Adherence Intervention for Metastatic Breast Cancer
Adherence Intervention in Patients With Metastatic Breast Cancer
Recruiting
N/AInterventional Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 99
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
35 (estimated)
Sponsor
Columbia University · Other
Who this trial is looking for
This trial is looking for patients with metastatic breast cancer who have trouble sticking to their medication plan. Participants will receive support to help improve their medication adherence.
Are You a Good Fit for This Trial?
Must be takingEndocrine therapyCDK4/6 inhibitor
You may be able to join if
I am at least 18 years old
I have been diagnosed with metastatic breast cancer
I am taking endocrine therapy
I am taking a CDK4/6 inhibitor
I am taking at least one medication for heart health
I have reported some issues with taking my medications
You may not be able to join if
I cannot speak English or Spanish
I am not able to understand what the study involves
I cannot give my consent for any reason
I will not be available for follow-up for 28 weeks
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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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 patien…
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.
Trial Locations
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Eligibility Criteria
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…
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
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