This clinical trial studies how well a multi-part intervention works to improve medication adherence in patients with breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and cardiovascular disease (CVD). The multi-part intervention involves a visit with a pharmacist, installing an application (app) called MyConnect, downloading an app that provides reminders called Medisafe, and reducing barriers to medication delivery that may help patients take medications. This study may help researchers improve medication adherence in patients with metastatic breast cancer and cardiovascular disease.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06121453.
Locations matching your search criteria
United States
New York
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterStatus: Active
Contact: Claire Sathe
Phone: 212-305-1945
PRIMARY OBJECTIVE:
I. To determine the impact of a multicomponent adherence intervention that targets digital and pharmaco-equity among patients with metastatic breast cancer at least one oral medication prescribed for breast cancer treatment (BC Medication) and at least one chronic non-oncological medication (CNOM), based on its impact on concurrent adherence to BC Medications and to CNOM at 28 weeks (or at time of progression of metastatic breast cancer [MBC], if prior to 28-week time point), 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 OBJECTIVES:
I. To assess the impact of the intervention at 28 weeks (or at time of progression of MBC, if prior to 28-week time point) on:
Ia. Self-efficacy with medication regimen, as measured by the Medical Adherence Self-Efficacy Scale (MASES-R);
Ib. Number of and intensity of reasons for nonadherence using the Voils DOSE Nonadherence measure (note: reasons include side-effects and perceived need for medications);
Ic. Self-reported digital literacy, based on the Digital Health Literacy Scale and the HINTS (Health Information National Trend Survey);
Id. Healthcare related quality of life (HRQOL), measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29;
Ie. Medications and regimen complexity (total number of medications and number of doses per day).
II. To evaluate the acceptability, appropriateness, and feasibility of the multicomponent adherence intervention at 28 weeks using the Acceptability of Intervention Measure (AIM), the Intervention Appropriateness Measure (IAM) and the Feasibility of Intervention Measure (FIM) as well as the Net Promoter Scale.
III. To gain a deeper understanding of the impact of social determinants of health on medication nonadherence through semi-structured interviews with a subset of study participants.
OUTLINE:
Patients participate in a medication adherence program composed of medication review and reconciliation, meeting with a pharmacist to assess the usual routine for filling and taking medications, discuss reasons for nonadherence, and develop a personalized plan for medication adherence twice over 4 weeks. Patients also download and use the MyConnect and Medisafe smartphone apps that aid in medication review, notify doctors of questions, request refills, and send reminders for when it's time to take medication for 28 weeks.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationNYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Principal InvestigatorClaire Sathe