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IMPACT Trial: Intervention to iMProve AdherenCe Equitably

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 99 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a program helps people take their breast cancer hormone therapy and heart health medicines as prescribed. It is for adults with early-stage breast cancer who report some trouble taking these medicines as prescribed. After 24 weeks, researchers will check surveys and pharmacy refill records.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women or men older than 18.
  • Have stage I–III breast cancer and are prescribed endocrine therapy, a hormone treatment.
  • Finished early cancer treatment, such as surgery, chemotherapy, or radiation, within the past 3 years. HER2-targeted treatment does not count toward this timing.
  • Are prescribed at least one blood pressure medicine or statin, a cholesterol-lowering medicine, to prevent heart or blood vessel disease.
  • Report on a study survey that they do not always take their hormone therapy or heart health medicine as prescribed.

Who can't join

  • There is evidence that the breast cancer has come back.
  • Do not speak English or Spanish.
  • Have thinking or memory problems that prevent them from completing study tasks.
  • Do not see a primary care provider or heart doctor whose records are in the New York Presbyterian health system’s Epic electronic health record.
  • Cannot give informed consent, meaning they cannot understand the study and agree to take part.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

NY