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

NCT06865755 | Not Yet Recruiting

• 2 other identifiers: HS-2024-0145R01CA239246
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer Survivor; Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Keywords

Single-Arm Study Design; Medication Event Monitoring System (MEMS); Medication Adherence; Breast Cancer Survivors; Personalized Interventions; endocrine therapy; mobile health

Outcome Measures

Primary Outcomes (26)

• 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

Study Arms (1)

integrated medication monitoring system

EXPERIMENTAL

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

Interventions

integrated medication monitoring (MM) system DEVICE

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.

integrated medication monitoring system

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• San Diego State University: lead
• University of Virginia: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

San Diego State University

San Diego, California, 92120, United States

Location

MeSH Terms

Conditions

Medication Adherence

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Central Study Contacts

Kristen J Wells, PhD

CONTACT

619-594-1919; kwells@sdsu.edu

Laura Barnes, PhD

CONTACT

lb3dp@virginia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: March 10, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (1)