Adherence Intervention in Patients With Metastatic Breast Cancer

Columbia University

Status

Enrolling

Conditions

Breast Cancer

Treatments

Behavioral: Multicomponent Adherence Intervention

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06121453

P50MD017341 (U.S. NIH Grant/Contract)

AAAU9129

Details and patient eligibility

About

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.

Enrollment

35 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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