NCT06955910

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Istituto Oncologico Veneto IRCCS · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: —

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

Interventions

Type	Name	Description
OTHER	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).

Timeline

• Start date: 2025-06-18
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-05-02
• Last updated: 2025-07-10

Locations

1 site across 1 country: Italy