Status:
SUSPENDED
Adherence Intervention in Patients With Metastatic Breast Cancer
Lead Sponsor:
Columbia University
Collaborating Sponsors:
National Institute on Minority Health and Health Disparities (NIMHD)
Conditions:
Breast Cancer
Eligibility:
All Genders
18-99 years
Phase:
NA
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) a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 10 2026
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06121453
Start Date
April 12 2024
End Date
December 10 2026
Last Update
May 22 2025
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032