A Patient-Directed Mobile Tool to Streamline the QoL Assessment and Monitoring in Urothelial Carcinoma

Recruiting

• Conditions: Urothelial Carcinoma (UC)

• Registration Number: NCT06982794
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

The goal of this observational study is to select contents and tools for the future development of a web app aiming to support patients' navigation for empowering decision-making through a higher awareness of urothelial carcinoma and its treatments, improving also educational aspects.

The main question it aims to answer is:

What are the contents that patients diagnosed with urothelial carcinoma find useful to include in a web app to streamline their quality of life assessment and monitoring?

Participants candidate for systemic treatments, or already under treatment, will answer questionnaires about the tools to include in a web app designed for urothelial carcinoma.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-05
• Study First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21
• Study Start: 2025-06-30
• Primary Completion: 2025-09-30
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• histological diagnosis of urothelial carcinoma;
• ≥ 18 years old,
• candidate for systemic treatment with chemotherapy, immune-checkpoint inhibitors, antibody-drug conjugates, or target therapy (patients can be enrolled also if the treatment has started),
• possession of a mobile device (e.g., smartphone or personal computer) with the physical and psychological ability to use mobile devices,
• understanding and speaking the Italian language,
• ability to sign an informed consent.

Exclusion Criteria

• not possession of a mobile device,
• unwillingness to give informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation score for the Web App contents	3 months	A paper questionnaire will be administered to the participants. Each question will regard the description of the tool, with functions and characteristics, to be included in the Web App: 1. Quality of life questionnaires; 2. Self-education on symptoms and adverse events tool; 3. Links to verified patients' forums and support organizations for UC; 4. Educational videos and podcasts. Each section will receive an evaluation of 0 (not interesting), 1 (of moderate interest), or 2 (very interesting). A total score of the questionnaires will determine patients' interest in the different contents. A final free-text section will be given for further patients' purposes not included in the main questionnaire.

Secondary Outcome Measures

Name	Time	Method
eHealth Literacy Scale Score	3 months	The eHEALS is an 8-item measure of eHealth literacy developed to measure consumers' combined knowledge, comfort, and perceived skills about the use of mobile device. Each patient will be required to complete the paper questionnaire, and final scores for each questions will be recorded.

Trial Locations

Locations (1)

IRCCS San Raffaele; 🇮🇹 Milan, Italy