Prostate CancerNCT06955910
Assessing Financial Toxicity Using the PROFFIT Questionnaire in Patients Treated With Mini-invasive Approach for Urological Malignancies.
An observational study of Prostate Cancer and Bladder Cancer, run by Istituto Oncologico Veneto IRCCS at 1 site in Italy.
Trial summary
Patients previously treated with robotic surgery for urological cancers such as prostate, bladder and kidney cancer will be enrolled, in particular patients operated in the last twelve months will be included after signing the informed consent. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Prostate Cancer, Bladder Cancer, Kidney Cancer
- What is being tested?
- questionnaires
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 18 Jun 2025to 13 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- Adult, Older adult
Study population: It is planned that the study will enroll about 120 Patients. In particular, patients with urological tumors who underwent minimally invasive surgery, using a robotic approach, in the last twelve months, will be enrolled.
Who may be able to join
- Male or female ≥ 18 years of age;
- ECOG PS 0-1
- Diagnosis of urological neoplasm (prostate, bladder and kidney cancer) treated with robotic surgery (robot-assisted prostatectomy, robot-assisted radical cystectomy, robot-assisted radical or partial nephrectomy) in the last twelve months;
- Subjects willing to sign informed consent.
Who cannot join
- Patients unable to fill out questionnaires (e.g., severe mental illness or cognitive dysfunction);
- Patients suffering from concomitant malignancies in other sites and in active treatment;
- Patients with a history of cancer not currently on active treatment may be enrolled.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing Financial Toxicity Using the PROFFIT Questionnaire in Patients Treated With Mini-invasive Approach for Urological Malignancies. UROFIT Study.
Patients previously treated with robotic surgery for urological cancers such as prostate, bladder and kidney cancer will be enrolled, in particular patients operated in the last twelve months will be included after signing the informed consent.
Within 12 months after mini-invasive procedure, subjects are identified, contacted by phone/email, or invited to attend during the regular scheduled follow-up visit. If this is not possible, patients will be asked to schedule a special interview to assess possible participation in the study. During follow-up or unscheduled visit, the subsequent information will be collected through a questionnaire that contains several socio-demographic and anamnestic questions.
Read more
During subsequent visit, PROFFIT and EORTC QLQ-C30 questionnaires will be administered to patients. Post-operative complications are reported using the Clavien-Dindo classification.
Anamnestic and socio-demographic information will be collected through a generic self-designed questionnaire including the following data: age, sex, residence (within or outside the Veneto region), marital status (married, divorced, cohabiting, single, widowed), employment status (employed, unemployed, retired), presence of dependents (yes/no), level of education (defined as primary, middle or high school, university degree), concomitant pathologies.
Additional data on the oncological history are also reported: histology and staging of the disease, presence or absence of metastatic disease, additional treatments before or after surgery (e.g. neoadjuvant treatments, adjuvant treatments, radiotherapy).
Read the detailed description
The rationale behind the design of this study is to define a snapshot of the impact of robotic surgery performed in uro-oncology patients on financial toxicity assessed through PROFFIT questionnaire. The design of a cross-sectional study allows to define whether minimally invasive surgical treatment can impact financial toxicity in a cohort of patients previously treated with minimally invasive surgery (which may differ for additional treatments received, ease of access to medical care secondary to place of residence/domicile, level of education, employment and family status).
- Conditions
- Prostate Cancer, Bladder Cancer, Kidney Cancer
- Being tested
- questionnaires
- Keywords
- financial toxicity, PROFFIT questionnaire, robotic surgery, urological tumors, Prostate Cancer, Bladder Cancer, Kidney Cancer
- Medical subject headings
- Prostatic Neoplasms, Urinary Bladder Neoplasms, Kidney Neoplasms, Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
Anamnestic and socio-demographic information will be collected through a generic self-designed questionnaire including the following data: age, sex, residence (within or outside the Veneto region), marital status (married, divorced, cohabiting, single, widowed), employment status (employed, unemployed, retired), presence of dependents (yes/no), level of education (defined as primary, middle or high school, university degree), concomitant pathologies.
Additional data on the oncological history are also reported: histology and staging of the disease, presence or absence of metastatic disease, additional treatments before or after surgery (e.g. neoadjuvant treatments, adjuvant treatments, radiotherapy).
| Study group | Role | What they receive |
|---|---|---|
| PROFFIT and EORTC QLQ-C30 questionnaires | Not described Receives: Other: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective and end point
Assess financial toxicity using the PROFFIT questionnaire in patients treated with robotic surgery for urological tumors. The PROFFIT questionnaire comprises the financial toxicity score (composed of the first 7 items) plus 9 other individual items indicating the possible determinants of financial difficulties. These items cover three main areas, such as medical expenses (items 8 to 11), transportation (items 12 and 13), and support for medical/health personnel (items 14 to 16).
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Secondary Objective and end point
Evaluate factors associated to increased financial toxicity. Evaluation of the correlation between subjects' demographic characteristics and Financial Toxicity score (first 7 items)
Measured: Through study completion, an average of 1 year
Secondary Objective and end point
Explore the correlation between financial toxicity and the impact on patients' quality of life. The EORTC QLQ-C30 questionnaire will be used to assess the patient's quality of life. This questionnaire has solid psychometric properties deriving from its use in several international clinical trials on cancer. Item Q28 and items Q29-30, the latter expressed according to "health status/quality of life scale" (HR-QoL), will be correlated with the FT score to assess the impact of financial toxicity on quality of life.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start18 Jun 2025
- Primary completion13 Apr 2026
- Study completion13 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Oncologico Veneto IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955910
- Sponsor's protocol ID
- IOV-UC-01-2025-UROFIT
- Status last verified
- Jul 2026
- First submitted
- 16 Apr 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Financial Toxicity Using the PROFFIT Questionnaire in Patients Treated With Mini-invasive Approach for Urological Malignancies. UROFIT Study.
- ClinicalTrials.gov ID
- NCT06955910
- Acronym / sponsor ID
- IOV-UC-01-2025-UROFIT
- Conditions
- Prostate Cancer, Bladder Cancer, Kidney Cancer
- Keywords
- financial toxicity, PROFFIT questionnaire, robotic surgery, urological tumors, Prostate Cancer, Bladder Cancer, Kidney Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Istituto Oncologico Veneto IRCCSUniversity, hospital or other
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 13 Apr 2026 (actual)
- Study completion
- 13 Apr 2026 (actual)
- First posted
- 2 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.
Patients previously treated with robotic surgery for urological cancers such as prostate, bladder and kidney cancer will be enrolled, in particular patients operated in the last twelve months will be included after signing the informed consent.
Within 12 months after mini-invasive procedure, subjects are identified, contacted by phone/email, or invited to attend during the regular scheduled follow-up visit. If this is not possible, patients will be asked to schedule a special interview to assess possible participation in the study. During follow-up or unscheduled visit, the subsequent information will be collected through a questionnaire that contains several socio-demographic and anamnestic questions.
During subsequent visit, PROFFIT and EORTC QLQ-C30 questionnaires will be administered to patients. Post-operative complications are reported using the Clavien-Dindo classification.
Anamnestic and socio-demographic information will be collected through a generic self-designed questionnaire including the following data: age, sex, residence (within or outside the Veneto region), marital status (married, divorced, cohabiting, single, widowed), employment status (employed, unemployed, retired), presence of dependents (yes/no), level of education (defined as primary, middle or high school, university degree), concomitant pathologies.
Additional data on the oncological history are also reported: histology and staging of the disease, presence or absence of metastatic disease, additional treatments before or after surgery (e.g. neoadjuvant treatments, adjuvant treatments, radiotherapy).
Detailed description
The rationale behind the design of this study is to define a snapshot of the impact of robotic surgery performed in uro-oncology patients on financial toxicity assessed through PROFFIT questionnaire. The design of a cross-sectional study allows to define whether minimally invasive surgical treatment can impact financial toxicity in a cohort of patients previously treated with minimally invasive surgery (which may differ for additional treatments received, ease of access to medical care secondary to place of residence/domicile, level of education, employment and family status).
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PROFFIT and EORTC QLQ-C30 questionnaires | – | Other: questionnaires |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- It is planned that the study will enroll about 120 Patients. In particular, patients with urological tumors who underwent minimally invasive surgery, using a robotic approach, in the last twelve months, will be enrolled.
Key inclusion criteria (4 listed)
- Male or female ≥ 18 years of age;
- ECOG PS 0-1
- Diagnosis of urological neoplasm (prostate, bladder and kidney cancer) treated with robotic surgery (robot-assisted prostatectomy, robot-assisted radical cystectomy, robot-assisted radical or partial nephrectomy) in the last twelve months;
- Subjects willing to sign informed consent.
Key exclusion criteria (3 listed)
- Patients unable to fill out questionnaires (e.g., severe mental illness or cognitive dysfunction);
- Patients suffering from concomitant malignancies in other sites and in active treatment;
- Patients with a history of cancer not currently on active treatment may be enrolled.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairesAnamnestic and socio-demographic information will be collected through a generic self-designed questionnaire including the following data: age, sex, residence (within or outside the Veneto region), marital status (married, divorced, cohabiting, single, widowed), employment status (employed, unemployed, retired), presence of dependents (yes/no), level of education (defined as primary, middle or high school, university degree), concomitant pathologies. Additional data on the oncological history are also reported: histology and staging of the disease, presence or absence of metastatic disease, additional treatments before or after surgery (e.g. neoadjuvant treatments, adjuvant treatments, radiotherapy). | Other | PROFFIT and EORTC QLQ-C30 questionnaires |
Primary outcome
Primary Objective and end point
Time frame: Through study completion, an average of 1 year
Assess financial toxicity using the PROFFIT questionnaire in patients treated with robotic surgery for urological tumors. The PROFFIT questionnaire comprises the financial toxicity score (composed of the first 7 items) plus 9 other individual items indicating the possible determinants of financial difficulties. These items cover three main areas, such as medical expenses (items 8 to 11), transportation (items 12 and 13), and support for medical/health personnel (items 14 to 16).
2 secondary outcomes
Secondary Objective and end point
Time frame: Through study completion, an average of 1 year
Secondary Objective and end point
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Prostate Cancer and Bladder Cancer, run by Istituto Oncologico Veneto IRCCS 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 16 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective and end point (time frame: Through study completion, an average of 1 year). 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 16 Jul 2026.