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P50 Supplement: Improving Medications Adherence Equitably Among Patients With Metastatic Breast Cancer and Cardiovascular Disease

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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%).

Locations
United States
New York
Columbia University Medical Center
RECRUITING
New York
Contact Information
Primary
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162
Backup
Claire Sathe, MD
ds1099@cumc.columbia.edu
212-305-8923
Time Frame
Start Date: 2024-04-12
Estimated Completion Date: 2026-12-10
Participants
Target number of participants: 35
Treatments
Experimental: Single Arm: Adherence Intervention
Multicomponent Adherence Intervention
Related Therapeutic Areas
Sponsors
Leads: Columbia University
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)

This content was sourced from clinicaltrials.gov