P50 Supplement: Improving Medications Adherence Equitably Among Patients With Metastatic Breast Cancer and Cardiovascular Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Columbia University
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Number of Participants on multicomponent adherence intervention
Study Overview
Brief Summary
To evaluate the preliminary efficacy of a multicomponent adherence intervention focused on enhancing digital equity and pharmaco-equity among nonadherent patients with metastatic breast cancer (MBC) and cardiovascular disease (CVD) risk factors on endocrine therapy (ET), CDK4/6 inhibitor (CDK 4/6i), and CVD medications. To assess the acceptability and appropriateness of this intervention in patients with MBC and CVD risk factors through validated measures of implementation outcomes. To gain a deeper understanding of the impact of social determinants of health (SDOH) on medication nonadherence through semi-structured interviews with a subset of study participants.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women or men age >18 years
- •Diagnosed with stage IV/metastatic breast cancer prescribed endocrine therapy and a CDK4/6i
- •Prescribed at least 1 antihypertensive or statin medication for CVD prevention or treatment
- •Self-report of at least some nonadherence ET/CDK4/6i or CVD medication on nonadherence screener or verbally to a treating clinician, or nonadherent to ET, CDK4/6i, and/or CVD medication on pharmacy fill data in the EHR (proportion of days covered over prior 180 days <80%).
Exclusion Criteria
- •Non-English or Non-Spanish speaking
- •Not cognitively able to complete study requirements
- •Inability to provide informed consent for any other reason (e.g, severe psychiatric illness, active substance use)
- •Unavailable for 28 weeks of follow-up
Arms & Interventions
Single Arm: Adherence Intervention
Multicomponent Adherence Intervention
Intervention: Multicomponent Adherence Intervention (Behavioral)
Outcomes
Primary Outcomes
Number of Participants on multicomponent adherence intervention
Time Frame: at 28 weeks
To determine the preliminary efficacy of a multicomponent adherence intervention that targets digital and pharmaco-equity among patients with metastatic breast cancer with at least some nonadherence to endocrine therapy, CDK4/6 inhibitor, and/or at least one oral cardiovascular disease (CVD) medication (either blood pressure or statin medication), based on its impact on concurrent adherence to endocrine therapy, CDK4/6 inhibitor, and to CVD medication at 28 weeks (or at time of progression of MBC, if prior to 28-week timepoint), assessed by a combination of self-report using the Voils DOSE Nonadherence measure and pharmacy fill data using pharmacy dispensing records available in the Electronic Health Record (EHR).
Secondary Outcomes
- Number in using the Voils DOSE Nonadherence measure(at 28 weeks)
- Changes in Medical Adherence Self-Efficacy Scale (MASES) at 28 Weeks(at 28 weeks)
- Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at 28 weeks(at 28 weeks)
- Digital Health Literacy Scale(at 28 weeks)
- total number of medications and number of doses per day(at 28 weeks)
Investigators
Claire Sathe, MD
Assistant Professor
Columbia University