An interventional study of Exercise in Prostate Cancer, sponsored by University of Surrey. Recruiting at 1 site in United Kingdom. Open to male participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-12-17.
Sponsored by University of Surrey · Not applicable, Interventional, and Supportive care
Currently, there are few opportunities for patients with cancer to have individual exercise guidance, and this has further been impacted by the Covid-19 pandemic. However, during the pandemic the use of virtual/remote platforms has been crucial in delivering care to cancer patients. The investigators think that remote exercise training may also offer a solution to support positive change in prostate cancer patients. As a result, the investigators have developed a remote/online exercise programme to explore this further.
This study will explore the effectiveness of an 8-week remote exercise and behavioural support intervention, and whether prostate cancer patients feel they benefit from this. The study also aims to see if this sort of exercise programme can be delivered to more prostate cancer patients in the future. This project is open to men with prostate cancer on long term hormone therapy. The intervention will be comprised of one remote supervised session per week, completed 1-1 using an online platform and up to two additional sessions, depending on its suitability for the patient, will be prescribed as unsupervised home-based exercise.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's planned enrollment of 50 is below the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University of Surrey is the lead sponsor of 91 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Exercise arm
Behavioral: Exercise
8 week exercise intervention, 3x/wk
Functional Assessment of Cancer Therapy-Prostate
Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. Twenty-seven questions about physical, social/family, emotional and functional well-being are graded from 0-4 (0 = not at all; 4 = very much), yielding a total between 0 and 108.
Time frame: t= 0, 4, 8, 16 & 30 weeks
Functional Assessment of Cancer Therapy
Functional Assessment of Cancer Therapy fatigue (FACIT-f) questionnaire. The FACIT-Fatigue is a validated questionnaire that was originally developed for the precise evaluation of fatigue levels in cancer patients with anemia. It consists of 13 questions using a 5 point scale (0=not at all; 1 = a little bit, 2 = somewhat, 3 = quite a bit and 4 = very much). It has been used frequently in the clinical trial setting (please see appendix 1). Responses to each question are added with equal weight to obtain a total score. The range of possible scores is 0-52, with 0 corresponding to the highest level of fatigue and 52 corresponding to the lowest level of fatigue.
Time frame: t= 0, 4, 8, 16 & 30 weeks
Leisure time physical activity
Godin Leisure Time Exercise Questionnaire. This is a 3 question self-report questionnaire - indirect measure of physical activity
Time frame: t= 0, 4, 8, 16 & 30 weeks
Physical activity
The Dukes Activity Status Index. The Duke Activity Status Index (DASI) is a 12-item questionnaire that utilized self-reported physical work capacity to estimate peak metabolic equivalents (METs).
Time frame: t= 0, 4, 8, 16 & 30 weeks
Cardiovascular risk
Qrisk3. Estimation of cardiovascular risk based on demographical and physiological parameters
Time frame: t= 0, 4, 8 weeks
Exercise adherence
Session adherence. The number of sessions attended, and % of scheduled sessions performed. Every exercise session either completed or not completed over the 8 week intervention period
Time frame: weekly for 8 weeks
Health status
eq-5d-5l. It comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels: no problems, slight problems, some problems, severe problems and unable to do. Each level of answer consists of each level of score ranges from 1 to 5. Each participant will have a health status consisting of 5 digits. Using the set of weights from Vietnamese population provided from the EuroGroup, we can convert each EQ-5D health state into a single summary index value. The index value ranges from 0 to 1, higher scores meaning better health quality.
Time frame: t= 0, 4, 8, 16 & 30 weeks
Plan to share: No — No de-identified data will be shared with other researchers to protect patient confidentiality
No publications or documents are linked to this record.
Started Apr 2024 (actual). Primary completion is estimated for Jun 2025, 14 months after the start.
Of 1,018 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 87. This study's planned 14 months is below that.
Counting every sponsor, half of 1,063 studies reached it within 45 months; a quarter within 22 and three quarters within 87.
How these figures are worked out, and which studies are left out of them.
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University of Surrey