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Recruiting NCT05496829

IMPACT Trial: Intervention to iMProve AdherenCe Equitably

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multicomponent Adherence Intervention, Usual Care.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • Behavioral Multicomponent Adherence Intervention
    The adherence intervention will be comprised of a participant preference approach in which all participants undergo a baseline pharmacist-led medication optimization session and are offered training in how to use the patient portal and freely-available smartphone reminder app.
  • Other Usual Care
    Receipt of usual care from providers

Primary outcome measures

  • Number of Participants Adherent to Endocrine Therapy (ET) and CVD Medication at 24 Weeks [Time frame: 24 Weeks]
Secondary outcome measures (12)
  • Number of Participants Adherent to ET and CVD Medication at 52 Weeks [Time frame: 52 Weeks]
  • Change in blood pressure at 24 weeks [Time frame: Baseline to 24 weeks]
  • Change in blood pressure at 52 weeks [Time frame: Baseline to 52 weeks]
  • Change in low-density lipoprotein (LDL) cholesterol [Time frame: Baseline to 52 weeks]
  • Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at 24 weeks [Time frame: Baseline and 24 weeks]
  • Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at 52 weeks [Time frame: Baseline and 52 weeks]
  • Changes in Treatment Satisfaction Questionnaire for Medication (TSQM) at 24 Weeks [Time frame: Baseline and 24 weeks]
  • Changes in Treatment Satisfaction Questionnaire for Medication (TSQM) at 52 Weeks [Time frame: Baseline and 52 weeks]
  • Changes in Medical Adherence Self-Efficacy Scale (MASES) at 24 Weeks [Time frame: Baseline and 24 weeks]
  • Changes in the Medical Adherence Self-Efficacy Scale (MASES) at 52 Weeks [Time frame: Baseline and 52 weeks]
  • Change in Regimen Complexity [Time frame: Baseline and at 52 weeks]
  • Subject reasons using the DOSE-Nonadherence reasons for nonadherence questionnaire [Time frame: at baseline]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Columbia University Medical Center — New York

Publications

  • Sathe C, DeStephano D, Lee S, West H, Beauchemin M, Accordino M, Liyanage-Don N, Crew KD, Kukafka R, Harden E, Hershman DL, Kronish IM. Rationale and design of the IMProving Adherence to medications for breast Cancer and cardiovascular disease equiTably (IMPACT) randomized clinical trial. Contemp Clin Trials. 2025 Sep;156:108009. doi: 10.1016/j.cct.2025.108009. Epub 2025 Jul 11. PMID 40653311

Identifiers

NCT: NCT05496829 · AAAT8817 · 1P50MD017341

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗