Adherence Intervention in Patients With Metastatic Breast Cancer
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorColumbia University
About this trial
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 criteria
Qualifiers
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%).
Disqualifiers
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
Trial design
Treatments tested in this trial
- Multicomponent Adherence Intervention
Treatment groups
35 Participants
are divided into 1 treatment groupSponsors and collaborators
Columbia University
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov