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Completed

NCT Number: NCT05168436

A Study of Preferences of Participants and Oncologists for the Characteristics of the Treatment for Renal Cell Carcinoma (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.

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Key information

Conditions

Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Castellon, 12071, Spain

About this study

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.

Who can participate

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

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

Treatment and study plan

Primary outcomes

  1. Utility: Renal cell carcinoma (RCC) participants' preferences

    Time frame: At Baseline

    Utility (preference score) derived for a treatment alternative choice (scenario)

  2. Utility: Oncologists' preferences

    Time frame: At Baseline

    Utility (preference score) derived for a treatment alternative choice (scenario)

Secondary outcomes

  1. Distribution of socio-demographic characteristics of Renal cell carcinoma (RCC) participants: Age

    Time frame: At Baseline

    Mean age, defined as the difference in time between date of birth and baseline visit

  2. Distribution of clinical characteristics of RCC participants: Time since RCC diagnosis

    Time frame: At Baseline

    Mean time to diagnosis, defined as the differences in time between date of diagnosis and baseline visit

  3. Distribution of socio-demographic characteristics of RCC participants: Place of residence

    Time frame: At Baseline

    Place of residence, defined as Province of residence categories at baseline visit

  4. Distribution of socio-demographic characteristics of RCC participants: Gender

    Time frame: At Baseline

    Gender, defined as Gender categories at baseline visit, defined as female and male

  5. Distribution of socio-demographic characteristics of RCC participants: Economic status (income)

    Time frame: At Baseline

    Economic status, defined as Euros per month

  6. Distribution of socio-demographic characteristics of RCC participants: Education level

    Time frame: At Baseline

    Education level, defined as education level categories at baseline visit, defined as primary education, secondary education, university education, third-level studies (masters, doctorate, etc.)

  7. Distribution of socio-demographic characteristics of RCC participants: Working situation

    Time frame: At Baseline

    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

  8. Distribution of socio-demographic characteristics of RCC participants: Transport to the hospital: means, duration and cost

    Time frame: At Baseline

  9. Distribution of socio-demographic characteristics of RCC participants: Other costs derived from the visit to the hospital (parking, meals...)

    Time frame: At Baseline

  10. Distribution of clinical characteristics of RCC participants: American Joint Committee on Cancer (AJCC) Staging

    Time frame: At Baseline

    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

  11. Distribution of clinical characteristics of RCC participants: Charlson index

    Time frame: At Baseline

    Charlson index, defined as Mean score according to Charlson comorbidity index

  12. Distribution of clinical characteristics of RCC participants: Karnofsky Performance Scale Index

    Time frame: At Baseline

    Karnofsky Performance Scale Index categories at baseline visit, defined as (0-100%); Lower score representing worst functional impairment

  13. Distribution of clinical characteristics of RCC participants: Current drug treatment (if applicable)

    Time frame: At Baseline

    Current drug treatment, defined as drug treatment categories at baseline visit

  14. Distribution of clinical characteristics of RCC participants: Identification of previous pharmacological treatments received by the participant for the treatment of RCC

    Time frame: At Baseline

    Previous drug treatment, defined as drug treatment categories at baseline visit

  15. Distribution of clinical characteristics of RCC participants: Description of previous pharmacological treatments received by the participant for the treatment of RCC

    Time frame: At Baseline

    Previous drug treatment, defined as drug treatment categories at baseline visit

  16. Distribution of socio-demographic characteristics of oncologists: Gender

    Time frame: At Baseline

    Gender, defined as Gender categories at baseline visit, defined as female and male

  17. Distribution of socio-demographic characteristics of oncologists: Age

    Time frame: At Baseline

    Mean age, defined as the difference in time between date of birth and baseline visit

  18. Distribution of socio-demographic characteristics of oncologists: Province where employed

    Time frame: At Baseline

    Province where employed, defined as Province categories at baseline visit

  19. Distribution of socio-demographic characteristics of oncologists: Years of experience in RCC

    Time frame: At Baseline

    Years of experience in RCC, defined as Mean time of experience in RCC at baseline visit

  20. Distribution of socio-demographic characteristics of oncologists: Years of experience in oncology

    Time frame: At Baseline

    Years of experience in oncology, defined as Mean time of experience in oncology at baseline visit

  21. Distribution of socio-demographic characteristics of oncologists: Number of participants with RCC seen per year

    Time frame: At Baseline

    Number of participants with RCC seen per year, defined as Mean time of participants with RCC seen per year

  22. Distribution of socio-demographic characteristics of oncologists: Other types of cancer treated

    Time frame: At Baseline

    Other types of cancer treated, defined as other cancers treated

  23. Distribution of socio-demographic characteristics of oncologists: Level/ classification of hospital where employed

    Time frame: At Baseline

    Hospital level or classification categories at baseline visit, defined as first, second, third, and fourth level

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 23, 2021
Registry last updated
Dec 23, 2021

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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