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

San Donato Group (GSD)

Status: Enrolling

Conditions: Urothelial Carcinoma (UC)

Study type: Observational

Funder types: Other

Identifiers

NCT06982794

URO-B01-step1

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Patients with urothelial carcinoma candidate to receive systemic therapy, having a mobile device

Description:

Patients will receive a researcher-made questionnaire to gather the demographic and clinical characteristics of the respondents (age, sex, educational level, employment status, type of treatment for UC, physical activity, familiarity and caregiver status, interest, and comfortability with mobile devices and apps). Paper questionnaires containing the main contents to be included in the future development of the 'Urolife' web-app will be presented. Four categories of educational and self-management contents will be proposed: 1. Quality of life questionnaires; 2. Self-education on symptoms and AEs tool; 3. Links to verified patients' forums and support organizations for UC; 4. Educational videos and podcasts. Patients will have the opportunity to propose other useful tools. Each tool will be rated by the patients. User needs will be elicited through co-creation sessions held with the Design Thinking method.