IMPACT Trial: Intervention to IMProve AdherenCe Equitably

Last updated: February 11, 2025
Sponsor: Columbia University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

Usual Care

Multicomponent Adherence Intervention

Clinical Study ID

NCT05496829
AAAT8817
1P50MD017341
  • Ages 18-99
  • All Genders

Study 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

Inclusion

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 notincluding human epidermal growth factor receptor 2 (HER2)-directed therapy,radiation)

  • Patients must be prescribed at least 1 antihypertensive or statin medication for CVDprevention

  • Self-report of at least some nonadherence ET or CVD medication on DOSE-NonadherenceExtent of Nonadherence questionnaire

Exclusion

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 NewYork Presbyterian Health system's Epic EHR

  • Inability to provide informed consent

Study Design

Total Participants: 350
Treatment Group(s): 2
Primary Treatment: Usual Care
Phase:
Study Start date:
March 02, 2023
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

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