ifestyle intervention in men with advanced prostate cancer receiving androgen suppression therapy
- Conditions
- Men with advanced prostate cancer receiving androgen suppression therapyCancerMalignant neoplasm of prostate
- Registration Number
- ISRCTN88605738
- Lead Sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 100
1. Histologically confirmed, non-localised prostate cancer (PCa)
2. Stable disease (stable prostate specific antigen [PSA])
3. Receiving Androgen suppression therapy (AST) for a minimum period of six months
4. A willingness to comply with the randomised allocation to intervention and willing to undertake the requirements of the allocated intervention. If allocated to the exercise intervention, willing to aim to achieve 80% compliance to the exercise intervention.
1. Participation in regular physical activity (defined as purposeful physical activity of a moderate intensity for 30 minutes three or more times per week in the previous six months)
2. Unstable angina, uncontrolled hypertension, recent myocardial infarction, pacemakers
3. Uncontrolled painful or unstable bone lesions
4. Less than two months post surgical treatment
5. Any physical, neurological or psychiatric impairment or disease such as dementia, multiple sclerosis, severe arthritis or other condition that would limit the ability to understand and complete the study exercises and complete the required questionnaires, recall and record of dietary information
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Current primary outcome measures as of 12/07/2013:<br>To be measured at baseline, 12 and 26 weeks:<br>1. Quality of life measured using the FACTP questionnaire<br>2. Diastolic blood pressure measured using an automated sphygmomanometer<br><br>Previous primary outcome measures:<br>1. Exercise behaviour measured using the Godin Leisure Score Index questionnaire at baseline, 12 weeks and 6 months of follow-up<br>2. Dietary intake measured using three day diet diaries over the intervention period
- Secondary Outcome Measures
Name Time Method