Bladder cancer Cancer
Conditions
Interventions
This is an observational, non-interventional cohort study to monitor social activity, physical activity, heart rate, weight, temperature, and sleep of bladder cancer patients receiving care at Amsterd
Sponsors
Amsterdam University Medical Centers
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Able to provide written informed consent 2. Patients suspected of or with a pathologically confirmed diagnosis of bladder cancer, with a predominant type of urothelial carcinoma or squamous cell carcinoma 2.1. Before or after undergoing TURBT 2.1. Before starting the rest of their treatment 3. = 18 years at screening 4. Can communicate well in Dutch with the investigator and willing to comply with the study instructions
Exclusion criteria
Exclusion criteria: 1. Permanent and temporary alterations on the wrist, including tattoos 2. Inability to wear or use wearables and other digital devices 3. Inability or limitations to walk or move at screening, or use of walking aids 4. History of allergy to surgical steel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following primary outcome measures are assessed to determine the feasibility of monitoring bladder cancer patients with the Trial@home platform: 1. Smartwatch wear-time measured using the amount of time (hours) in a complete day (24 hours) that the participant wears the Withings Steel HR smartwatch. This is calculated by the amount of time that the device registers a heart rate. Based on previously published feasibility studies, patients wearing the device for >50% of the observation period will be considered as feasible. 2. Compliance rates (questionnaires) measured using the EORTC QLQ-C30 and International Prostate Symptom Score (IPSS) questionnaires, defined as the completion of at least 90% of the total of questions. Compliance rates of ePRO vary widely in previous literature, from 60 to 97%. Based on these, for the electronic questionnaires (EORTC QLQ-C30 and IPSS) a compliance rate of at least 75% from the scheduled assessments, will be considered as feasible. 3. Compliance rates (Thermo) measured using compliance with daily temperature measurements, calculated by the number of completed temperature measurements divided by the total amount of days in the observation period. No cut-off points for feasibility have been established previously. The compliance rate with vital signs measurements varies between 72-85%. Therefore, a compliance rate of at least 75% will be considered as feasible. 4. Compliance rates (Body+) measured using compliance with weekly weight measurements, calculated by the number of completed weight measurements divided by the total amount of weeks in the observation period. To establish a cut-off point for feasibility, the same principle as for temperature will be applied (see previous point). Therefore, a compliance rate of at least 75% will be considered as feasible. 5. Compliance rates (Urinary frequency log) measured according to a weekly question regarding compliance: ‘How many times on average per day did you miss a registration t | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures are assessed to correlate social, physical, and physiological data of bladder cancer patients measured using data collected from the Trial@home platform for the duration of the study, the quality-of-life questionnaire (EORTC QLQ-C30) collected weekly and the performance status score: 1. Physical activity: step count, relative location 2. Social activity: 2.1. Phone usage (length of call, last 3 digits of phone number, number known/unknown) 2.2. App usage (categories of apps, start time, running in background/foreground) 2.3. Relative location 3. Weight (kg) 4. Body composition (%) 5. Temperature (°C) 6. Sleep pattern: sleep time, time in bed, sleep phases 7. Heart rate (beats per minute) 8. Urinary frequency (number of urinations per day and night) 9. EORTC QLQ-C30 scores 10. International Prostate Symptom Score 11. Treatment and dosing days 12. Number of treatment interruptions (and reason) 13. Number of emergency room visits (and reason) 14. Number of planned and unplanned hospitalizations (and reason, date, length) 15. Adverse events 16. Performance status (ECOG) 17. Radiological evaluations (and date) | — |
Countries
Netherlands
Contacts
Public ContactDominique Stuijt
Outcome results
None listed