IMPACT Trial: Intervention to IMProve AdherenCe Equitably
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Columbia University
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- Number of Participants Adherent to Endocrine Therapy (ET) and CVD Medication at 24 Weeks
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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).
Investigators
Dawn L. Hershman
Assistant Professor of Medicine, Division of Hematology/Oncology
Columbia University
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
Outcomes
Primary Outcomes
Number of Participants Adherent to Endocrine Therapy (ET) and CVD Medication at 24 Weeks
Time Frame: 24 Weeks
Adherence to ET and CVD medication is a composite of both medication refills at 24 weeks (proportion of days covered (PDC) ≥80%) and self-report of taking the medication (as per DOSE-Nonadherence questionnaire; 3-item questionnaire in which participants with perfect adherence on each item will be categorized as adherent). Participants will be categorized as adherent if they have medication available by pharmacy fills and report being adherent to taking their pills day-today via self report.
Secondary Outcomes
- Number of Participants Adherent to ET and CVD Medication at 52 Weeks(52 Weeks)
- Change in blood pressure at 24 weeks(Baseline to 24 weeks)
- Change in blood pressure at 52 weeks(Baseline to 52 weeks)
- Change in low-density lipoprotein (LDL) cholesterol(Baseline to 52 weeks)
- Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at 24 weeks(Baseline and 24 weeks)
- Changes in Medical Adherence Self-Efficacy Scale (MASES) at 24 Weeks(Baseline and 24 weeks)
- Changes in the Medical Adherence Self-Efficacy Scale (MASES) at 52 Weeks(Baseline and 52 weeks)
- Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at 52 weeks(Baseline and 52 weeks)
- Changes in Treatment Satisfaction Questionnaire for Medication (TSQM) at 24 Weeks(Baseline and 24 weeks)
- Changes in Treatment Satisfaction Questionnaire for Medication (TSQM) at 52 Weeks(Baseline and 52 weeks)
- Change in Regimen Complexity(Baseline and at 52 weeks)
- Subject reasons using the DOSE-Nonadherence reasons for nonadherence questionnaire(at baseline)
- Reasons for Medication Non-adherence using the DOSE-Nonadherence Reasons for Nonadherence Questionnaire at 24 Weeks(24 weeks)
- Reasons for Medication Non-adherence using the DOSE-Nonadherence Reasons for Nonadherence Questionnaire at 52 Weeks(52 weeks)
- Impact of events using the Impact of Events Scale (IES)(Baseline)