Clinical trial NCT06955910: Assessing Financial Toxicity Using the PROFFIT Questionnaire in Patients Treated With Mini-invasive Approach for Urological Malignancies.
Official title: Assessing Financial Toxicity Using the PROFFIT Questionnaire in Patients Treated With Mini-invasive Approach for Urological Malignancies. UROFIT Study.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Prostate Cancer
Bladder Cancer
Kidney Cancer
Keywords: financial toxicity
PROFFIT questionnaire
robotic surgery
urological tumors
Prostate Cancer
Bladder Cancer
Kidney Cancer
Lead sponsor: Istituto Oncologico Veneto IRCCS
Sponsor class: OTHER
First posted: 2025-05-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

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).

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.

Primary outcomes:
measure: Primary Objective and end point
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Secondary Objective and end point
timeFrame: Through study completion, an average of 1 year
measure: Secondary Objective and end point
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
state: Italy/Padova
Study officials:
References: