17 Also, patients perceive they receive more care from the general practitioner (GP), 18 while their quality of life remains similar between hospital and primary care follow-up. Early initiatives showed that by involving primary and community care, the utilisation of specialist care may be reduced, especially for the more elderly patients. In the last decade and a half, attempts have been made to address the lack of empirical evidence regarding the efficacy and cost-effectiveness of prostate cancer follow-up. 16 However, recommendations on the type of follow-up to be undertaken are notably missing from the guidelines. 15 In the absence of reliable empirical evidence, the National Institute for Health and Care Excellence (NICE) guidelines recommend that unless significant treatment complications develop, after 2 years, their follow-up care should take place out of hospital. 14 However, current practice is not underpinned by robust evidence, and is notoriously variable between hospitals. Patients with prostate cancer are normally followed up in out-patient clinics in hospital for up to 5 years, to monitor and manage the risk of recurrence, and the physical symptoms following treatment.
13 Thus, the assessment and management of the adverse treatment effects, related psychosocial needs (also affecting their partners) and the impact on the management of other comorbid conditions is, for many patients, complex and prolonged. 9 The diagnosis and treatment toxicities also affect the patients' immediate families, 10 particularly through psychological distress related to anxiety, depression 11, 12 and psychosexual problems. 6–8 Psychological distress is also significant, and most prostate cancer survivors require prompt information about treatment outcomes and its impact on daily living. 5 The management of chronic comorbid conditions (eg, cardiovascular disease and cerebrovascular disease, hypertension, diabetes) often further increases the level of need, and about two-thirds of patients with prostate cancer are expected to have at least one major comorbidity. 1, 2 Common physical symptoms are related to sexual function, urinary incontinence, 3 bowel symptoms, 4 hot flushes and the risk of bone fracture. Over the past 20 years, in the UK, incidence rates have doubled, but mortality rates have dropped by a quarter. Prostate cancer is the most common cancer for men in the UK (second worldwide), and many survivors experience long-lasting physical and psychological needs.
#Topcat manual trial
Recruitment, attrition, questionnaire completion rates and outcome measures variability will be assessed, and results will inform the design of a future phase III trial and accompanying economic evaluation. Feedback interviews with patients and clinicians will further inform the acceptability of the intervention.
Healthcare service use will be measured over 36 weeks. Outcome measures will assess physical symptoms, psychological well-being, confidence in managing own health and quality of life. Following the health policy in Wales, the intervention is offered by a key worker, is promoting prudent healthcare and is using a holistic needs assessment. We will recruit 120 patients who will be randomised to receive either an augmented form of usual care, or an additional nurse-led intervention for a period of 36 weeks. Eligible men would have either completed radical treatment, or would be followed up with prostate specific antigen monitoring and symptom reporting. Methods and analysis Prostate cancer survivors diagnosed in the past 9–48 months and currently biochemically stable will be identified from hospital records by their treating clinician.
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