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

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.

1. Patient attrition rate: calculated from the number of patients who will have given their consent to take part in the trial, and the number of patients who have submitted any of the intervention outcome and health service use measures (see below) taken at the end of the intervention, regardless of their completion rate. This is calculated after follow-up, at the end of the trial.
2. Intervention outcome measures: Two measures will be taken: at baseline and after follow-up (at the end of the trial - at 9 months). The following questionnaires, collated in a single booklet, and consisting exclusively of validated clinical measures will be administered (before and after the 9 months intervention) to assess:
2.1. Prostate cancer specific follow-up symptoms (EPIC-26, Expanded Prostate Cancer Index Composite - 26; Szymanski et al., 2010)
2.2. Confidence in managing own health (Lorig et al., 2001)
2.3. Medical and support needs (Supportive Care Needs Survey - simplified response format; Schofield et al., 2011)
2.4. General health and quality of life (EQ-5D-5L; Brooks, 1996)
2.5. ICECAP-A (Al-Janabi, Keeley, Mitchell, Coast, 2013)
2.6. Psychological wellbeing (Hospital Anxiety and Depression Scale; Zigmond and Snaith, 1983)
3. Health Service Use Measure: This will be taken three times during the trial: at 3, 6, and 9 months (end of the trial). The usage of health and social care services will be measured at 3, 6 and 9 months after the start of the intervention. The purpose-built questionnaire/diary - a client service receipt inventory (CSRI) (Ridyard & Hughes, 2010) will be used to measure, from a societal perspective, frequency and types of contacts with primary and secondary healthcare services and social services. We will also note contacts with voluntary sector services. The CSRI will include information about:
3.1. The number of times the patients had to see a doctor, nurse, or other healthcare professional in relation to his prostate cancer related symptoms.
3.2. The special medication, aids, and adaptations prescribed to patients to help with their prostate cancer related symptoms.
3.3. The number of days patients felt too unwell to participate in their normal activities due to prostate cancer related symptoms.
4. Relevant Medical History Data: Patient diagnosis, cancer stage, treatment, comorbidities and other relevant medical history data will be collected from GP-and hospital-held records with patients' consent. This will be collected after follow-up (at the end of the trial), from patients' medical records.
5. Feedback interviews: The experiences and views of a sub-sample of patients in the intervention group (n=32), the research nurse (CNS-R), and secondary and primary card Clinicians (n=10) in charge of the patients' usual follow-up care will be sought in the feedback interviews. Patients will be randomly selected from those who have given their consent to take part in the feedback process. Interviews will take place after follow-up (at the end of the trial).