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NCT Number: NCT06982794

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

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.

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Key information

Conditions

Urothelial Carcinoma (UC) Carcinoma Carcinoma, Transitional Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Evaluation score for the Web App contents

    Time frame: 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 outcomes

  1. eHealth Literacy Scale Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

'UROLIFE': a Patient-Directed Mobile Tool to Streamline the QoL Assessment and Monitoring in Urothelial Carcinoma

Acronym: Urolife

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 21, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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