Adherence Intervention in Patients With Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Behavioral: Multicomponent Adherence Intervention
- Registration Number
- NCT06121453
- Lead Sponsor
- Columbia University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 35
- 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%).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm: Adherence Intervention Multicomponent Adherence Intervention Multicomponent Adherence Intervention
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
total number of medications and number of doses per day at 28 weeks Medications and regimen complexity
Trial Locations
- Locations (1)
Columbia University Medical Center
🇺🇸New York, New York, United States