NCT06121453Recruiting
Adherence Intervention in Patients With Metastatic Breast Cancer
P50 Supplement: Improving Medications Adherence Equitably Among Patients With Metastatic Breast Cancer and Cardiovascular Disease
Source: ClinicalTrials.gov · Last updated 28 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- First submitted
- 26 Oct 2023
- Start date
- 12 Apr 2024
- Primary completion date
- 10 Nov 2026
- Lead sponsor
- Columbia University
- Diseases
- Metastatic breast cancer
- NCT number
- NCT06121453
What you commit to
- Study type: Interventional
- Planned participants: 35
- From 12 Apr 2024 to the primary completion date, 10 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Inability to provide informed consent for any other reason (e.g, severe psychiatric illness, active substance use)
Other
- Non-English or Non-Spanish speaking
- Not cognitively able to complete study requirements
- Unavailable for 28 weeks of follow-up
Who the study is looking for
- 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%).
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.