Adherence support for metastatic breast cancer patients on endocrine and CDK4/6 inhibitors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will test a multicomponent adherence intervention aimed at improving medication-taking for patients with metastatic breast cancer who are on endocrine therapy and CDK4/6 inhibitors and have cardiovascular risk factors. The study also measures acceptability and appropriateness of the intervention using validated implementation outcomes and explores how social determinants of health influence nonadherence through interviews. The trial will focus on digitally inclusive and pharmaco-equity approaches to support adherence and will include a subset of participants for qualitative interviews. Enrollment targets adults with MBC who are prescribed ET and CDK4/6i and at least one antihypertensive or statin, with nonadherence identified through screening or pharmacy data.

Why it matters

Who can join: the full rules

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's running

• Columbia University Medical Center
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Research Nurse Navigator
• Email: cancerclinicaltrials@cumc.columbia.edu
• Phone: 212-342-5162

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.