Prostate cancer Cancer Malignant neoplasm of prostate
Conditions
Interventions
Participants will each be randomly allocated to one of two physical activity interventions, and one of three nutritional interventions. Men will be asked to follow their allocated interventions for si
Sponsors
University of Bristol (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Localised prostate cancer 2. To be undergoing radical prostatectomy 3. Be due to receive treatment at the Urology Centre, Southmead Hopsital, North Bristol NHS Trust 4. Capacity to consent for themselves as judged by a member of the research team with appropriate training and experience 5. Be aged 18 or over, there is no upper age limit 6. Have sufficient understanding of the English language, including being able to read and speak English at a basic level
Exclusion criteria
Exclusion criteria: 1. Inability to give informed consent or unavailability for follow-up 2. Being identified as unsuitable to participate following guidance of their clinician 3. Co-morbidities which could prevent participation in the intervention (RCT only) ie. this could include uncontrolled congestive heart failure or angina, recent myocardial infarction or breathing difficulties requiring oxygen use or hospitalisation. Additionally, the use of a mobility aid other than a walking stick 4. Allergies which would prevent participation in the intervention (RCT only) ie. allergy to lycopene 5. Religious beliefs that constrain them from participating in any aspect of the intervention (RCT only) 6. Any other additional reason for not being able to participate in any aspect of the intervention (RCT only) 7. Current heavy consumers of the nutritional element of the intervention, as judged by the research team (RCT only) ie. those who have been taking lycopene supplements daily for more than three months or eat more than five portions of fruit and vegetables every single day 8. Those who routinely exercise vigorously may not be suitable for the intervention (RCT only)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. As a feasibility trial, the dual primary outcomes will be randomisation rates and adherence to the intervention at six months following randomisation 2. Randomisation rates will be calculated as the proportion of eligible men, who agree to be randomised 3. Adherence to the intervention arms will be calculated independently for the two levels i.e. nutrition and physical activity 4. Adherence to the nutrition intervention will be assessed by analysis of mean serum, plasma or tissue levels, collected at cohort baseline, true trial baseline and 6 months post randomisation. Self-reported nutritional data will also be collected 5. Adherence to the physical activity intervention will be assessed via daily step count, recorded by pedometer and reported by the participants during the 6 month intervention phase. Self-reported physical activity data will also be collected | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Intervention tolerability (qualitatively collected data, reporting of adverse events) 2. Trial retention (number of participants successfully followed-up at the end of the 6 month trial, as a proportion of those who we recruited to the trial and randomised into a study arm at the start of the trial) 3. Change in prostate specific antigen (PSA) level (Change in participants absolute PSA level, from randomisation to 6 month follow up, collected via blood sample) 4. Change in insulin-like growth factor I (IGF-I) (Change in participants IGF-I, from randomisation to 6 month follow up, collected via blood sample) 5. Change in general nutrition (self-reported at baseline, 3 and 6 months, food frequency questionnaire (FFQ), Willett et al, 1985) 6. Change in general physical activity levels (self-reported at baseline, 3 and 6 months, Recent Physical Activity Questionnaire, Besson et al, 2010, accelerometers worn for two one week periods at cohort baseline and 6 month follow up) 7. Acceptability and ease of use of accelerometer (self-reported) 8. Urinary symptoms (collected at cohort baseline, true trial baseline, 3 and 6 month follow up, International Continence Society male - Short Form, (ICSmale-SF), Donovan et al., 2000) 9. Psychological factors (collected at cohort baseline, true trial baseline, 3 and 6 month follow up, Profile of Mood States - Short Form (POMS-SF), McNair et al, 1992 and Benefit Finding Scale, Antoni, 2001) 10. Health beliefs (collected at cohort baseline, true trial baseline, 3 and 6 month follow up, adapted from Prochaska & DiClemente, 1983; Ajzen, 1991) 11. Quality of life measures (collected at cohort baseline, true trial baseline, 3 and 6 month follow up, (Functional Assessment of Cancer Therapy - Prostate) FACT-P, Cella, 1997) 12. General health data (collected at cohort | — |
Countries
England, United Kingdom
Outcome results
None listed