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

Deploying and Evaluating a Technology Based System to Help People Adhere to Long Term Medications

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer Survivor; Breast Cancer Early Stage Breast Cancer (Stage 1-3)
• Intervention / Treatment: Device: integrated medication monitoring (MM) system

Detailed Description

Purpose/objective:

The investigators have created a new integrated medication monitoring (MM) system for long-term monitoring of medication adherence consisting of baseline, 3-month, and 6-month surveys, smartphone based ecological momentary assessment, smartphone sensors, a medication event monitoring system (MEMS; Wisepill) sensor, and a wrist-worn wearable sensor (Fitbit) that will be used to collect data to understand and model medication-taking behaviors. The objective of the project is to deploy this system to predict nonadherence to endocrine therapy for breast cancer survivors and implement intervention strategies to improve medication adherence. These interventions will be evaluated for preliminary impact on behavior, acceptability, attractiveness, and usefulness.

Overview:

The investigators will conduct a single arm study collecting data in multiple ways and multiple intervals, over six months' time: 1) baseline, 3-month, and 6-month surveys via Qualtrics; 2) smartphone-based ecological momentary assessment (via Digital Trails application) at the following intervals: every 2-3 days, weekly, and monthly; 3) wireless medication event monitoring system devices (MEMS; Wisepill; daily), 4) a wrist-worn wearable sensor (Fitbit; continuous); and 5) smartphone sensors (data collected via Digital Trails application, continuous). Participants will be provided personalized intervention content based on their specific risk via the Digital Trials app. Fifteen breast cancer survivors will be asked to participate in this longitudinal study for six months.

Intervention:

The investigators have created a new integrated medication monitoring (MM) system consisting of baseline, 3-month, and 6-month surveys, smartphone-based ecological momentary assessment via an application installed on a smartphone (Digital Trails based on the UVA Sensus app), a wireless medication event monitoring system device (MEMS; Wisepill), and a wearable sensor (Fitbit), and data collected passively from smartphone sensors using the Digital Trails app. These sources of information will be used to understand predictors of medication taking behaviors and, after two months of monitoring, to deploy appropriate interventions which will be delivered via the Digital Trails app platform. The objective of the project is to deploy this MM system to predict nonadherence to endocrine therapy for breast cancer survivors and implement intervention strategies to improve medication adherence (via Digital Trails). These interventions will be evaluated for preliminary impact on behavior, acceptability, attractiveness, and usefulness.

Participant Eligibility Criteria Fifteen breast cancer survivors will be included in the study if they: 1) are English-speaking and reading; 2) are between ages 21 and 70 years; 3) are diagnosed with stage 0-3 breast cancer in the past 5 years; 4) have completed all surgery, radiation, and chemotherapy, except endocrine therapy; 5) are prescribed endocrine therapy; 6) do not have a physical impairment that would prevent them from using the MM system; 7) are able to provide informed consent; 8) are willing and able to use the MM system for 6 months; and 9) have an Iphone or Android phone.

Participant Recruitment Using convenience sampling, the investigators will recruit 15 breast cancer survivors. The study will be publicized using a number of different ways, including ads on social media. Participants will be directed to complete an online screening survey via Qualtrics or to contact the study staff via email or phone. The investigators will contact interested participants and do a telephone or HIPAA-Zoom screening to assess study inclusion criteria, after obtaining informed consent. The investigators will then provide sensors to participants (via mail) and in a subsequent baseline data collection session (via Zoom), assist participants with completing baseline surveys via Qualtrics, in learning how to use the sensors, and in downloading and using smartphone applications. Participants will be asked to use two sensors: 1) a medication event monitoring system device (MEMS; Wisepill); and 2) a wrist-worn wearable sensor (Fitbit) daily for the next 6 months (see below). Participants will be asked to download the Fitbit and Digital Trails apps to their smartphones. Participants will also be asked to complete ecological momentary assessment (EMA; short surveys) using a smartphone app (Digital Trails) for six months.

Data Collection Digital Trails is an app that combines Sensus, a novel mobile sensing system for Android and iOS capable of collecting data from smartphone and Bluetooth-enabled sensors and administering EMAs, with a smartphone intervention. EMA surveys will be implemented at the following intervals: 1) randomly; 2) every 2- 3 days; 3) every 14 days; and 4) every 28 days. Digital Trails will also collect data from the participants' smartphone if authorized by the participant. These may include, but are not limited to, GPS, accelerometer, gyroscope, and pedometer data. Participants will complete 3 surveys via Qualtrics, at baseline, three month follow-up, and six-month follow-up. These surveys will be administered via Qualtrics. Participants will be asked to use two sensors daily for the entire six month period: 1) a Fitbit wrist sensor; and 2) a Wisepill MEMS cap. The investigators will use the Fitbit Sense smartwatch to collect data including steps, calories burned, total distance traveled, sleep, flights of stairs climbed, active minutes, exercise, and average heart rate. Participants will be asked to download the Fitbit app onto their personal smartphone. Participants' Fitabase data will be monitored by the study team using the Fitabase dashboard.

Primary Outcomes: Adherence to medication, receipt of intervention components, perception of intervention (thoughts, most useful components, lease useful components, most attractive components, least attractive components, problems with the intervention, suggested changes to intervention, additional information that should be provided by intervention, willingness to use intervention/system in future).

Planned analyses:

Evaluation of immediate response to delivery of each intervention module will consist of examining MM data that measure: 1) detection of a risk for missed medication; 2) delivery of the specific intervention module suggested by our modeling; and 3) whether the participant subsequently took the medicine as prescribed after the intervention module was deployed (within a 24 hour interval from the last dose plus or minus 6 hours). The investigators will also summarize data regarding participants' use of each type of module offered and their assessment of the acceptability, attractiveness, and usefulness of intervention modules used. Data collected from close-ended questions (i.e., use of an intervention module) will be summarized using descriptive data (i.e., counts and frequencies). Qualitative data collected from open-ended questions will be summarized using content analysis by having two raters code data on the three a priori themes (i.e., acceptability, attractiveness, and usefulness).

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristen J Wells, PhD; Phone Number: 619-594-1919; Email: kwells@sdsu.edu
• Study Contact Backup: Name: Laura Barnes, PhD; Email: lb3dp@virginia.edu

Study Locations

• United States
  • California
    • San Diego, California, United States, 92120
      • San Diego State University
      • Contact: Gabriel Estrella; Phone Number: 619-594-3120; Email: gestrella@sdsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: integrated medication monitoring system; 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.

Device: integrated medication monitoring (MM) system; We have created a new integrated medication monitoring (MM) system consisting of baseline, 3-month, and 6-month surveys, smartphone-based ecological momentary assessment via an application installed on a smartphone (Digital Trails based on the UVA Sensus app), a wireless medication event monitoring system device (MEMS; Wisepill), and a wearable sensor (Fitbit), and data collected passively from smartphone sensors using the Digital Trails app. These sources of information will be used to understand predictors of medication taking behaviors and, after two months of monitoring, to deploy appropriate interventions which will be delivered via the Digital Trails app platform.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wisepill MEMS Sensor data collection	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	From enrollment to the end of study at 6 months
Intervention component - Introduction	Number of respondents who reported receiving and/or using the app introduction	6 months after enrollment into study
Intervention component - Instructions	Number of respondents who reported receiving and/or using instructions for using the app	6 months after enrollment into the study
Intervention component - calendar	Number of respondents who reported receiving and/or using the app calendar	6 months after enrollment into the study
Intervention component - resources	Number of respondents who reported receiving and/or using resources for breast cancer survivors	6 months after enrollment into the study
Intervention component - relaxation audio files	Number of respondents who reported receiving and/or using relaxation audio files	6 months after enrollment into the study
Intervention component - social support	Number of respondents who reported receiving and/or using information about social support	6 months after enrollment into the study
Intervention component - tamoxifen	Number of respondents who reported receiving and/or using information about tamoxifen	6 months after enrollment into the study
Intervention component - aromatase inhibitors	Number of respondents who reported receiving and/or using information about aromatase inhibitors	6 months after enrollment into the study
Intervention component - routine	Number of respondents who reported receiving and/or using information about establishing a routine for taking medications	6 months after enrollment into the study
Intervention component - reminders	Number of respondents who reported receiving and/or using information about setting medication reminders	6 months after enrollment into the study
Intervention component - joint pain	Number of respondents who reported receiving and/or using information about managing joint pain	6 months after enrollment into the study
Intervention component - hot flashes	Number of respondents who reported receiving and/or using information about managing hot flashes	6 months after enrollment into the study
Intervention component - pacing	Number of respondents who reported receiving and/or using information about pacing	6 months after enrollment into the study
Intervention component - relaxation	Number of respondents who reported receiving and/or using information about relaxation	6 months after enrollment into the study
Intervention component - needs	Number of respondents who reported receiving and/or using information about getting what they need from their health care providers	6 months after enrollment into the study
Intervention component - travel	Number of respondents who reported receiving and/or using information about travel	6 months after enrollment into the study
Intervention component - thoughts	Participants will be asked to describe what they thought about the intervention overall (qualitative response)	6 months after enrollment into the study
Intervention component - most useful	Participants will be asked to describe the most useful intervention components (qualitative response)	6 months after enrollment into the study
Intervention component - least useful	Participants will be asked to describe the least useful intervention components (qualitative response)	6 months after enrollment into the study
Intervention component - most attractive	Participants will be asked to describe which intervention components were most attractive (qualitative response)	6 months after enrollment into the study
Intervention component - least attractive	Participants will be asked to describe which intervention components were least attractive (qualitative response)	6 months after enrollment into the study
Intervention component - problems	Participants will be asked to describe problems they experienced using the intervention application (qualitative response)	6 months after enrollment into the study
Intervention component - changes	Participants will be asked to describe any changes they would make to the intervention (qualitative response)	6 months after enrollment into the study
Intervention component - additional information	Participants will be asked to describe what additional information the intervention should provide (qualitative response)	6 months after enrollment into the study
Intervention component - future use	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.	6 months after enrollment into the study

Collaborators and Investigators

• Sponsor: San Diego State University
• Collaborators: National Cancer Institute (NCI); University of Virginia

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: March 3, 2025
• First Posted (Actual): March 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: mobile health; Medication Adherence; endocrine therapy; Breast Cancer Survivors; Single-Arm Study Design; Medication Event Monitoring System (MEMS); Personalized Interventions
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Medication Adherence; Therapeutics; Drug Therapy; Drug Delivery Systems
• Other Study ID Numbers: HS-2024-0145; R01CA239246 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We plan to share the data so it can be anonymized in registries such as Open Science Framework or alongside our publications.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No