Supported exercise TrAining for Men wIth prostate caNcer on Androgen deprivation therapy - the STAMINA programme

Sheffield Teaching Hospitals NHS Foundation Trust0 个研究点目标入组 697 人开始时间: 2020年7月30日最近更新: 2024年9月9日

适应症

试验速览

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38610058/ (added 15/04/2024) 2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/39223607/ Process evaluation workshop data (added 03/09/2024)

•1. Men with prostate cancer on ADT or due to start ADT within the next twelve weeks
•2. Willing and able to provide informed consent

•Current exclusion criteria as of 06/10/2021:
•1. Absolute contraindication to exercise as defined by clinical guidance e.g. ACPICR standards
•2. Uncontrolled hypertension
•3. Uncontrolled diabetes mellitus
•4. Recent myocardial infarction (within past 6 months)
•5. Unable to provide informed consent (e.g. lack of capacity)
•6. Unstable bony metastases unresponsive to treatment
•7. Unable to complete study assessments
•8. Participation in other lifestyle intervention trial for PCa
•9. Estimated life expectancy of less than 12 months for reasons unrelated to PCa diagnosis
•10. Involvement in previous STAMINA work packages or PPI panel
•Previous exclusion criteria:
•1. Proven metastatic castrate-resistant prostate cancer (mCRPC) on imaging
•2. Unstable angina
•3. Uncontrolled hypertension and/or diabetes mellitus
•4. Recent myocardial infarction (within past 6 months)
•5. Unable to provide informed consent (e.g. lacking capacity)
•6. Painful or unstable bony metastases
•7. Inability to read or speak English to an appropriate level is an exclusion criteria, to ensure safe compliance with the exercise programme
•8. Fixed output pacemakers
•9. Any other absolute contraindication to exercise as defined by clinical guidance, e.g. ACPICR standards
•10. Unable to complete study assessments
•11. Participation in other lifestyle intervention trials for PCa
•12. Estimated life expectancy of less than 12 months for reasons unrelated to PCa diagnosis

发起方