Adherence Intervention in Patients With Metastatic Breast Cancer

Study Overview
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Brief Summary
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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 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.

Official Title
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P50 Supplement: Improving Medications Adherence Equitably Among Patients With Metastatic Breast Cancer and Cardiovascular Disease

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Multicomponent Adherence Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm: Adherence Intervention<br>Multicomponent Adherence Intervention | Behavioral: Multicomponent Adherence Intervention<br>* multi-part intervention to reduce barriers to medication use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants on multicomponent adherence intervention | To determine the preliminary efficacy of a multicomponent adherence intervention that targets digital and pharmaco-equity among patients with metastatic breast cancer with at least some nonadherence to endocrine therapy, CDK4/6 inhibitor, and/or at least one oral cardiovascular disease (CVD) medication (either blood pressure or statin medication), based on its impact on concurrent adherence to endocrine therapy, CDK4/6 inhibitor, and to CVD medication at 28 weeks (or at time of progression of MBC, if prior to 28-week timepoint), assessed by a combination of self-report using the Voils DOSE Nonadherence measure and pharmacy fill data using pharmacy dispensing records available in the Electronic Health Record (EHR). | at 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at 28 weeks | Healthcare related quality of life (HRQOL), measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29. | at 28 weeks | 
| Digital Health Literacy Scale | A measure of the basic skills necessary for using digital health services, as assessed by a 3-item questionnaire (questions from the Health Information National Trend Survey (HINTS). Scores range with a higher score indicating better level of literacy.(Health Information National Trend Survey). | at 28 weeks | 
| Number in using the Voils DOSE Nonadherence measure | Number of and intensity of reasons for nonadherence using the Voils DOSE Nonadherence measure (note: reasons include side-effects and perceived need for medications). | at 28 weeks | 
| Changes in Medical Adherence Self-Efficacy Scale (MASES) at 28 Weeks | Self-efficacy with medication regimen, as measured by the Medical Adherence Self- Efficacy Scale (MASES-R). | at 28 weeks | 
| total number of medications and number of doses per day | Medications and regimen complexity | at 28 weeks |