Adherence Intervention in Patients With Metastatic Breast Cancer
Recruiting · NCT06121453 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is 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.
Who can take part
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
Where it is running
1 location listed across 1 US state.
- Columbia University Medical Center - New York, New York, United States