An observational, non-interventional cohort study to monitor physical and social activity of bladder cancer patients during treatment with curative intent by using conventional and digital methodology

Recruiting

• Conditions: Bladder cancer; 10038364; 10004994

• Registration Number: NL-OMON51316
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1. Able to provide written informed consent.
2. Patients suspected of or with pathologically confirmed diagnosis of bladder
cancer, with as predominant type urothelial carcinoma or squamous cell
carcinoma.
a. Before or after undergoing TURBT.
b. Before starting the rest of their treatment.
3. >= 18 years at screening.
4. Has the ability to communicate well in Dutch with the investigator and
willing to comply with the study instructions.

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.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Smartwatch wear-time<br /><br>• Compliance rates<br /><br>• Adverse device effects</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Parameters collected from Trial@home<br /><br>• EORTC QLQ-C30 questionnaire<br /><br>• Performance status score</p><br>