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NCT06121453NARecruiting

Adherence Intervention in Patients With Metastatic Breast Cancer

Columbia University

Start Date

4/12/2024

Completion Date

12/10/2026

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 Criteria

Age Range: 18 years to 99 years

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

Interventions

BEHAVIORAL

Multicomponent Adherence Intervention

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Conditions

Breast Cancer

Locations

Columbia University Medical Center

New York, New York 10032

United States