Condition category
Cancer
Date applied
06/11/2015
Date assigned
23/11/2015
Last edited
24/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

www.ucl.ac.uk/ctg

Funders

Funder type

Charity

Funder name

Prostate Cancer UK

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

20/09/2016: Internal review