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Adherence Intervention in Patients With Metastatic Breast Cancer

RECRUITINGN/ASponsored by Columbia University
Actively Recruiting
PhaseN/A
SponsorColumbia University
Started2024-04-12
Est. completion2026-11-10
Eligibility
Age18 Years – 99 Years
Healthy vol.Accepted
Locations1 site

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.

Eligibility

Age: 18 Years – 99 YearsHealthy volunteers accepted
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

Conditions2

Breast CancerCancer

Locations1 site

Columbia University Medical Center
Claire Sathe, MD212-305-8923ds1099@cumc.columbia.edu

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