Adherence Intervention in Patients With Metastatic Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multicomponent Adherence Intervention.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
P50 Supplement: Improving Medications Adherence Equitably Among Patients With Metastatic Breast Cancer and Cardiovascular Disease
Overview
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.
Interventions
- Behavioral Multicomponent Adherence Intervention
multi-part intervention to reduce barriers to medication use
Primary outcome measures
- Number of Participants on multicomponent adherence intervention [Time frame: at 28 weeks]
Secondary outcome measures (5)
- Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at 28 weeks [Time frame: at 28 weeks]
- Digital Health Literacy Scale [Time frame: at 28 weeks]
- Number in using the Voils DOSE Nonadherence measure [Time frame: at 28 weeks]
- Changes in Medical Adherence Self-Efficacy Scale (MASES) at 28 Weeks [Time frame: at 28 weeks]
- total number of medications and number of doses per day [Time frame: at 28 weeks]
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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Columbia University Medical Center — New York
Identifiers
NCT: NCT06121453 · AAAU9129 · P50MD017341