Breast Cancer
Conditions
Brief summary
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
BEHAVIORALMulticomponent Adherence Intervention
multi-part intervention to reduce barriers to medication use
Sponsors
Columbia University
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants on multicomponent adherence intervention | at 28 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at 28 weeks | at 28 weeks | 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. |
| Digital Health Literacy Scale | at 28 weeks | 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 in using the Voils DOSE Nonadherence measure | at 28 weeks | Number of and intensity of reasons for nonadherence using the Voils DOSE Nonadherence measure (note: reasons include side-effects and perceived need for medications). |
| Changes in Medical Adherence Self-Efficacy Scale (MASES) at 28 Weeks | at 28 weeks | 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. |
| total number of medications and number of doses per day | at 28 weeks | Medications and regimen complexity |
Countries
United States
Contacts
CONTACTResearch Nurse Navigator
CONTACTClaire Sathe, MD
Outcome results
None listed