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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROFFIT and EORTC QLQ-C30 questionnaires |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Through study completion, an average of 1 year |
| Secondary Objective and end point |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Oncologico Veneto | Padova | Italy/Padova | 35128 | Italy |
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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. |
| Through study completion, an average of 1 year |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D007680 | Kidney Neoplasms |
| D000086522 | Financial Stress |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D014571 | Urologic Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D007674 | Kidney Diseases |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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