Nctid:
NCT06612034
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000011471", "term"=>"Prostatic Neoplasms"}], "ancestors"=>[{"id"=>"D000005834", "term"=>"Genital Neoplasms, Male"}, {"id"=>"D000014565", "term"=>"Urogenital Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000005832", "term"=>"Genital Diseases, Male"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000011469", "term"=>"Prostatic Diseases"}, {"id"=>"D000052801", "term"=>"Male Urogenital Diseases"}], "browseLeaves"=>[{"id"=>"M14335", "name"=>"Prostatic Neoplasms", "asFound"=>"Prostate Cancer", "relevance"=>"HIGH"}, {"id"=>"M8946", "name"=>"Genital Neoplasms, Male", "relevance"=>"LOW"}, {"id"=>"M17315", "name"=>"Urogenital Neoplasms", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "relevance"=>"LOW"}, {"id"=>"M8944", "name"=>"Genital Diseases, Male", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14333", "name"=>"Prostatic Diseases", "relevance"=>"LOW"}, {"id"=>"M27095", "name"=>"Male Urogenital Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"CROSS_SECTIONAL", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>400}, "targetDuration"=>"1 Day", "patientRegistry"=>true}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-11-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-02-15", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-21", "studyFirstSubmitQcDate"=>"2024-09-21", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-01-15", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Characterization of global disparities in prostate cancer diagnosis, treatment, and management practices", "timeFrame"=>"One month", "description"=>"Comparative analyses will be conducted using survey data to reveal disparities between different regions and healthcare settings. The findings will be presented as percentages of respondents, with territorial and institutional differences thoroughly evaluated. Participants will be categorized into three groups based on the World Bank\\'s income classification: low and lower-middle, upper-middle, and high-income countries. Descriptive statistics will be employed to compare demographic characteristics and clinical practices. For categorical data analysis, the Pearson Chi-Square or Fisher\\'s Exact test will be utilized, while ANOVA tests will be applied to independent variables. A p-value of less than 0.05 will be considered statistically significant."}], "secondaryOutcomes"=>[{"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", "description"=>"Identifying the percentage of healthcare professionals across various geographic regions who have access to diagnostic and treatment methods that align with established guidelines, and evaluating the impact of these methods on treatment outcomes. The findings will be presented as percentages of respondents, with territorial and institutional differences thoroughly examined."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["prostate cancer", "Human Development Index", "survey", "access to medicine", "multidisciplinary care"], "conditions"=>["Prostate CA"]}, "descriptionModule"=>{"briefSummary"=>"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.\n\nThe 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.", "detailedDescription"=>"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.\n\nObjectives:\n\n1. 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.\n2. To identify and quantify disparities in access to and availability of standard care, novel treatments, and supportive services for patients with prostate cancer.\n3. To evaluate the adherence levels to both international and national guidelines in prostate cancer treatment across diverse healthcare systems.\n\nMethods:\n\nThe 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.\n\nData Analysis Plan:\n\nStatistical 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.\n\nExpected Impact:\n\nBy 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."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"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", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\nUrologists, Uro-oncologists, Medical oncologists, Radiation oncologists\n\nExclusion Criteria:\n\nNon-clinical healthcare professionals Healthcare professionals not directly involved in the care of prostate cancer patients, Healthcare professionals with missing or incorrect email addresses"}, "identificationModule"=>{"nctId"=>"NCT06612034", "briefTitle"=>"Prostate Cancer Care Disparity Analysis Project (ProGAP)", "organization"=>{"class"=>"OTHER", "fullName"=>"Ankara University"}, "officialTitle"=>"Evaluating the Worldwide Landscape of Prostate Cancer Management", "orgStudyIdInfo"=>{"id"=>"ANKARA-UNIVERSITY-YURUN-01"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Healthcare professionals for prostate cancer", "description"=>"Healthcare professionals actively engaged in prostate cancer treatment, including urologists, uro-oncologists, medical oncologists, and radiation oncologists", "interventionNames"=>["Other: No Intervention: Observational Cohort"]}], "interventions"=>[{"name"=>"No Intervention: Observational Cohort", "type"=>"OTHER", "description"=>"No Intervention: Observational Cohort", "armGroupLabels"=>["Healthcare professionals for prostate cancer"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Yüksel Ürün", "role"=>"CONTACT", "email"=>"yukselurun@gmail.com", "phone"=>"800-555-5555"}, {"name"=>"Satı Coşkun Yazgan", "role"=>"CONTACT", "email"=>"coskunyazgann491@gmail.com", "phone"=>"800-555-5555", "phoneExt"=>"+905304517798"}], "overallOfficials"=>[{"name"=>"Yüksel Ürün", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Ankara University"}, {"name"=>"Deborah Mukherji", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Clemenceau Medical Center Hospital Dubai"}, {"name"=>"Mohammed Shahait", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Al Zahra Hospital Dubai"}, {"name"=>"Luis Castelo Branco", "role"=>"STUDY_DIRECTOR", "affiliation"=>"IOSI Oncologist Institute of Southern Switzerland"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO", "description"=>"The data that support the findings of this study are available from the study director upon reasonable request."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Ankara University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Professor doctor", "investigatorFullName"=>"Yüksel Ürün", "investigatorAffiliation"=>"Ankara University"}}}}
