Assessing Financial Toxicity Using the PROFFIT Questionnaire in Patients Treated With Mini-invasive Approach for Urological Malignancies.

NCT ID: NCT06955910

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-18
• Study Completion Date: 2026-06-30

Brief 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.

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).

Conditions

Prostate Cancer; Bladder Cancer; Kidney Cancer

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

PROFFIT and EORTC QLQ-C30 questionnaires

questionnaires

Intervention Type: OTHER

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).

Interventions

questionnaires

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Oncologico Veneto IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istituto Oncologico Veneto

Padua, Italy/Padova, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Antonio Amodeo, MD

Role: CONTACT

antonio.amodeo@iov.veneto.it

0423421321

Giuliana Lista, MD

Role: CONTACT

giuliana.lista@iov.veneto.it

0423421321

Facility Contacts

Antonio Amodeo, MD

Role: primary

antonio.amodeo@iov.veneto.it

0423421321

Other Identifiers

IOV-UC-01-2025-UROFIT

Identifier Type: -

Identifier Source: org_study_id