Collaborative Research: Multiscale Modeling and Intervention for Improving Long-Term Medication
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-70
SponsorSan Diego State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
integrated medication monitoring (MM) system
DeviceWe 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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: integrated medication monitoring systemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
From enrollment to the end of study at 6 months2
Intervention component - Introduction
Number of respondents who reported receiving and/or using the app introduction
Time frame
6 months after enrollment into study3
Intervention component - Instructions
Number of respondents who reported receiving and/or using instructions for using the app
Time frame
6 months after enrollment into the study4
Intervention component - calendar
Number of respondents who reported receiving and/or using the app calendar
Time frame
6 months after enrollment into the studySponsors and contacts
Click on the lead sponsor to view all of their trials.
San Diego State University
Lead sponsor
University of Virginia
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: