Adherence Intervention in Patients With Metastatic Breast Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single Arm: Adherence Intervention Multicomponent Adherence Intervention |
Behavioral: Multicomponent Adherence Intervention
multi-part intervention to reduce barriers to medication use
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 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).
- 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).
- total number of medications and number of doses per day [at 28 weeks]
Medications and regimen complexity
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women or men age >18 years
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Diagnosed with stage IV/metastatic breast cancer prescribed endocrine therapy and a CDK4/6i
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Prescribed at least 1 antihypertensive or statin medication for CVD prevention or treatment
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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:
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Non-English or Non-Spanish speaking
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Not cognitively able to complete study requirements
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Inability to provide informed consent for any other reason (e.g, severe psychiatric illness, active substance use)
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Unavailable for 28 weeks of follow-up
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Columbia University Medical Center | New York | New York | United States | 10032 |
Sponsors and Collaborators
- Columbia University
- National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AAAU9129
- P50MD017341