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

True NTH UK post surgical follow up: development and evaluation of a patient-reported instrument to monitor oncological and functional outcomes after radical prostatectomy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN13511717

Enrollment

1000

Registered

2015-11-23

Start date

2015-11-13

Completion date

Unknown

Last updated

2016-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer Cancer

Interventions

Radical prostatectomy

Eligibility

Sex/Gender

Male

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Men who are unable to give informed consent.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
There are no secondary outcome measures.	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026