Urothelial Carcinoma (UC)UrolifeNCT06982794
A Patient-Directed Mobile Tool to Streamline the QoL Assessment and Monitoring in Urothelial Carcinoma
An observational study of Urothelial Carcinoma (UC), run by IRCCS San Raffaele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma (UC)
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jun 2025to 31 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- not possession of a mobile device,
- unwillingness to give informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Raffaele
Milan, Italy, 20132
Brigida A Maiorano, MD, PhD, +390226435860, maiorano.brigida@hsr.it
About this study
Official title: 'UROLIFE': 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.
- Conditions
- Urothelial Carcinoma (UC)
- Keywords
- Quality of life, Self-education, Educational, Urothelial carcinoma, Web-app, Mobile tool, Design-thinking
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
eHealth Literacy Scale Score
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start30 Jun 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial Carcinoma (UC)Studies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brigida Anna Maiorano, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982794
- Sponsor's protocol ID
- URO-B01-step1
- Acronym
- Urolife
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be used only for publication in an aggregate form, and to build a web app. A subsequent phase of the project will be submitted, including the full version of IPD and their sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'UROLIFE': a Patient-Directed Mobile Tool to Streamline the QoL Assessment and Monitoring in Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT06982794
- Acronym / sponsor ID
- Urolife / URO-B01-step1
- Conditions
- Urothelial Carcinoma (UC)
- Keywords
- Quality of life, Self-education, Educational, Urothelial carcinoma, Web-app, Mobile tool, Design-thinking
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (2 listed)
- not possession of a mobile device,
- unwillingness to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
eHealth Literacy Scale Score
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: Undecided. Data will be used only for publication in an aggregate form, and to build a web app. A subsequent phase of the project will be submitted, including the full version of IPD and their sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Carcinoma (UC), run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation score for the Web App contents (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.