Recruiting

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).

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ClinicalTrials.gov IDNCT05496829

PhaseNA

Enrollment350

SponsorColumbia University

Age18 Years – 99 Years

SexALL

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Conditions studied

Breast Cancer

About this study

Interventions

Behavioral: 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.
Other: Usual Care — Receipt of usual care from providers

Primary outcomes

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

Eligibility information

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

Study locations

Columbia University Medical Center, New York, New York 10032 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-03.