Medication Monitoring for Breast Cancer

Overseen By Laura Barnes, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: San Diego State University

Must be taking: Endocrine therapy

Disqualifiers: Non-English speakers, Physical impairments, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

15 Participants Needed

Trial Summary

What is the purpose of 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 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

Willing and able to use the MM system for 6 months

Able to provide informed consent

Have an iPhone or Android phone

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Baseline Assessment

Participants complete baseline surveys and are introduced to the medication monitoring system

1 week

1 visit (virtual)

Monitoring and Intervention

Participants use the integrated medication monitoring system, including Wisepill and Fitbit, and receive personalized interventions via the Digital Trails app

6 months

Continuous monitoring with periodic virtual check-ins

Follow-up

Participants complete follow-up surveys at 3 and 6 months to assess adherence and intervention impact

6 months

2 visits (virtual)

Treatment Details

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.

Participant Groups

Group I: integrated medication monitoring system Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials

182

Recruited

119,000+

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+