Development and evaluation of a patient-reported instrument to monitor oncological and functional outcomes after radical prostatectomy: the true NTH Post Surgery programme

ISRCTN	ISRCTN13511717
DOI	https://doi.org/10.1186/ISRCTN13511717
Protocol serial number	CTU/2015/182
Sponsor	University College London
Funder	Prostate Cancer UK

Submission date: 06/11/2015
Registration date: 23/11/2015
Last edited: 24/11/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Caroline Moore
Scientific

Division of Surgery & Interventional Science
University College London
4th Floor, Rockefeller Building
74 Huntley Street
London
WC1E 6AU
United Kingdom

ORCID ID	0000-0003-0202-7912
Phone	+44 (0) 207 679 9280
Email	caroline.moore@ucl.ac.uk

Study information

Primary study design	Observational
Study design	Observational and cross-sectional study. This is a multi-centre study.
Secondary study design	Cross sectional study
Study type	Participant information sheet
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
Study acronym	True NTH UK Post Surgical Follow up
Study objectives	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(s)	National Research Ethics Committee South Central - Hampshire B, 07/09/2015 , ref: 15/SC/0451
Health condition(s) or problem(s) studied	Prostate cancer
Intervention	Radical prostatectomy
Intervention type
Primary outcome measure(s)	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
Key secondary outcome measure(s)	There are no secondary outcome measures.
Completion date	31/03/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	1000
Key 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
Key exclusion criteria	Men who are unable to give informed consent.
Date of first enrolment	13/11/2015
Date of final enrolment	31/03/2017

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

University College London Hospitals NHS Foundation Trust

250 Euston Road
London
NW1 2PG
United Kingdom

North Bristol NHS Trust

Frenchay Hospital
Beckspool Road
Frenchay
Bristol
BS16 1JE
United Kingdom

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne, Tyne and Wear
NE7 7DN
United Kingdom

Cambridge University Hospitals NHS Foundation Trust

Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Southampton University Hospitals NHS Trust

Mailpoint 18
Southampton General
Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

The Royal Marsden NHS Foundation Trust

Fulham Road
London
SW3 6JJ
United Kingdom

Guy's And St Thomas' NHS Foundation Trust

Trust Offices
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom

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

The Christie NHS Foundation Trust

550 Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom

Royal Berkshire Hospital

Craven Road
Reading
RG1 5AN
United Kingdom

South West London And St George's Mental Health NHS Trust

St George’s Hospital
Blackshaw Road
Tooting, London
SW17 0QT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

20/09/2016: Internal review