Renal Cell CarcinomaNCT05168436
A Study of Preferences of Participants and Oncologists for the Characteristics of the Treatment for Renal Cell Carcinoma (RCC) In Spain And Portugal
An observational study of Renal Cell Carcinoma, run by Bristol-Myers Squibb at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- How many people
- 105 participants
- Where
- 1 siteSpain
- Study dates
- 5 Aug 2019to 13 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Renal Cell Carcinoma
- Keywords
- OPDIVO®, Nivolumab, Preference, RCC
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Utility: Renal cell carcinoma (RCC) participants' preferences
Utility (preference score) derived for a treatment alternative choice (scenario)
Measured: At Baseline
Utility: Oncologists' preferences
Utility (preference score) derived for a treatment alternative choice (scenario)
Measured: At Baseline
Secondary outcomes (23)
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
Measured: 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
Measured: 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
Measured: At Baseline
Distribution of socio-demographic characteristics of RCC participants: Gender
Gender, defined as Gender categories at baseline visit, defined as female and male
Measured: At Baseline
Distribution of socio-demographic characteristics of RCC participants: Economic status (income)
Economic status, defined as Euros per month
Measured: 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.)
Measured: 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
Measured: At Baseline
Distribution of socio-demographic characteristics of RCC participants: Transport to the hospital: means, duration and cost
Measured: At Baseline
Distribution of socio-demographic characteristics of RCC participants: Other costs derived from the visit to the hospital (parking, meals...)
Measured: 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
Measured: At Baseline
Distribution of clinical characteristics of RCC participants: Charlson index
Charlson index, defined as Mean score according to Charlson comorbidity index
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At Baseline
Distribution of socio-demographic characteristics of oncologists: Gender
Gender, defined as Gender categories at baseline visit, defined as female and male
Measured: 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
Measured: At Baseline
Distribution of socio-demographic characteristics of oncologists: Province where employed
Province where employed, defined as Province categories at baseline visit
Measured: 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
Measured: 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
Measured: 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
Measured: At Baseline
Distribution of socio-demographic characteristics of oncologists: Other types of cancer treated
Other types of cancer treated, defined as other cancers treated
Measured: 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
Measured: At Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start5 Aug 2019
- Primary completion13 Jul 2020
- Study completion13 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168436
- Sponsor's protocol ID
- CA209-9W6
- Status last verified
- Dec 2021
- First submitted
- 22 Oct 2021
- Last updated
- 23 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preferences Of Patients And Oncologists For The Characteristics Of The Treatment For RCC In Spain And Portugal
- ClinicalTrials.gov ID
- NCT05168436
- Acronym / sponsor ID
- CA209-9W6
- Conditions
- Renal Cell Carcinoma
- Keywords
- OPDIVO®, Nivolumab, Preference, RCC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 13 Jul 2020 (actual)
- Study completion
- 13 Jul 2020 (actual)
- First posted
- 23 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Participants with renal cell carcinoma (RCC) treated with nivolumab |
| Cohort 2 | – | –Oncologists with expertise in renal cancer from Spain and Portugal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Utility: Renal cell carcinoma (RCC) participants' preferences
Time frame: At Baseline
Utility (preference score) derived for a treatment alternative choice (scenario)
Utility: Oncologists' preferences
Time frame: At Baseline
Utility (preference score) derived for a treatment alternative choice (scenario)
23 secondary outcomes
Distribution of socio-demographic characteristics of Renal cell carcinoma (RCC) participants: Age
Time frame: At Baseline
Distribution of clinical characteristics of RCC participants: Time since RCC diagnosis
Time frame: At Baseline
Distribution of socio-demographic characteristics of RCC participants: Place of residence
Time frame: At Baseline
Distribution of socio-demographic characteristics of RCC participants: Gender
Time frame: At Baseline
Distribution of socio-demographic characteristics of RCC participants: Economic status (income)
Time frame: At Baseline
Distribution of socio-demographic characteristics of RCC participants: Education level
Time frame: At Baseline
Distribution of socio-demographic characteristics of RCC participants: Working situation
Time frame: At Baseline
Distribution of socio-demographic characteristics of RCC participants: Transport to the hospital: means, duration and cost
Time frame: At Baseline
Distribution of socio-demographic characteristics of RCC participants: Other costs derived from the visit to the hospital (parking, meals...)
Time frame: At Baseline
Distribution of clinical characteristics of RCC participants: American Joint Committee on Cancer (AJCC) Staging
Time frame: At Baseline
Distribution of clinical characteristics of RCC participants: Charlson index
Time frame: At Baseline
Distribution of clinical characteristics of RCC participants: Karnofsky Performance Scale Index
Time frame: At Baseline
Distribution of clinical characteristics of RCC participants: Current drug treatment (if applicable)
Time frame: At Baseline
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
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
Distribution of socio-demographic characteristics of oncologists: Gender
Time frame: At Baseline
Distribution of socio-demographic characteristics of oncologists: Age
Time frame: At Baseline
Distribution of socio-demographic characteristics of oncologists: Province where employed
Time frame: At Baseline
Distribution of socio-demographic characteristics of oncologists: Years of experience in RCC
Time frame: At Baseline
Distribution of socio-demographic characteristics of oncologists: Years of experience in oncology
Time frame: At Baseline
Distribution of socio-demographic characteristics of oncologists: Number of participants with RCC seen per year
Time frame: At Baseline
Distribution of socio-demographic characteristics of oncologists: Other types of cancer treated
Time frame: At Baseline
Distribution of socio-demographic characteristics of oncologists: Level/ classification of hospital where employed
Time frame: At Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma, run by Bristol-Myers Squibb at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utility: Renal cell carcinoma (RCC) participants' preferences (time frame: At Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2021.