IMPACT Trial: Intervention to iMProve AdherenCe Equitably

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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)

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

Trial contacts and locations

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Central trial contact

Research Nurse Navigator

Data sourced from clinicaltrials.gov

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