Clinical trial NCT05168436: A Study of Preferences of Participants and Oncologists for the Characteristics of the Treatment for Renal Cell Carcinoma (RCC) In Spain And Portugal
Official title: Preferences Of Patients And Oncologists For The Characteristics Of The Treatment For RCC In Spain And Portugal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Keywords: OPDIVO®
Nivolumab
Preference
RCC
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-12-23
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with diagnosis of Renal Cell Carcinoma (RCC) from a total of eight to eleven hospitals (6-8 located in Spain and 2-3 in Portugal) and oncologists with expertise in renal cancer from Spain and Portugal will participate in the study.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Utility: Renal cell carcinoma (RCC) participants' preferences
timeFrame: At Baseline
measure: Utility: Oncologists' preferences
timeFrame: At Baseline
Secondary outcomes:
measure: Distribution of socio-demographic characteristics of Renal cell carcinoma (RCC) participants: Age
timeFrame: At Baseline
measure: Distribution of clinical characteristics of RCC participants: Time since RCC diagnosis
timeFrame: At Baseline
measure: Distribution of socio-demographic characteristics of RCC participants: Place of residence
timeFrame: At Baseline
measure: Distribution of socio-demographic characteristics of RCC participants: Gender
timeFrame: At Baseline
measure: Distribution of socio-demographic characteristics of RCC participants: Economic status (income)
timeFrame: At Baseline
measure: Distribution of socio-demographic characteristics of RCC participants: Education level
timeFrame: At Baseline
measure: Distribution of socio-demographic characteristics of RCC participants: Working situation
timeFrame: At Baseline
measure: Distribution of socio-demographic characteristics of RCC participants: Transport to the hospital: means, duration and cost
timeFrame: At Baseline
measure: Distribution of socio-demographic characteristics of RCC participants: Other costs derived from the visit to the hospital (parking, meals...)
timeFrame: At Baseline
measure: Distribution of clinical characteristics of RCC participants: American Joint Committee on Cancer (AJCC) Staging
timeFrame: At Baseline
measure: Distribution of clinical characteristics of RCC participants: Charlson index
timeFrame: At Baseline
measure: Distribution of clinical characteristics of RCC participants: Karnofsky Performance Scale Index
timeFrame: At Baseline
measure: Distribution of clinical characteristics of RCC participants: Current drug treatment (if applicable)
timeFrame: At Baseline
measure: Distribution of clinical characteristics of RCC participants: Identification of previous pharmacological treatments received by the participant for the treatment of RCC
timeFrame: At Baseline
measure: Distribution of clinical characteristics of RCC participants: Description of previous pharmacological treatments received by the participant for the treatment of RCC
timeFrame: At Baseline
measure: Distribution of socio-demographic characteristics of oncologists: Gender
timeFrame: At Baseline
measure: Distribution of socio-demographic characteristics of oncologists: Age
timeFrame: At Baseline
measure: Distribution of socio-demographic characteristics of oncologists: Province where employed
timeFrame: At Baseline
measure: Distribution of socio-demographic characteristics of oncologists: Years of experience in RCC
timeFrame: At Baseline
measure: Distribution of socio-demographic characteristics of oncologists: Years of experience in oncology
timeFrame: At Baseline
measure: Distribution of socio-demographic characteristics of oncologists: Number of participants with RCC seen per year
timeFrame: At Baseline
measure: Distribution of socio-demographic characteristics of oncologists: Other types of cancer treated
timeFrame: At Baseline
measure: Distribution of socio-demographic characteristics of oncologists: Level/ classification of hospital where employed
timeFrame: At Baseline
Other outcomes:
Locations:
city: Castellon de La Plana
country: Spain
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: