IMPACT Trial: Improving Adherence for Breast Cancer and Heart Health

This study, called the IMPACT Trial, is testing a Multicomponent Adherence Intervention for people with early-stage breast cancer. This intervention involves a pharmacist-led medication review, training on using a patient portal, and a smartphone reminder app. The study compares this intervention to usual care. You might be able to join if you are an adult (18-99 years old) with stage I-III breast cancer, are taking endocrine therapy, and also take at least one medication for heart disease prevention (like for high blood pressure or cholesterol). The main goal is to see if the intervention helps people stick to their endocrine therapy and heart disease medications over 24 weeks. The study plans to enroll 350 participants.

Study design
This is an interventional study comparing a Multicomponent Adherence Intervention to usual care. It plans to include 350 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main study goal is measured at 24 weeks, which suggests participants will be followed for at least this long.

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NCT05496829

IMPACT Trial: Intervention to iMProve AdherenCe Equitably

Recruiting
NAAges 18–99InterventionalSupportive care
Columbia University
~350 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:Multicomponent Adherence InterventionUsual Care

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Adherent to Endocrine Therapy (ET) and CVD Medication at 24 Weeks
Measured over 24 Weeks
Breast Cancer
1 sites across 1 states
New York1
  • Dawn Hershman, MD · PRINCIPAL_INVESTIGATOR · Columbia University

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Eligibility criteria

Inclusion

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

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
  • Number of Participants Adherent to Endocrine Therapy (ET) and CVD Medication at 24 Weeks24 Weeks

    Adherence to ET and CVD medication is a composite of both medication refills at 24 weeks (proportion of days covered (PDC) ≥80%) and self-report of taking the medication (as per DOSE-Nonadherence questionnaire; 3-item questionnaire in which participants with perfect adherence on each item will be categorized as adherent). Participants will be categorized as adherent if they have medication available by pharmacy fills and report being adherent to taking their pills day-today via self report.