NCT05496829NARecruiting
IMPACT Trial: Intervention to iMProve AdherenCe Equitably
Columbia University
Start Date
3/2/2023
Completion Date
3/31/2028
Summary
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).
Eligibility Criteria
Age Range: 18 years to 99 years
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
Interventions
BEHAVIORAL
Multicomponent Adherence Intervention
OTHER
Usual Care
Conditions
Breast Cancer
Locations
Columbia University Medical Center
New York, New York 10032
United States