Breast cancer survival Cancer
Conditions
Interventions
Sponsors
University of Bristol
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women with early breast cancer who have completed their primary breast cancer treatment (i.e., surgery, chemotherapy and/or radiation therapy) 2. Aged =18 years 3. Cleared for engaging in physical activity by the treating surgeon For the instructor/coordinator interviews the inclusion criteria is that individuals have coordinated the CRANK project or delivered e-bike training to participants in the CRANK trial. For health care professionals the inclusion criteria for participating in the interviews is that they have been involved in identifying and/or recruiting individuals for the CRANK-B trial.
Exclusion criteria
Exclusion criteria: 1. Engage in =150 minutes of moderate-to-vigorous physical activity per week 2. Individuals with metastatic disease 3. Uncontrolled hypertension (systolic blood pressure (BP) >160 mmHg and/or diastolic BP >90 mmHg), for which the individual is not taking medication 4. Comorbidities including myocardial infarction or stroke within the past six months or evidence of end-stage renal failure or liver disease, uncontrolled congestive heart failure or angina 5. Use of a mobility aid preventing cycling 6. No previous experience riding a bicycle 7. Any other contra-indications to exercise 8. 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, the fidelity of intervention delivery will be measured through observation checklists during the study intervention period 4. Perceptions of the intervention for the deliverers, recruiters, and participants through qualitative interviews after the study intervention 5. Safety or maintenance issues will be measured by record of incidents throughout the study intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Anthropometric outcomes including BMI calculated using weight measured using the digital scale, height measured using the stadiometer, and waist circumference measured using the non-stretch tape measure at baseline, post-intervention, and 3-month follow-up 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 measured from blood samples obtained by venipuncture at baseline, post-intervention, and 3-month follow-up 3. Generic quality of life measured using the EuroQol-5 Dimension-5 level survey (EQ-5D-5L) at baseline, post-intervention, and 3-month follow-up 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) at baseline, post-intervention, and 3-month follow-up 5. Fatigue measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at baseline, post-intervention, and 3-month follow-up 6. Self-efficacy to cope with cancer measured using the Cancer Behaviour Inventory- Brief version (CBI-B) at baseline, post-intervention, and 3-month follow-up 7. Cardiorespiratory fitness measured using Cardiopulmonary exercise testing (CPET) and the Ergoselect bicycle ergometer (Ergoselect 100, Love Medical, Manchester, UK) at baseline, post-intervention, and 3-month follow-up 8. Hand-grip strength measured using Jamar Hand Dynamometer (USA) at baseline, post-intervention, and 3-month follow-up 9. E-bike activity measured using the 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 10. Physical activity measured using the Axivity AX3 wrist-worn triaxial accelerometer at baseline and during the final week of intervention, and at 3-month follow-up 11. Travel behaviour measured using the spatial location data will be c | — |
Countries
England, United Kingdom
Outcome results
None listed