RECRUITING
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IMPACT Trial: Intervention to iMProve AdherenCe Equitably
To determine the efficacy of a multicomponent adherence intervention among participants with early-stage breast cancer on endocrine therapy and at least one oral cardiovascular disease (CVD) medication on adherence to endocrine therapy and to CVD medication at 24 weeks assessed by self-report using the Domains of Subjective Extent (DOSE)-Nonadherence questionnaire and also by pharmacy fill data assessed in the electronic health record (EHR).
Conditions:
🦠 Breast Cancer
🗓️ Study Start (Actual) 2 March 2023
🗓️ Primary Completion (Estimated) 31 March 2026
✅ Study Completion (Estimated) 31 March 2027
👥 Enrollment (Estimated) 350
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Women or men age \>18 years
    • * Diagnosed with stage I-III breast cancer prescribed endocrine therapy
    • * Within 3-years of the end of early active treatment (e.g., surgery, chemotherapy not including human epidermal growth factor receptor 2 (HER2)-directed therapy, radiation)
    • * Patients must be prescribed at least 1 antihypertensive or statin medication for CVD prevention
    • * Self-report of at least some nonadherence ET or CVD medication on DOSE-Nonadherence Extent of Nonadherence questionnaire

    Exclusion Criteria:

    • * Evidence of breast cancer recurrence
    • * Non-English or Non-Spanish speaking
    • * Not cognitively able to complete study requirements
    • * Do not follow with either a primary care provider or cardiologist within the New York Presbyterian Health system's Epic EHR
    • * Inability to provide informed consent
Ages Eligible for Study: 18 Years to 99 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 17 June 2022
  • First Submitted that Met QC Criteria 9 August 2022
  • First Posted 11 August 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 2 February 2024
  • Last Update Posted 5 February 2024
  • Last Verified February 2024
I'm interested ...!!