Adherence Intervention in Patients With Metastatic Breast Cancer

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).

Healthcare related quality of life (HRQOL), measured by the Patient-Reported Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) measuring health-related quality of life. Raw scores (range 1-5 for each question) are translated into T-scores for each domain (physical function, depression, pain intensity, etc) so that the values follow a normal distribution with a population mean T-score of 50 and a standard deviation of 10. Higher scores can mean better or worse outcomes depending on the domain reported.

Outcomes Measurement Information System (PROMIS)-29.

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). To score the 3-item digital health care literacy scale, we used a sum score of all the items (range 0-4 for each item, sum score range 0-12) such that higher scores indicated higher digital health care literacy.

Number of and intensity of reasons for nonadherence using the Voils DOSE Nonadherence measure (note: reasons include side-effects and perceived need for medications).

Self-efficacy with medication regimen, as measured by the Medical Adherence Self- Efficacy Scale (MASES-R). The Medication Adherence Self-Efficacy Scale (MASES). Each question from the 12-item measure is score from 1-4, and the total score for this scale is calculated as the average score of all the items, such that the minimal total score is 1 and the maximal total score is 4. Higher scores indicate higher medication adherence self-efficacy.

Medications and regimen complexity