Breast Cancer Clinical Trial

Adherence Intervention in Patients With Metastatic Breast Cancer

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

35

Study ID:

NCT06121453

Recruitment Status:

Recruiting

Sponsor:

Columbia University

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There is 1 Location for this study

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Columbia University Medical Center
New York New York, 10032, United States More Info
Claire Sathe, MD
Contact
212-305-8923
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

35

Study ID:

NCT06121453

Recruitment Status:

Recruiting

Sponsor:


Columbia University

How clear is this clinincal trial information?

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