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Adherence Intervention in Patients With Metastatic Breast Cancer
P50 Supplement: Improving Medications Adherence Equitably Among Patients With Metastatic Breast Cancer and Cardiovascular Disease
Who can join
Ages 18 to 99 · All sexes
Full 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
About the study
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.
What is being tested
- Multicomponent Adherence Intervention (behavioral)
Sponsor: Columbia University · Participants: 35 · Started: Apr 12, 2024
Contact the study team
- Research Nurse Navigator · Phone: 212-342-5162
- Claire Sathe, MD · Phone: 212-305-8923
Official record on ClinicalTrials.gov — NCT06121453
Locations in the U.S.
| New York | Columbia University Medical Center, New York |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.