Prostate cancer Cancer Malignant neoplasm of prostate
Conditions
Interventions
A randomized pilot study will be conducted and will consist of two trial arms: 1) an e-biking intervention and 2) a waitlist control (no intervention). While the primary aim of this study is to examin
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men with high-risk localised prostate cancer (PSA >20 or clinical stage =cT2c or Gleason 8/9/10 (NICE Guidance definition)), OR men with locally advanced prostate cancer (in addition to the above, T3b and T4, N0 prostate cancer; and any T, N1 prostate cancer), OR men with metastatic prostate cancer (stage M1) 2. Aged 18 years or over 3. Cleared for engaging in physical activity by the treating consultant For the instructor/coordinator interviews the inclusion criterion is that individuals have coordinated the CRANK project or delivered e-bike training to participants in the CRANK trial. For healthcare professionals the inclusion criterion for participating in the interviews is that they have been involved in identifying and/or recruiting individuals for the CRANK-P trial.
Exclusion criteria
Exclusion criteria: 1. Engage in =150 minutes of moderate-to-vigorous physical activity per week 2. Uncontrolled hypertension (systolic blood pressure (BP) >160 mmHg and/or diastolic BP >90 mmHg), for which the individual is not taking medication 3. Comorbidities including myocardial infarction or stroke within the past 6 months or evidence of end-stage renal failure or liver disease, uncontrolled congestive heart failure or angina 4. Use of a mobility aid preventing cycling 5. No previous experience riding a bicycle 6. Any other contra-indications to exercise 7. Are unable to read and communicate in English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment, measured by the number of participants recruited by the end of the recruitment period 2. Retention rates, measured by retention of sample by the end of the intervention 3. Adherence to the intervention and data collection methods and the fidelity of intervention delivery measured through observation checklists during the study intervention period 4. Perceptions of the intervention for the deliverers, recruiters, and participants assessed with qualitative interviews after the study intervention 5. Safety or maintenance issues measured by recording incidents throughout the study intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| The pilot study will include the following clinically relevant secondary outcome measures, assessed at baseline, post-intervention and 3-month follow-up: 1. Anthropometric outcomes (BMI: weight measured using a digital scale, height measured using a stadiometer, waist circumference measured using a non-stretch tape measure) 2. Cardiometabolic outcomes including fasting glucose and insulin, prostate-specific antigen, insulin-like growth factor (IGF-1 and IGF-II), ICFBP-2 and IGFBP-3 obtained by venepuncture 3. Generic quality of life measured using the EuroQol-5 Dimension-5 level survey (EQ-5D-5L) 4. Cancer specific health-related quality of life measured using the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) 5. Urinary health measured using the International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS) 6. Erectile dysfunction measured using the International Index of Erectile Function (IIEF) 7. Fatigue measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) 8. Self-efficacy to cope with cancer measured using the Cancer Behaviour Inventory- Brief version (CBI-B) Physiological mechanistic outcomes assessed at baseline and post-intervention and 3-month follow-up: 1. Cardiorespiratory fitness measured using cardiopulmonary exercise testing (CPET); Ergoselect bicycle ergometer (Ergoselect 100, Love Medical, Manchester, UK). 2. Hand-grip strength measured using Jamar Hand Dynamometer (USA) Behavioural outcomes: 1. E-bike activity: number and duration of e-bike journeys per week (assessed throughout the intervention) assessed using the Fitbit Charge 5 worn during the study intervention period 2. Physical activity assessed using the Axivity AX3 wrist-worn triaxial accelerometer at baseline and during the final week of intervention and at 3-month follow-up 3. Travel behaviour: spatial location data collected using a personal | — |
Countries
England, United Kingdom
Outcome results
None listed