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

NCT06982794 | Recruiting

• 1 other identifier: URO-B01-step1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Urothelial Carcinoma (UC)

Keywords

Quality of life; Self-education; Educational; Urothelial carcinoma; Web-app; Mobile tool; Design-thinking

Outcome Measures

Primary Outcomes (1)

• Evaluation score for the Web App contents

  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.

  3 months

Secondary Outcomes (1)

• eHealth Literacy Scale Score

  3 months

Study Arms (1)

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

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of urothelial carcinoma and candidate to receive systemic treatments at the Ospedale San Raffaele Department of Medical Oncology, Milan (Italy).

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele

Milan, Italy, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Medical Oncology

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 21, 2025
• Study Start: June 30, 2025
• Primary Completion: September 30, 2025
• Study Completion: October 31, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

IT (1)