IMPACT Trial: Intervention to iMProve AdherenCe Equitably

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Description

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).

Targeted Conditions

Study Overview

Start Date
March 2, 2023
Completion Date
March 31, 2027
Enrollment
350
Date Posted
August 11, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

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

Eligibility

Minimum Age (years)
18
Maximum Age (years)
99
Eligibility Criteria
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 Contact Info

Study Contact Name
Research Nurse Navigator
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT05496829