IMPACT Trial: Intervention to iMProve AdherenCe Equitably

Columbia University

Status: Enrolling

Conditions: Breast Cancer

Treatments: Other: Usual Care; Behavioral: Multicomponent Adherence Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05496829

AAAT8817

1P50MD017341 (U.S. NIH Grant/Contract)

Details and patient eligibility

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).

Enrollment: 350 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

Adherence Intervention

Experimental group

Description:

Multicomponent Adherence Intervention

Treatment:

Behavioral: Multicomponent Adherence Intervention

Usual Care

Other group

Description:

Usual Care from treating providers

Treatment:

Other: Usual Care