A Study of Preferences of Participants and Oncologists for the Characteristics of the Treatment for Renal Cell Carcinoma (RCC) In Spain And Portugal

Study Overview
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Brief Summary
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The purpose of this observational study is to determine patients' and professionals' preferences for the characteristics (attributes) of the treatment for Renal cell carcinoma (RCC) in Spain and Portugal.

Detailed Description
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This study uses a literature review, qualitative (focus groups) and quantitative methods (discrete-choice experiment, DCE) to determine renal cell carcinoma (RCC) participants and oncologists' preferences. In this clinical trial, the study team will develop a survey consisting of comparisons of hypothetical treatment profiles (scenarios). Scenarios are presented to participants, and each participant chooses the most preferable.

Official Title
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Preferences Of Patients And Oncologists For The Characteristics Of The Treatment For RCC In Spain And Portugal

Conditions
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Renal Cell Carcinoma

Participation Criteria
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Eligibility Criteria
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Oncologists from Spain and Portugal will be identified by the promoter and invited to participate in the study in accordance with the inclusion criteria described below. The oncologist is currently working in a Spanish or Portuguese public hospital. The oncologist has at least 2 years of experience in the management of participants with Renal Cell Carcinoma (RCC). The oncologist has agreed to participate in the study. Participants with a diagnosis of RCC will be identified and recruited by the Principal Investigators of the study, taking into account the inclusion criteria described below. The participant has been diagnosed with RCC for a minimum of 2 months before study inclusion. The participant has received or is currently receiving pharmacological treatment for RCC; The participant has provided the informed consent to participate in the study. The participant must be able to read, understand and complete the survey instrument according to the judgment of the responsible physician. Exclusion Criteria: • Not applicable

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Participants with renal cell carcinoma (RCC) treated with nivolumab | |
| Cohort 2<br>Oncologists with expertise in renal cancer from Spain and Portugal | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Utility: Renal cell carcinoma (RCC) participants' preferences | Utility (preference score) derived for a treatment alternative choice (scenario) | At Baseline | 
| Utility: Oncologists' preferences | Utility (preference score) derived for a treatment alternative choice (scenario) | At Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of socio-demographic characteristics of Renal cell carcinoma (RCC) participants: Age | Mean age, defined as the difference in time between date of birth and baseline visit | At Baseline | 
| Distribution of clinical characteristics of RCC participants: Time since RCC diagnosis | Mean time to diagnosis, defined as the differences in time between date of diagnosis and baseline visit | At Baseline | 
| Distribution of socio-demographic characteristics of RCC participants: Place of residence | Place of residence, defined as Province of residence categories at baseline visit | At Baseline | 
| Distribution of socio-demographic characteristics of RCC participants: Gender | Gender, defined as Gender categories at baseline visit, defined as female and male | At Baseline | 
| Distribution of socio-demographic characteristics of RCC participants: Economic status (income) | Economic status, defined as Euros per month | At Baseline | 
| Distribution of socio-demographic characteristics of RCC participants: Education level | Education level, defined as education level categories at baseline visit, defined as primary education, secondary education, university education, third-level studies (masters, doctorate, etc.) | At Baseline | 
| Distribution of socio-demographic characteristics of RCC participants: Working situation | Working situation, defined as working situation categories at baseline visit defined as full-time employed, part-time employed, self-employed, employed but on temporary sick leave due to RCC, permanent sick leave due to RCC, student, unemployed, retired, housework | At Baseline | 
| Distribution of socio-demographic characteristics of RCC participants: Transport to the hospital: means, duration and cost |  | At Baseline | 
| Distribution of socio-demographic characteristics of RCC participants: Other costs derived from the visit to the hospital (parking, meals...) |  | At Baseline | 
| Distribution of clinical characteristics of RCC participants: American Joint Committee on Cancer (AJCC) Staging | AJCC staging, defined as AJCC disease staging categories at baseline visit defined as Localized disease: Stages I and II; or advanced disease: Stages III and IV | At Baseline | 
| Distribution of clinical characteristics of RCC participants: Charlson index | Charlson index, defined as Mean score according to Charlson comorbidity index | At Baseline | 
| Distribution of clinical characteristics of RCC participants: Karnofsky Performance Scale Index | Karnofsky Performance Scale Index categories at baseline visit, defined as (0-100%); Lower score representing worst functional impairment | At Baseline | 
| Distribution of clinical characteristics of RCC participants: Current drug treatment (if applicable) | Current drug treatment, defined as drug treatment categories at baseline visit | At Baseline | 
| Distribution of clinical characteristics of RCC participants: Identification of previous pharmacological treatments received by the participant for the treatment of RCC | Previous drug treatment, defined as drug treatment categories at baseline visit | At Baseline | 
| Distribution of clinical characteristics of RCC participants: Description of previous pharmacological treatments received by the participant for the treatment of RCC | Previous drug treatment, defined as drug treatment categories at baseline visit | At Baseline | 
| Distribution of socio-demographic characteristics of oncologists: Gender | Gender, defined as Gender categories at baseline visit, defined as female and male | At Baseline | 
| Distribution of socio-demographic characteristics of oncologists: Age | Mean age, defined as the difference in time between date of birth and baseline visit | At Baseline | 
| Distribution of socio-demographic characteristics of oncologists: Province where employed | Province where employed, defined as Province categories at baseline visit | At Baseline | 
| Distribution of socio-demographic characteristics of oncologists: Years of experience in RCC | Years of experience in RCC, defined as Mean time of experience in RCC at baseline visit | At Baseline | 
| Distribution of socio-demographic characteristics of oncologists: Years of experience in oncology | Years of experience in oncology, defined as Mean time of experience in oncology at baseline visit | At Baseline | 
| Distribution of socio-demographic characteristics of oncologists: Number of participants with RCC seen per year | Number of participants with RCC seen per year, defined as Mean time of participants with RCC seen per year | At Baseline | 
| Distribution of socio-demographic characteristics of oncologists: Other types of cancer treated | Other types of cancer treated, defined as other cancers treated | At Baseline | 
| Distribution of socio-demographic characteristics of oncologists: Level/ classification of hospital where employed | Hospital level or classification categories at baseline visit, defined as first, second, third, and fourth level | At Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OPDIVO®, Nivolumab, Preference, RCC