Prostate cancer Cancer Malignant neoplasm of prostate
Conditions
Interventions
Intervention 1: Usual care
Patients receiving the usual care intervention will continue to have their follow-up appointments (at the hospital or local GP practices), and will receive t
2. Exploring existing symptoms (e.g., incontinence, frequency, bowel problems, sexual dysfunction and fatigue), and the range of physical and emotional concerns regularly experienced by patients (see
3. Encouraging self-management and behavioural activation (e.g., setting goals, teaching pelvic floor exercises, bladder retraining techniques, weight loss and exercise management,
Sponsors
Bangor University (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed