Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
NCT05496829

IMPACT Trial: Intervention to iMProve AdherenCe Equitably

Led by Columbia University · Updated on 2026-05-06

350

Participants Needed

1

Research Sites

265 weeks

Total Duration

On this page

Sponsors

C

Columbia University

Lead Sponsor

N

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

IMPACT Trial: Intervention to iMProve AdherenCe Equitably

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 such as surgery, chemotherapy (excluding HER2-directed therapy), or radiation
  • Prescribed at least one antihypertensive or statin medication for cardiovascular disease prevention
  • Self-report of some nonadherence to endocrine therapy or cardiovascular disease medication on the DOSE-Nonadherence questionnaire
Not Eligible

You will not qualify if you...

  • Evidence of breast cancer recurrence
  • Non-English or non-Spanish speaking
  • Not cognitively able to complete study requirements
  • Do not follow with a primary care provider or cardiologist within the New York Presbyterian Health system's Epic electronic health record
  • Unable to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Columbia University Medical Center

New York, New York, United States, 10032

Actively Recruiting

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Research Team

R

Research Nurse Navigator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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IMPACT Trial: Intervention to iMProve AdherenCe Equitably | DecenTrialz