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

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

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.

Study Overview

• Status: Completed
• Conditions: Renal Cell Carcinoma

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.

• Study Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

Study Locations

• Spain
  • Castellon de La Plana, Spain, 12071
    • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cohort 1; Participants with renal cell carcinoma (RCC) treated with nivolumab
Cohort 2; Oncologists with expertise in renal cancer from Spain and Portugal

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2019
• Primary Completion (Actual): July 13, 2020
• Study Completion (Actual): July 13, 2020

Study Registration Dates

• First Submitted: October 22, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (Actual): December 23, 2021

Study Record Updates

• Last Update Posted (Actual): December 23, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Nivolumab; RCC; Preference; OPDIVO®
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma
• Other Study ID Numbers: CA209-9W6

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No