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Completed

NCT Number: NCT06955910

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

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).

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Key information

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

questionnaires

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).

Primary outcomes

  1. 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).

Secondary outcomes

  1. Secondary Objective and end point

    Time frame: Through study completion, an average of 1 year

    Evaluate factors associated to increased financial toxicity. Evaluation of the correlation between subjects' demographic characteristics and Financial Toxicity score (first 7 items)

  2. Secondary Objective and end point

    Time frame: Through study completion, an average of 1 year

    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.

Sponsors and collaborators

Lead sponsor

Istituto Oncologico Veneto IRCCS

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 2, 2025
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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