Research question | Outcome | Data collection method/tool | Time point of measurement | Â | Analysis plan | ||
---|---|---|---|---|---|---|---|
Baseline (T0) | During intervention | Post (T1) | 3-month FU (T2) | Â | |||
1. Can individuals with prostate/breast cancer be recruited into an e-cycling trial? | • No. of individuals in clinic; no. of meeting eligibility criteria; no. of express interest in participating • Reasons for not wanting to participate in the study • No. of individuals that consent to be part of the study | Study records | X |  |  |  | Frequencies and percentages |
2. Are participants’ willing to be randomised, do they remain in the study and adhere to the intervention and data collection methods and what are the rates of harmful events? | • No. of participants retained in study following randomisation • No. of individuals that complete follow-up testing • No. of participants that attend each of the intervention sessions and data collection sessions • No. of harmful events | Study records |  | X |  |  | Frequencies and percentages |
3. Can the intervention be implemented as intended? | • No. of training sessions attended by participants and additional contact with instructors • Extent to which intervention content is completed as planned • No. of and extent of adaptations | Intervention checklists |  | X |  |  | Frequencies and percentages |
4. Are the intervention and study procedures acceptable to participants, instructors and clinical team? | • Acceptability of recruitment strategy to clinical team • Acceptability of intervention to participants • Acceptability of study procedures to participants • Acceptability of intervention delivery to instructors | Semi-structured interviews |  |  | X |  | Thematic analysis based on research question |
5. What are participants experiences of e-cycling? | • Experiences of e-cycling • Participant’s barriers and facilitators to e-cycling | Semi-structured interviews |  |  | X |  | Thematic analysis based on research question |
6. What is the potential effect of the intervention on a range of individual health and behavioural outcomes? | • Weight, BMI and waist circumference | Tanita digital scales, SECA 700, non-stretch take | X |  | X | X | Comparison of change scores between conditions Reporting of effect estimates with 95% CI |
• Metabolic markers (fasting glucose, insulin, insulin resistance, lipid profile, IGF-I, IGF-II, IGFBP-2, IGFBP-3, PSAa) | 8-mL blood sample | X |  | X |  | ||
• General health-related quality of life | EuroQol-5 dimension-5 level | X |  | X | X | ||
• Cancer-specific quality of life | EORTC QLQ-C30 EORTC PR-25a EORTC BR-45b | X |  | X | X | ||
• Urinary healtha | ICIQ-MLUTS | X |  | X | X | ||
• Erectile dysfunctiona | International Index of Erectile Function | X |  | X | X | ||
• Fatigue | FACIT-F | X |  | X | X | ||
• Self-efficacy for coping with cancer | Cancer Behaviour Inventory — Brief | X |  | X | X | ||
• Cardiorespiratory fitness | Maximum oxygen uptake using cycle ergometer | X |  | X | X | ||
• Hand grip strength | Hydraulic hand dynamometer | X |  | X | X | ||
• Total physical activity (time spent in moderate-to-vigorous physical activity) | Axivity AX3 | X |  | X | X | Comparison of change scores between conditions | |
• Travel behaviour • No. of trips • Transport mode (walking, cycling, e-cycling, car, bus, train) • Trip purpose | QStarz GPS and travel diary | X |  | X | X | Mean and SD | |
• E-cycling behaviour and intensity: no. of journeys, duration, distance travelled, purpose of use | Bike odometer, Fitbit Charge 5 GPS watch, logbook |  | X |  |  | Mean and SD |