TOPCAT-P: a pilot study to determine the feasibility of a nurse-led intervention for improving the symptoms of men recovering from prostate cancer

Not Applicable

Completed

• Conditions: Prostate cancer; Cancer; Malignant neoplasm of prostate

• Registration Number: ISRCTN34516019
• Lead Sponsor: Bangor University (UK)

Brief Summary

1. 2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26112224 2. 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/30478975 (added 25/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-20
• Study Completion: 2015-07-31
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

1. Stable, incident prostate cancer patients in BCUHB (defined as being 9-24 months post-diagnosis) in NE Wales
2. Considered fit for taking part in the trial, as assessed by their multi-disciplinary team (MDT)
3. Having undertaken radical curative therapy for prostate cancer (surgery, radiotherapy, or brachytherapy), or being followed up with PSA monitoring and symptom reporting (watchful waiting)
4. All patients will have the ability to give informed consent, as assessed by the MDT

Exclusion Criteria

1. Men who are in the Active Surveillance group (men who are suitable for active treatment, but choose to be monitored until proof of progression)
2. Men who are clearly in the palliative phase
3. Men who are deemed to be unable to take part in the trial (e.g., severe learning disability)
4. Men who have active symptoms of severe enduring mental health problems, preventing patients from successfully participating in research studies (as assessed by the MDT)
5. Men who do not have capacity to give informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary measure of the pilot trial will be the patient recruitment rate. This will be calculated from the total number of patients contacted with the invitation to take part in the study and the number of patient giving their written consent to taking part in the trial. This is calculated at baseline, before the start of the trial.