 2040. Earlier cancer detection, but also effective treatments, are contributing to these increasing survival rates. Radical prostatectomy is a commonly performed operation to treat localised prostate cancer. The National Cancer Intelligence Network reports that around 10% of men with a new diagnosis of prostate cancer have radical prostatectomy.
However, men who choose radical surgery for prostate cancer can experience side effects, including urine leakage and problems with erections. A recent national UK survey has shown that men want to have greater understanding of, and support for these side effects, both before they choose a treatment, and when they are dealing with side effects after treatment. In particular, in the 2013 survey only 64% of men who had prostate cancer treatment said that they were told about possible future side effects of treatment. One of the difficulties in telling men about the possible side effects after prostate cancer surgery is that these side effects will depend upon the urinary and sexual function that a man has prior to the operation, as well as on the details of the operation itself, which is influenced by the location and aggressiveness of the prostate cancer.
A monitoring instrument (MSK instrument) has been developed in the US and adapted for web-based use (“STAR”). It is used to collect patient-reported outcome measures (PROMs) before and after radical prostatectomy in order to monitor functional recovery in individual men. It has been suggested that men find it helpful to keep track of their progress over time and to compare it to that of men like them, although confirmatory data are awaited. Work in Germany has also demonstrated that this type of monitoring after prostatectomy based on patient-reported information can be used by surgeons to identify and support best practice. In addition, such an instrument could potentially be used as a prognostic tool predicting outcomes after radical prostatectomy. This type of prognostic information may inform men who are deciding whether or not they want to undergo a radical prostatectomy.
The True NTH UK Post Surgical Follow up Programme will focus on using patient reported outcome measures (PROMs) to assess the extent and timeline for recovery of urinary and sexual function after radical surgery for prostate cancer. A new instrument will be developed for radical prostatectomy that can be used with men in the UK to monitor their recovery in the first 12 months after surgery. It is envisaged that the PROMs data will be used in clinical practice to monitor progress in outcomes for individual patients. The programme will also allow a comparison of results of surgeons and hospitals against appropriate benchmarks for urinary and sexual outcomes after radical prostatectomy.
Ethics approval
National Research Ethics Committee South Central - Hampshire B, 07/09/2015 , ref: 15/SC/0451
Study design
Observational and cross-sectional study. This is a multi-centre study.
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Prostate cancer
Intervention
Radical prostatectomy
Intervention type
Phase
Drug names
Primary outcome measure
The primary outcome of this study is the new monitoring tool. This study aims to address the following:
1. To develop a new monitoring tool that is suitable for the routine collection of patient reported signs and symptoms, functional status, and health related quality of life before and after radical prostatectomy in the UK
2. To assess to what extent the preoperative results captured with the new monitoring tool can be used – together with other patient characteristics, including comorbidity
and disease characteristics – to predict patient reported functional outcomes (e.g. urinary and sexual function) 12 months after radical prostatectomy
3. To determine appropriate ‘benchmarks’ for urinary and sexual outcomes based on the new monitoring tool against which outcomes of radical prostatectomy surgery can be compared in the UK.
4. To develop a network of radical prostatectomy surgeons who can reflect on the surgical and patient reported outcome data to identify any areas of surgical practice which can be adopted more widely to improve outcomes for men
5. To use the tool to predict patient reported functional outcomes to inform patient led decision making for those men who have a choice of treatment strategies for localized prostate cancer
Secondary outcome measures
There are no secondary outcome measures.
Overall trial start date
07/09/2015
Overall trial end date
31/03/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. A diagnosis of prostate cancer and scheduled to have radical prostatectomy
2. Access to the internet
3. An understanding of the English language sufficient to understand and complete on line CRFs
4. An understanding of the English language sufficient to understand written and verbal information about the trial and consent process
5. Signed informed consent
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
1000
Participant exclusion criteria
Men who are unable to give informed consent.
Recruitment start date
13/11/2015
Recruitment end date
31/03/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College London Hospitals NHS Foundation Trust
250 Euston Road
London
NW1 2PG
United Kingdom
Trial participating centre
North Bristol NHS Trust
Frenchay Hospital
Beckspool Road
Frenchay
Bristol
BS16 1JE
United Kingdom
Trial participating centre
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne, Tyne and Wear
NE7 7DN
United Kingdom
Trial participating centre
Cambridge University Hospitals NHS Foundation Trust
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Trial participating centre
Southampton University Hospitals NHS Trust
Mailpoint 18
Southampton General
Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Trial participating centre
The Royal Marsden NHS Foundation Trust
Fulham Road
London
SW3 6JJ
United Kingdom
Trial participating centre
Guy's And St Thomas' NHS Foundation Trust
Trust Offices
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
Trial participating centre
University Hospital Birmingham NHS Foundation Trust
Rust HQ, PO Box 9551
Queen Elizabeth Medical
Centre
Edgbastontrust Hq, Po Box 9551
Queen Elizabeth Medical
Centre
Edgbaston
Birmingham
B15 2TH
United Kingdom
Trial participating centre
The Christie NHS Foundation Trust
550 Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom
Trial participating centre
Royal Berkshire Hospital
Craven Road
Reading
RG1 5AN
United Kingdom
Trial participating centre
South West London And St George's Mental Health NHS Trust
St George’s Hospital
Blackshaw Road
Tooting, London
SW17 0QT
United Kingdom
Sponsor information
Organisation
University College London
Sponsor details
Clinical Trials Group
Division of Surgery & Interventional Science
Faculty of Medical Sciences
University College London
132 Hampstead Road
London
NW1 2BX
United Kingdom
+44 (0)20 7679 9280
CTG.CTG@ucl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Prostate Cancer UK
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Presentations and publications arising directly from the pre-planned analyses will be the responsibility of the project team.
Other members of the medical and scientific community will be encouraged to submit requests for new analyses of the data set. However, the raw data will remain in the custodianship of the True NTH Post Surgical Follow up Study Operations Group, apart from the transfer of anonymised data to the project team for pre-determined analyses.
Any publications arising from the study will be made publicly available at www.ctgparticipants.org
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list