Breast Cancer SurvivorNCT06865755
Collaborative Research: Multiscale Modeling and Intervention for Improving Long-Term Medication
A study testing integrated medication monitoring (MM) system in people with Breast Cancer Survivor and Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by San Diego State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 70 years, women only
- Conditions the study is for
- Breast Cancer Survivor, Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- What is being tested?
- integrated medication monitoring (MM) system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 9Show fewer
- are able to provide informed consent;
- are willing and able to use the MM system for 6 months;
- have an Iphone or Android phone.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Laura Barnes, PhD contact
United States1 site
San Diego State University
San Diego, California, 92120
Gabriel Estrella, 619-594-3120, gestrella@sdsu.edu
About this study
Official title: 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.
Read the 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).
- Being tested
- integrated medication monitoring (MM) system
- Keywords
- Single-Arm Study Design, Medication Event Monitoring System (MEMS), Medication Adherence, Breast Cancer Survivors, Personalized Interventions, endocrine therapy, mobile health
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
integrated medication monitoring (MM) systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: integrated medication monitoring (MM) system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6 months after enrollment into study
Intervention component - Instructions
Number of respondents who reported receiving and/or using instructions for using the app
Measured: 6 months after enrollment into the study
Intervention component - calendar
Number of respondents who reported receiving and/or using the app calendar
Measured: 6 months after enrollment into the study
Intervention component - resources
Number of respondents who reported receiving and/or using resources for breast cancer survivors
Measured: 6 months after enrollment into the study
Intervention component - relaxation audio files
Number of respondents who reported receiving and/or using relaxation audio files
Measured: 6 months after enrollment into the study
Intervention component - social support
Number of respondents who reported receiving and/or using information about social support
Measured: 6 months after enrollment into the study
Intervention component - tamoxifen
Number of respondents who reported receiving and/or using information about tamoxifen
Measured: 6 months after enrollment into the study
Intervention component - aromatase inhibitors
Number of respondents who reported receiving and/or using information about aromatase inhibitors
Measured: 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
Measured: 6 months after enrollment into the study
Intervention component - reminders
Number of respondents who reported receiving and/or using information about setting medication reminders
Measured: 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
Measured: 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
Measured: 6 months after enrollment into the study
Intervention component - pacing
Number of respondents who reported receiving and/or using information about pacing
Measured: 6 months after enrollment into the study
Intervention component - relaxation
Number of respondents who reported receiving and/or using information about relaxation
Measured: 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
Measured: 6 months after enrollment into the study
Intervention component - travel
Number of respondents who reported receiving and/or using information about travel
Measured: 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)
Measured: 6 months after enrollment into the study
Intervention component - most useful
Participants will be asked to describe the most useful intervention components (qualitative response)
Measured: 6 months after enrollment into the study
Intervention component - least useful
Participants will be asked to describe the least useful intervention components (qualitative response)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 6 months after enrollment into the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study startDec 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Virginia, National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865755
- Sponsor's protocol ID
- HS-2024-0145
- Other IDs
- R01CA239246
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2024
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We plan to share the data so it can be anonymized in registries such as Open Science Framework or alongside our publications.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deploying and Evaluating a Technology Based System to Help People Adhere to Long Term Medications
- ClinicalTrials.gov ID
- NCT06865755
- Acronym / sponsor ID
- HS-2024-0145
- Keywords
- Single-Arm Study Design, Medication Event Monitoring System (MEMS), Medication Adherence, Breast Cancer Survivors, Personalized Interventions, endocrine therapy, mobile health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- University of Virginia, National Cancer Institute (NCI)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| integrated medication monitoring system | Experimental | Device: integrated medication monitoring (MM) systemThe 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 may qualify
- Ages
- 21 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| integrated medication monitoring (MM) systemWe 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. | Device | integrated medication monitoring system |
Primary outcome
Wisepill MEMS Sensor data collection
Time frame: From enrollment to the end of study at 6 months
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
Intervention component - Introduction
Time frame: 6 months after enrollment into study
Number of respondents who reported receiving and/or using the app introduction
Intervention component - Instructions
Time frame: 6 months after enrollment into the study
Number of respondents who reported receiving and/or using instructions for using the app
Intervention component - calendar
Time frame: 6 months after enrollment into the study
Number of respondents who reported receiving and/or using the app calendar
Intervention component - resources
Time frame: 6 months after enrollment into the study
Number of respondents who reported receiving and/or using resources for breast cancer survivors
Intervention component - relaxation audio files
Time frame: 6 months after enrollment into the study
Number of respondents who reported receiving and/or using relaxation audio files
Intervention component - social support
Time frame: 6 months after enrollment into the study
Number of respondents who reported receiving and/or using information about social support
Intervention component - tamoxifen
Time frame: 6 months after enrollment into the study
Number of respondents who reported receiving and/or using information about tamoxifen
Intervention component - aromatase inhibitors
Time frame: 6 months after enrollment into the study
Number of respondents who reported receiving and/or using information about aromatase inhibitors
Intervention component - routine
Time frame: 6 months after enrollment into the study
Number of respondents who reported receiving and/or using information about establishing a routine for taking medications
Intervention component - reminders
Time frame: 6 months after enrollment into the study
Number of respondents who reported receiving and/or using information about setting medication reminders
Intervention component - joint pain
Time frame: 6 months after enrollment into the study
Number of respondents who reported receiving and/or using information about managing joint pain
Intervention component - hot flashes
Time frame: 6 months after enrollment into the study
Number of respondents who reported receiving and/or using information about managing hot flashes
Intervention component - pacing
Time frame: 6 months after enrollment into the study
Number of respondents who reported receiving and/or using information about pacing
Intervention component - relaxation
Time frame: 6 months after enrollment into the study
Number of respondents who reported receiving and/or using information about relaxation
Intervention component - needs
Time frame: 6 months after enrollment into the study
Number of respondents who reported receiving and/or using information about getting what they need from their health care providers
Intervention component - travel
Time frame: 6 months after enrollment into the study
Number of respondents who reported receiving and/or using information about travel
Intervention component - thoughts
Time frame: 6 months after enrollment into the study
Participants will be asked to describe what they thought about the intervention overall (qualitative response)
Intervention component - most useful
Time frame: 6 months after enrollment into the study
Participants will be asked to describe the most useful intervention components (qualitative response)
Intervention component - least useful
Time frame: 6 months after enrollment into the study
Participants will be asked to describe the least useful intervention components (qualitative response)
Intervention component - most attractive
Time frame: 6 months after enrollment into the study
Participants will be asked to describe which intervention components were most attractive (qualitative response)
Intervention component - least attractive
Time frame: 6 months after enrollment into the study
Participants will be asked to describe which intervention components were least attractive (qualitative response)
Intervention component - problems
Time frame: 6 months after enrollment into the study
Participants will be asked to describe problems they experienced using the intervention application (qualitative response)
Intervention component - changes
Time frame: 6 months after enrollment into the study
Participants will be asked to describe any changes they would make to the intervention (qualitative response)
Intervention component - additional information
Time frame: 6 months after enrollment into the study
Participants will be asked to describe what additional information the intervention should provide (qualitative response)
Intervention component - future use
Time frame: 6 months after enrollment into the study
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Undecided. We plan to share the data so it can be anonymized in registries such as Open Science Framework or alongside our publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Barnes, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing integrated medication monitoring (MM) system in people with Breast Cancer Survivor and Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristen J Wells, PhD (619-594-1919, kwells@sdsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wisepill MEMS Sensor data collection (time frame: From enrollment to the end of study at 6 months). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.