A Study to Better Understand the Diagnosis and Treatment of Polycythaemia Vera
ConditionPolycythemia Vera
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorTakeda
About this trial
PV is a rare, long-term blood cancer that causes the body to make too many blood cells. This can make the blood thicker than normal and the risk of blood clots higher. People with PV often experience symptoms that can affect their daily lives. Understanding how doctors diagnose and treat PV in everyday medical practice in a certain country can help find the differences in knowledge, diagnosis, and treatment of PV across countries.
This study will not review or collect data from actual people with PV. It will collect information on the diagnosis and treatment of PV using a standard set of questions on and examples of fictional (unreal) people with PV. This is called clinical vignette. The study will ask doctors from several countries to complete this survey.
The main aim of this study is to better understand how well doctors know about and diagnose PV and how they treat PV in certain countries.
Other aims are to better understand how PV is managed and treated in everyday medical practice across countries. This includes which treatment people with PV receive once they are diagnosed and how access to medicines and healthcare services and other factors affects a doctor's treatment decisions for PV.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Board-certified or practicing hematology specialists actively managing PV patients.
Currently practicing in a hospital or clinic setting in the Kingdom of Saudi Arabia or Ukraine or Türkiye.
Has managed at least 10 patients with PV during the past 3 to 5 years, or at least 3 to 5 patients with PV during the past 12 months.
Willing and able to provide informed consent and participate in a standardized survey and vignette assessment in a language in which the approved study materials are available, including English, Turkish, or Ukrainian, as applicable to the participating country.
Disqualifiers
Physicians not currently involved in the diagnosis or management of PV patients.
Medical trainees, residents, or fellows not yet board-certified or independently practicing.
Practicing outside of KSA or Ukraine or Türkiye.
Unwilling or unable to provide informed consent or complete the study procedures.
Trial population
Licensed hematologists and hemato-oncologists who are board-certified or independently practicing and actively involved in diagnosing or managing patients with PV will be enrolled.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
No Intervention
Other interventionNo intervention will be administered in this study.
Treatment groups
90 Participants
are divided into 1 treatment groupGroup A: Physician Survey1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participating Physicians Correctly Identifying the Prespecified Diagnostic Criteria and Risk-Classification Factors for PV in Standardized Clinical Vignettes
For each prespecified diagnostic criterion and risk-classification factor, the percentage of participating physicians selecting the protocol-defined correct response will be reported.
Time frame
At completion of the approximately 30-minute survey session (up to 10 months)2
Distribution of Physician Responses Regarding Early Cytoreductive Treatment in PV
The number of participating physicians selecting each response category for the statement 'Early cytoreductive therapy is underutilized in PV management in my region' will be reported using a 5-point Likert agreement scale ranging from 1, 'Strongly disagree,' to 5, 'Strongly agree.' Higher scores indicate greater agreement with the statement. Treatment choices made in the standardized PV clinical vignettes will also be summarized descriptively.
Time frame
At completion of the approximately 30-minute survey session (up to 10 months)3
Concordance of Physician-Reported Diagnostic and Treatment Decisions With Prespecified PV Guideline-Based Criteria
For each applicable survey or vignette decision, the number of participating physicians whose response is concordant with the protocol-defined guideline-based criterion will be reported.
Time frame
At completion of the approximately 30-minute survey session (up to 10 months)4
Distribution of Self-Reported Rate of Adherence to International Guidelines in Diagnostic and Therapeutic Decisions
For each guideline category, the number of participating physicians reporting 'Always,' 'Often,' or 'Rarely' will be summarized. The international guideline most commonly used will also be reported.
Time frame
At completion of the approximately 30-minute survey session (up to 10 months)Secondary outcomes
1
Percentage of Physicians Reporting Use of Diagnostic Procedures and Treatment Modalities Used for PV Management
The percentage of participating physicians reporting use of each prespecified diagnostic procedure and treatment modality, including phlebotomy, aspirin, cytoreductive treatment, and individual treatment agents, will be reported. For each prespecified diagnostic or monitoring tool, the number and percentage of physicians reporting 'Always,' 'Often,' or 'Rarely' will be reported separately for initial diagnosis and ongoing monitoring.
Time frame
At completion of the approximately 30-minute survey session (up to 10 months)2
Percentage of Physicians Reporting Factors Influencing Clinical Decision-Making in PV Management
The percentage of participating physicians selecting each prespecified factor, including physician experience, resource limitations, patient characteristics, treatment preferences, and access-related considerations, as most important in their decision to change PV treatment will be reported.
Time frame
At completion of the approximately 30-minute survey session (up to 10 months)3
Percentage of Physicians Selecting Each Treatment-Management Option in low- and High-Risk PV Clinical Vignettes
Percentage of physicians selecting each prespecified classification and treatment-management option in response to low- and high-risk PV clinical vignettes will be reported. Responses will be descriptively aggregated to summarize commonly reported sequences of treatment without ranking treatment sequences, identifying an optimal sequence, or making causal inferences.
Time frame
At completion of the approximately 30-minute survey session (up to 10 months)4
Percentage of Physicians Reporting Systemic Barriers to Optimal PV Care and Their Perceived Impact
For each prespecified barrier to early cytoreductive therapy, the percentage of physicians rating its impact as high, moderate, or low will be reported. The barriers selected among the top three barriers to optimal PV care will be summarized separately.
Time frame
At completion of the approximately 30-minute survey session (up to 10 months)Locations
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: