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
Secondary identifying numbers CTU/2015/182
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 logo 0000-0003-0202-7912
+44 (0) 207 679 9280
caroline.moore@ucl.ac.uk

Study information

Study designObservational and cross-sectional study. This is a multi-centre study.
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleTrue NTH UK post surgical follow up: development and evaluation of a patient-reported instrument to monitor oncological and functional outcomes after radical prostatectomy
Study acronymTrue NTH UK Post Surgical Follow up
Study objectivesProstate 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) studiedProstate cancer
InterventionRadical prostatectomy
Intervention type
Primary outcome measureThe 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 measuresThere are no secondary outcome measures.
Overall study start date07/09/2015
Completion date31/03/2017

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target number of participants1000
Key inclusion criteria1. 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 criteriaMen who are unable to give informed consent.
Date of first enrolment13/11/2015
Date of final enrolment31/03/2017

Locations

Countries of recruitment

  • England
  • United Kingdom

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

Sponsor information

University College London
University/education

Clinical Trials Group
Division of Surgery & Interventional Science
Faculty of Medical Sciences, University College London
132 Hampstead Road
London
NW1 2BX
England
United Kingdom

+44 (0)20 7679 9280
CTG.CTG@ucl.ac.uk
www.ucl.ac.uk/ctg
ROR logo https://ror.org/02jx3x895

Funders

Funder type

Charity

Prostate Cancer UK
Private sector organisation / Other non-profit organizations
Alternative name(s)
Prostate Cancer, Prostate Action, ProstateUK, prostatecanceruk
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPresentations 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
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No

Editorial Notes

20/09/2016: Internal review

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