Resumen

Elegibilidad

Detalles del diseño

Brazos e Intervenciones

Medidas de resultado

Sitios del ensayo

Fuente: NCT06865755

Aún no recluta

Collaborative Research: Multiscale Modeling and Intervention for Improving Long-Term Medication

Intervencionista

Fase no especificada

San Diego State University

Patrocinador: San Diego State University

Última actualización: 27 de abril de 2026

Aviso: La información proviene de registros públicos y puede no reflejar cambios en tiempo real en el centro local.

The goal of this study is to learn about the impact of an integrated medication monitoring system in breast cancer survivors aged 21-70 who are prescribed endocrine therapy. The main question it aims to address is: Does the integrated medication monitoring system improve medication adherence among breast cancer survivors when used over a six-month period?

Fifteen English-speaking breast cancer survivors who meet the inclusion criteria will use a combination of smartphone-based ecological momentary assessments, a medication event monitoring system (Wisepill), and a wearable sensor (Fitbit). After 2 months, participants will be provided personalized content to facilitate medication adherence through an app (Digital Trails) and through WisePill. Participants will complete online surveys at baseline, 3 months, and 6 months to assess their experiences and adherence.

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Categoría de tratamiento

Dispositivo

Erforderliche Mutationen

Ninguna

Ensayo iniciado

28 de julio de 2026

Última actualización por el patrocinador

27 de abril de 2026

Finalización estimada

1 de diciembre de 2026

Contacto del estudio

Nombre:Kristen J Wells, PhD

Correo electrónico:kwells@sdsu.edu

Teléfono:619-594-1919

Nombre:Laura Barnes, PhD

Correo electrónico:lb3dp@virginia.edu

Elegibilidad

Criterios de inclusión

* are English-speaking and reading;

* are between ages 21 and 70 years;

* are diagnosed with stage 0-3 breast cancer in the past 5 years;

* have completed all surgery, radiation, and chemotherapy, except endocrine therapy;

* are prescribed endocrine therapy;

* do not have a physical impairment that would prevent them from using the MM system;

* are able to provide informed consent;

* are willing and able to use the MM system for 6 months;

* have an Iphone or Android phone.

Criterios de exclusión

Ninguno

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Detalles del diseño

AsignaciónN/A

Modelo de intervenciónSingle Group Assignment

EnmascaramientoNone (Open Label)

Número a inscribir15

Brazos e Intervenciones

Brazos

Intervenciones

Tipo: Experimental

Descripción: The single-arm intervention design of this study focuses on delivering a comprehensive integrated medication monitoring system to a cohort of breast cancer survivors. The system will analyze data collected from EMAs, MEMS, and Fitbit sensors to identify participants at risk of nonadherence. Based on this risk assessment, personalized interventions will be delivered through the Digital Trails app, which may include reminders for medication intake, among others.

Intervenciones:

integrated medication monitoring (MM) system

Medidas de resultado

Medidas de resultado primarias

Wisepill MEMS Sensor data collectionFrom enrollment to the end of study at 6 months

Participants will be asked to put their endocrine therapy medication in the Wisepill device and will be asked to open the Wisepill when taking their medicine daily for six months

Intervention component - Introduction6 months after enrollment into study

Number of respondents who reported receiving and/or using the app introduction

Intervention component - Instructions6 months after enrollment into the study

Number of respondents who reported receiving and/or using instructions for using the app

Intervention component - calendar6 months after enrollment into the study

Number of respondents who reported receiving and/or using the app calendar

Intervention component - resources6 months after enrollment into the study

Number of respondents who reported receiving and/or using resources for breast cancer survivors

Intervention component - relaxation audio files6 months after enrollment into the study

Number of respondents who reported receiving and/or using relaxation audio files

Intervention component - social support6 months after enrollment into the study

Number of respondents who reported receiving and/or using information about social support

Intervention component - tamoxifen6 months after enrollment into the study

Number of respondents who reported receiving and/or using information about tamoxifen

Intervention component - aromatase inhibitors6 months after enrollment into the study

Number of respondents who reported receiving and/or using information about aromatase inhibitors

Intervention component - routine6 months after enrollment into the study

Number of respondents who reported receiving and/or using information about establishing a routine for taking medications

Intervention component - reminders6 months after enrollment into the study

Number of respondents who reported receiving and/or using information about setting medication reminders

Intervention component - joint pain6 months after enrollment into the study

Number of respondents who reported receiving and/or using information about managing joint pain

Intervention component - hot flashes6 months after enrollment into the study

Number of respondents who reported receiving and/or using information about managing hot flashes

Intervention component - pacing6 months after enrollment into the study

Number of respondents who reported receiving and/or using information about pacing

Intervention component - relaxation6 months after enrollment into the study

Number of respondents who reported receiving and/or using information about relaxation

Intervention component - needs6 months after enrollment into the study

Number of respondents who reported receiving and/or using information about getting what they need from their health care providers

Intervention component - travel6 months after enrollment into the study

Number of respondents who reported receiving and/or using information about travel

Intervention component - thoughts6 months after enrollment into the study

Participants will be asked to describe what they thought about the intervention overall (qualitative response)

Intervention component - most useful6 months after enrollment into the study

Participants will be asked to describe the most useful intervention components (qualitative response)

Intervention component - least useful6 months after enrollment into the study

Participants will be asked to describe the least useful intervention components (qualitative response)

Intervention component - most attractive6 months after enrollment into the study

Participants will be asked to describe which intervention components were most attractive (qualitative response)

Intervention component - least attractive6 months after enrollment into the study

Participants will be asked to describe which intervention components were least attractive (qualitative response)

Intervention component - problems6 months after enrollment into the study

Participants will be asked to describe problems they experienced using the intervention application (qualitative response)

Intervention component - changes6 months after enrollment into the study

Participants will be asked to describe any changes they would make to the intervention (qualitative response)

Intervention component - additional information6 months after enrollment into the study

Participants will be asked to describe what additional information the intervention should provide (qualitative response)

Intervention component - future use6 months after enrollment into the study

Participants will be asked to describe whether or not they would be willing to use the intervention and monitoring system in the future to remember to take medicines.

Medidas de resultado secundarias

Ninguno

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Sitios del ensayo

San Diego State University

San Diego, California, US

Nombre:Gabriel Estrella

Correo electrónico:gestrella@sdsu.edu

Teléfono:619-594-3120

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