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

NCT ID: NCT06982794

Last Updated: 2025-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-30

Study Completion Date

2025-10-31

Brief Summary

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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

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Conditions

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Urothelial Carcinoma (UC)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Brigida Anna Maiorano

Principal Investigator, Department of Medical Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS San Raffaele

Milan, Italy, Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Brigida A Maiorano, MD, PhD

Role: primary

+390226435860

Other Identifiers

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URO-B01-step1

Identifier Type: -

Identifier Source: org_study_id

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