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).

ClinicalTrials.gov IDNCT05496829

PhaseNA

Enrollment350

SponsorColumbia University

Age18 Years

SexALL

I'm interested View official listing

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: 2026-09-27.