Medication Monitoring for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new system to help breast cancer survivors adhere to their medication routines. The study employs a smartphone app, a special pillbox tracker, and a fitness tracker to gather data and send reminders. It targets individuals who have had stage 0-3 breast cancer, completed most treatments, and are currently on hormone therapy. Participants must be English-speaking and possess a smartphone. The aim is to determine if this system, called the Integrated Medication Monitoring System, can improve medication adherence over six months. As an unphased trial, it offers participants the chance to contribute to innovative solutions that could enhance medication adherence for breast cancer survivors.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, since it involves monitoring medication adherence for those on endocrine therapy, you will likely continue taking your prescribed endocrine therapy.
What prior data suggests that this integrated medication monitoring system is safe for breast cancer survivors?
Research has shown that digital health tools, such as the medication monitoring system under testing, are generally safe. Various studies have used these tools to assist patients in managing their health and adhering to treatment plans.
For instance, one study examined digital health tools for breast cancer patients and found them effective in improving health outcomes. Although specific safety details for this system are not available, digital tools like these are typically easy to use and safe. They track medication use and send reminders, which are non-invasive and generally safe.
In this trial, participants will use a smartphone app and wearable devices to monitor medication use. While there are no direct safety concerns, staying informed and reporting any issues to the research team during the trial is important.12345Why are researchers excited about this trial?
The integrated medication monitoring system is unique because it leverages cutting-edge technology to enhance medication adherence among breast cancer survivors. Unlike traditional treatments that primarily focus on the medication itself, this system uses real-time data from EMA (Ecological Momentary Assessment), MEMS (Medication Event Monitoring System), and Fitbit sensors to track patient behavior and identify those at risk of skipping doses. Researchers are excited about this system because it not only provides personalized reminders through the Digital Trails app but also offers a tailored approach to improve health outcomes by ensuring that patients stick to their prescribed treatment regimens.
What evidence suggests that this integrated medication monitoring system is effective for improving medication adherence in breast cancer survivors?
Research has shown that a combined medication tracking system can help breast cancer survivors adhere to their treatment plans. This trial will use an integrated medication monitoring system, including alert-based tracking, to assist participants in managing their symptoms more effectively. One study found that such tracking systems improved symptom management for breast cancer patients. Another study discovered that eHealth tools, such as apps and wearable devices, are generally well-received by breast cancer survivors. These tools can remind patients to take their medication, aiding in treatment adherence. While some studies have not yet shown a major improvement in adherence, the personalized approach in this trial, using reminders and tracking, might lead to better results.56789
Are You a Good Fit for This Trial?
This trial is for English-speaking breast cancer survivors aged 21-70 who are on endocrine therapy. Participants must be willing to use a smartphone-based monitoring system, a medication event monitoring device (Wisepill), and wear a Fitbit for six months.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants complete baseline surveys and are introduced to the medication monitoring system
Monitoring and Intervention
Participants use the integrated medication monitoring system, including Wisepill and Fitbit, and receive personalized interventions via the Digital Trails app
Follow-up
Participants complete follow-up surveys at 3 and 6 months to assess adherence and intervention impact
What Are the Treatments Tested in This Trial?
Interventions
- Integrated Medication Monitoring System
Trial Overview
The study tests if an integrated medication monitoring system can improve long-term adherence to prescribed endocrine therapy in breast cancer survivors. It involves using tech tools like apps and wearable sensors over six months, with personalized content provided after two months.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
San Diego State University
Lead Sponsor
University of Virginia
Collaborator
National Cancer Institute (NCI)
Collaborator
Citations
Using Integrative Therapies to Improve Patient‐Reported ...
This guideline aims to develop a living evidence‐based clinical practice recommendations to guide the use of integrative therapies for the improvement of ...
Remote Monitoring App for Endocrine Therapy Adherence ...
In this randomized clinical trial of 304 women, a remote monitoring app combined with text messages did not improve AET adherence in the first year.
Mapping the Evidence on the Impact of mHealth ...
Mapping the Evidence on the Impact of mHealth Interventions on Patient-Reported Outcomes in Patients With Breast Cancer: A Systematic Review.
Alert-based patient-reported outcome monitoring improves ...
Researchers also observed a 29% reduction in mortality among patients assigned the intervention. “Based on these findings, [patient-reported ...
Analysing breast cancer survivors' acceptance profiles for ...
This study aims to evaluate the current usability of eHealth technologiesin and to identify differences in BC SURVIVORS BC survivors accepting a medication ...
Electronic Patient-Reported Outcomes With Vital Sign ...
Overall, ePRO and vital sign monitoring did not affect survival outcomes between the 2 groups. The median progression-free survival was 11.1 ...
Evidence-based digital health interventions for breast ...
We conducted an umbrella review to summarize the evidence on digital health interventions aimed at improving health-related outcomes for BCS.
Transforming breast cancer management with real-world ...
Real-world data (RWD) provide essential insights into the effectiveness and safety of breast cancer treatments, particularly in diverse patient populations, ...
Usability Testing of a New Digital Integrated Health ...
This pilot study is to evaluate patients' usability experience at 3 months of a new digital and integrated technological ecosystem, PainRELife, for CP in a ...
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