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Centralized Screening Unit (CSU) at Montefiore-Einstein

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv8
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2025 to Feb 24, 2025
    • Site details revised
    v7
  3. Minor Trial status: Recruiting to Not Yet Recruiting
    • Primary and study completion dates: May 2029 to Jun 2029
    • Start date: Jan 2025 to Mar 2025
    • Site details revised
    v6
  4. Notable Start date: Nov 2024 to Jan 2025
    • Primary and study completion dates: Mar 2029 to May 2029
    v5
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 2024 to Nov 2024
    • Primary and study completion dates: Dec 2028 to Mar 2029
    • Site details revised
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Start date: Apr 2024 to Sep 2024v3
  2. Minor Study description expanded, about 6 wordsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study proposes to increase Lung-cancer screening (LCS) in the Bronx, New York. Despite strong evidence that Lung-cancer screening (LCS) can reduce Lung cancer (LCa) deaths, low-dose computed tomography (LDCT) referral rates by clinicians are very low and there is poor adherence with LCS by patients. Both provider and patient barriers may be amenable to systemic improvements in support, coordination and infrastructure for screening. The investigator team hypothesizes that the implementation of a Central Screening Unit (CSU) that shifts routine workflow attributed to LCS (e.g., collection of smoking history, determination of eligibility, shared decision making and arranging follow-up) away from busy practices (usual care) and that offers patients an array of navigation and support services will increase the uptake of LCS guidelines and subsequent low-dose computed tomography (LDCT) screening scans in a low-income, predominately Hispanic and Black catchment area. The proposed study represents a unique opportunity to test this hypothesis in the context of the roll out of a CSU as a significant new component of the Montefiore-Einstein health system. The investigator team will examine whether and how the CSU facilitates LCS uptake and retention of patients. This study is powered to test whether CSU reduces proportion of late-stage lung cancer diagnoses in the Bronx, New York.
Trial Details
NCT Number NCT06284408
Lead Sponsor Albert Einstein College of Medicine
Collaborators: American Cancer Society, Inc.
Conditions
(from sponsor)
Lung Cancer
Related terms Lung Neoplasms
Enrollment 9,460 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov