IMPACT Trial: Intervention to iMProve AdherenCe Equitably
NCT ID: NCT05496829
Last Updated: 2025-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
350 participants
INTERVENTIONAL
2023-03-02
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Adherence Intervention
Multicomponent Adherence Intervention
Multicomponent Adherence Intervention
The adherence intervention will be comprised of a participant preference approach in which all participants undergo a baseline pharmacist-led medication optimization session and are offered training in how to use the patient portal and freely-available smartphone reminder app.
Usual Care
Usual Care from treating providers
Usual Care
Receipt of usual care from providers
Interventions
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Multicomponent Adherence Intervention
The adherence intervention will be comprised of a participant preference approach in which all participants undergo a baseline pharmacist-led medication optimization session and are offered training in how to use the patient portal and freely-available smartphone reminder app.
Usual Care
Receipt of usual care from providers
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
99 Years
ALL
No
Sponsors
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National Institute on Minority Health and Health Disparities (NIMHD)
NIH
Columbia University
OTHER
Responsible Party
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Dawn L. Hershman
Assistant Professor of Medicine, Division of Hematology/Oncology
Principal Investigators
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Dawn Hershman, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Columbia University Medical Center
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Sathe C, DeStephano D, Lee S, West H, Beauchemin M, Accordino M, Liyanage-Don N, Crew KD, Kukafka R, Harden E, Hershman DL, Kronish IM. Rationale and design of the IMProving Adherence to medications for breast Cancer and cardiovascular disease equiTably (IMPACT) randomized clinical trial. Contemp Clin Trials. 2025 Sep;156:108009. doi: 10.1016/j.cct.2025.108009. Epub 2025 Jul 11.
Other Identifiers
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AAAT8817
Identifier Type: -
Identifier Source: org_study_id
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