IMPACT Trial: Intervention to iMProve AdherenCe Equitably
Recruiting · NCT05496829 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Multicomponent Adherence InterventionUsual Care
What this trial is 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).
Who can take part
Age range
18 Years to 99 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Columbia University Medical Center - New York, New York, United States