Clinical trial NCT06612034: Prostate Cancer Care Disparity Analysis Project (ProGAP)
Official title: Evaluating the Worldwide Landscape of Prostate Cancer Management
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Prostate CA
Keywords: prostate cancer
Human Development Index
survey
access to medicine
multidisciplinary care
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthcare professionals actively treating prostate cancer patients-such as urologists, uro-oncologists, medical oncologists, and radiation oncologists-who specialize in the diagnosis and treatment of prostate cancer, representing a diverse range of countries categorized as low-income, lower-middle-income, upper-middle-income, and high-income

Brief summary: This international cross-sectional study seeks to evaluate global disparities in prostate cancer management by conducting a thorough comparison of key elements across countries categorized as low-income, lower-middle-income, upper-middle-income, and high-income.

The primary question it addresses is: Are the standards of care for prostate cancer uniformly applied across different geographic regions worldwide? To achieve this, we will recruit physicians specializing in the diagnosis and treatment of prostate cancer from a diverse array of countries within these income classifications. Participants will complete a 17-question online survey.

Detailed description: Prostate cancer stands as one of the most common cancers among men worldwide, with outcomes and care quality significantly varying due to a multitude of factors including geographic location, healthcare infrastructure, socioeconomic status, and clinical practices. The ProGAP project is conceived to delve into these variations, providing a detailed examination of the global landscape of prostate cancer care.

Objectives:

1. To systematically gather and analyze data on current diagnostic methods, treatment modalities, and management practices for prostate cancer from a wide range of countries and healthcare settings.
2. To identify and quantify disparities in access to and availability of standard care, novel treatments, and supportive services for patients with prostate cancer.
3. To evaluate the adherence levels to both international and national guidelines in prostate cancer treatment across diverse healthcare systems.

Methods:

The ProGAP survey will be distributed internationally to healthcare professionals, including urologists, uro-oncologists, medical oncologists, and radiation oncologists, who are actively involved in prostate cancer care. The survey will comprehensively cover demographic details, clinical practice environment, patient demographics and stages managed, guideline adherence, availability and use of diagnostic and treatment options, and multidisciplinary care approaches. A survey and a consent form will be sent to study participants in addition to written information about the study. Completing surveys will take 10-12 minutes. Participants will complete a 17-question online survey. The first part of the form includes questions about demographics and hospital characteristics. The second part contains questions about prostate cancer diagnosis, treatment, and management practices. Participation in this study is entirely voluntary and anonymous. Neither sensitive personal data nor contact information will be collected during the research. This research does not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors, and the investigators declare that they do not have any conflict of interest with the work.

Data Analysis Plan:

Statistical analyses will employ both descriptive and inferential statistics to interpret the survey data. Comparative analyses will be conducted to uncover disparities across different regions and healthcare settings. Advanced statistical methods, such as regression analysis, may be utilized to explore factors associated with variations in care practices and outcomes.

Expected Impact:

By elucidating the disparities in prostate cancer care worldwide, ProGAP aims to stimulate policy changes, guide improvements in clinical practice, and foster international collaborations to enhance the quality of care and outcomes for patients with prostate cancer globally. Insights gained from this project are anticipated to inform stakeholders, including healthcare providers, policymakers, and patient advocacy groups, about critical areas for intervention and improvement.

Eligibility criteria: Inclusion Criteria:

Urologists, Uro-oncologists, Medical oncologists, Radiation oncologists

Exclusion Criteria:

Non-clinical healthcare professionals Healthcare professionals not directly involved in the care of prostate cancer patients, Healthcare professionals with missing or incorrect email addresses

Primary outcomes:
measure: Characterization of global disparities in prostate cancer diagnosis, treatment, and management practices
timeFrame: One month
Secondary outcomes:
measure: Assessment of access to care, encompassing advanced diagnostic tools, treatment modalities, and patient support services; analysis of adherence to guidelines and its effect on treatment outcomes
timeFrame: One month
Other outcomes:
Locations:
Study officials:
affiliation: Ankara University
name: Yüksel Ürün
role: STUDY_DIRECTOR
affiliation: Clemenceau Medical Center Hospital Dubai
name: Deborah Mukherji
role: STUDY_DIRECTOR
affiliation: Al Zahra Hospital Dubai
name: Mohammed Shahait
role: STUDY_DIRECTOR
affiliation: IOSI Oncologist Institute of Southern Switzerland
name: Luis Castelo Branco
role: STUDY_DIRECTOR
References: