Breast CarcinomaNCT07291414
A Self-Monitoring Platform for Tracking Medication Safety and Concerns in Cancer Patients
A study testing Educational Intervention, Electronic Health Record Review and Follow-Up in people with Breast Carcinoma and Colorectal Carcinoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
This clinical trial evaluates the usefulness of a self-monitoring platform for tracking medication safety events and concerns in patients with lung, colorectal, breast, and prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Carcinoma, Colorectal Carcinoma, Lung Carcinoma
- What is being tested?
- Educational Intervention, Electronic Health Record Review and Follow-Up
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2026to 1 Jan 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants are adult patients (aged 18 years or older)
- Diagnosed with lung, colorectal, breast, or prostate cancer
- Are currently receiving active cancer treatments
- Are self-managing one or more prescribed cancer medications
- Participants must have access to technology devices (smartphone, tablet, computer) to track their experiences or concerns about medication safety events, or their family members can help them access technology devices to track the events or concerns
- Speaks and reads English or has a support person (family member or friend) who can assist
Who cannot join
- Can't access technology or do not use technology
- Do not have access to the internet
- Do not speak or read English
- Not permitted to participate by their health care providers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Yun Jiang, 734-763-3705, jiangyu@umich.edu
Yun Jiang
About this study
Official title: Patient Engagement in Using the Technology for Self-Tracking Medication Safety Events
This clinical trial evaluates the usefulness of a self-monitoring platform for tracking medication safety events and concerns in patients with lung, colorectal, breast, and prostate cancer. Patients receiving oral anticancer agents often encounter challenges in managing complex treatment regimens, potentially life-threatening toxicities, and drug-drug and drug-food interactions at home. To achieve the goal of medication safety, they need to become "vigilant partners" in medication and toxicity self-monitoring, including timely reporting of medication events to clinicians when their care transitions back home. In this study, patients use an online self-monitoring platform to track their experiences or concerns about taking their medications, including their experiences with symptoms. This platform may be a useful way for patients to track problems they have when taking their medications at home and may help them take better care of their health.
- Conditions
- Breast Carcinoma, Colorectal Carcinoma, Lung Carcinoma, Malignant Solid Neoplasm, Prostate Carcinoma
- Being tested
- Educational Intervention, Electronic Health Record Review, Follow-Up, Internet-Based Intervention, Interview
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Lung Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive educational materials and resources
Electronic Health Record ReviewOther
Ancillary studies
Follow-UpProcedure or surgery
Also called Active Follow-up, Clinical Signs Follow-up, CLSFUP, Follow Up
Receive follow-up contact
Internet-Based InterventionOther
Use self-monitoring platform
InterviewOther
Ancillary studies
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Health services research (self-monitoring platform) | Experimental | Patients use the self-monitoring platform to track medication-related safety events and issues at home for 6 months. Patients may receive relevant educational materials and resources via the platform or by email and/or receive follow-up contact from a nurse practitioner as needed over the 6 months. Patients are encouraged to continue using the platform for an additional 6 months after the study period, as desired. Receives: Other: Educational Intervention; Other: Electronic Health Record Review; Procedure: Follow-Up; Other: Internet-Based Intervention; Other: Interview; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported system usability
Self-reported system usability will be assessed using the 10-item System Usability Scale. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Measured: Up to 6 months
Perceived usefulness
Qualitative data, including brief interview data will be analyzed and summarized through content analysis.
Measured: Up to 6 months
Ease of use
Qualitative data, including brief interview data will be analyzed and summarized through content analysis.
Measured: Up to 6 months
Attitudes toward use
Qualitative data, including brief interview data will be analyzed and summarized through content analysis.
Measured: Up to 6 months
Intention to use and continuous use of the system over time
Qualitative data, including brief interview data will be analyzed and summarized through content analysis.
Measured: Up to 12 months
Self-reported patient engagement
Self-reported patient engagement will be measured by the 9-item Twente Engagement with Ehealth Technologies Scale (TWEETS), including three dimensions, behavioral engagement, cognitive engagement, and affective engagement. Will use the overall TWEETS score to evaluate patient engagement in this study, rather than analyzing each dimension separately. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. Will use repeated measures analysis of variance to assess the changes in mean scores of patient engagement. Univariate associations between baseline personal and clinical factors and patient engagement at each time point will be assessed using correlation analyses (Pearson or Spearman), Chi-square tests, or non-parametric Mann-Whitney U tests, depending on the variable types. Multiple linear regressions will be conducted to assess associations between patient engagement and outcomes.
Measured: Up to 6 months
System usage over time
Will be objectively recorded by the system logs and analyzed using Google Analytics (dashboard only), including parameters like the number of logins, number of tab pages clicked, number of events or concerns self-tracked, and more. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Measured: Up to 12 months
Patient activation levels
Patient activation levels will be measured by the Short Form of Patient Activation Measure. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Measured: Up to 6 months
Medication self-management ability
Medication self-management ability will be measured by the Measure of Medication Self-Management. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Measured: Up to 6 months
Symptom distress
Symptom distress will be measured by the 19-item MD Anderson Symptom Inventory. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Measured: Up to 6 months
Health related quality of life
Health-related quality of life will be measured by the 27-item Functional Assessment of Cancer Therapy - General. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Measured: Up to 6 months
Number of emergency room visits
Will be measured by both self-report and chart review. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Measured: Up to 12 months
Number of hospitalizations
Will be measured by both self-report and chart review. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Measured: Up to 12 months
User experiences with the system
Participants' user experiences with the system, such as perceived facilitators or barrios to system use, along with their suggestions for system improvement, will be collected through a brief individual interview. Qualitative data, including brief interview data will be analyzed and summarized through content analysis.
Measured: Up to 6 months
Secondary outcomes (1)
Self-tracked, structured medication safety events or concerns
To understand the nature and causes of events and concerns, self-tracked, structured medication safety events or concerns tracking data from the system, such as the number and types of events or concerns self-tracked, will be summarized using descriptive statistics. The free-text tracking data from the system will be analyzed and summarized through content analysis or natural language processing techniques, depending on data volume.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start9 Jan 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Yun Jiang, Principal investigator, University of Michigan Rogel Cancer CenterYang Gong, Principal investigator, UTHealth Houston McWilliam School of Biomedical Informatics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291414
- Sponsor's protocol ID
- UMCC 2025.050
- Other IDs
- NCI-2025-08754, HUM00272763, R01HS027846
- Status last verified
- Jan 2026
- First submitted
- 4 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Engagement in Using the Technology for Self-Tracking Medication Safety Events
- ClinicalTrials.gov ID
- NCT07291414
- Acronym / sponsor ID
- UMCC 2025.050
- Conditions
- Breast Carcinoma, Colorectal Carcinoma, Lung Carcinoma, Malignant Solid Neoplasm, Prostate Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 18 Dec 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.
This clinical trial evaluates the usefulness of a self-monitoring platform for tracking medication safety events and concerns in patients with lung, colorectal, breast, and prostate cancer. Patients receiving oral anticancer agents often encounter challenges in managing complex treatment regimens, potentially life-threatening toxicities, and drug-drug and drug-food interactions at home. To achieve the goal of medication safety, they need to become "vigilant partners" in medication and toxicity self-monitoring, including timely reporting of medication events to clinicians when their care transitions back home. In this study, patients use an online self-monitoring platform to track their experiences or concerns about taking their medications, including their experiences with symptoms. This platform may be a useful way for patients to track problems they have when taking their medications at home and may help them take better care of their health.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health services research (self-monitoring platform) | Experimental | Other: Educational Intervention, Other: Electronic Health Record Review, Procedure: Follow-Up, Other: Internet-Based Intervention, Other: Interview, Other: Survey AdministrationPatients use the self-monitoring platform to track medication-related safety events and issues at home for 6 months. Patients may receive relevant educational materials and resources via the platform or by email and/or receive follow-up contact from a nurse practitioner as needed over the 6 months. Patients are encouraged to continue using the platform for an additional 6 months after the study period, as desired. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants are adult patients (aged 18 years or older)
- Diagnosed with lung, colorectal, breast, or prostate cancer
- Are currently receiving active cancer treatments
- Are self-managing one or more prescribed cancer medications
- Participants must have access to technology devices (smartphone, tablet, computer) to track their experiences or concerns about medication safety events, or their family members can help them access technology devices to track the events or concerns
Key exclusion criteria (4 listed)
- Can't access technology or do not use technology
- Do not have access to the internet
- Do not speak or read English
- Not permitted to participate by their health care providers
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 |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive educational materials and resources | Other | Health services research (self-monitoring platform) |
| Electronic Health Record ReviewAncillary studies | Other | Health services research (self-monitoring platform) |
| Follow-UpAlso: Active Follow-up, Clinical Signs Follow-up, CLSFUP, Follow UpReceive follow-up contact | Procedure or surgery | Health services research (self-monitoring platform) |
| Internet-Based InterventionUse self-monitoring platform | Other | Health services research (self-monitoring platform) |
| InterviewAncillary studies | Other | Health services research (self-monitoring platform) |
| Survey AdministrationAncillary studies | Other | Health services research (self-monitoring platform) |
Primary outcome
Self-reported system usability
Time frame: Up to 6 months
Self-reported system usability will be assessed using the 10-item System Usability Scale. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Perceived usefulness
Time frame: Up to 6 months
Qualitative data, including brief interview data will be analyzed and summarized through content analysis.
Ease of use
Time frame: Up to 6 months
Qualitative data, including brief interview data will be analyzed and summarized through content analysis.
Attitudes toward use
Time frame: Up to 6 months
Qualitative data, including brief interview data will be analyzed and summarized through content analysis.
Intention to use and continuous use of the system over time
Time frame: Up to 12 months
Qualitative data, including brief interview data will be analyzed and summarized through content analysis.
Self-reported patient engagement
Time frame: Up to 6 months
Self-reported patient engagement will be measured by the 9-item Twente Engagement with Ehealth Technologies Scale (TWEETS), including three dimensions, behavioral engagement, cognitive engagement, and affective engagement. Will use the overall TWEETS score to evaluate patient engagement in this study, rather than analyzing each dimension separately. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. Will use repeated measures analysis of variance to assess the changes in mean scores of patient engagement. Univariate associations between baseline personal and clinical factors and patient engagement at each time point will be assessed using correlation analyses (Pearson or Spearman), Chi-square tests, or non-parametric Mann-Whitney U tests, depending on the variable types. Multiple linear regressions will be conducted to assess associations between patient engagement and outcomes.
System usage over time
Time frame: Up to 12 months
Will be objectively recorded by the system logs and analyzed using Google Analytics (dashboard only), including parameters like the number of logins, number of tab pages clicked, number of events or concerns self-tracked, and more. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Patient activation levels
Time frame: Up to 6 months
Patient activation levels will be measured by the Short Form of Patient Activation Measure. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Medication self-management ability
Time frame: Up to 6 months
Medication self-management ability will be measured by the Measure of Medication Self-Management. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Symptom distress
Time frame: Up to 6 months
Symptom distress will be measured by the 19-item MD Anderson Symptom Inventory. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Health related quality of life
Time frame: Up to 6 months
Health-related quality of life will be measured by the 27-item Functional Assessment of Cancer Therapy - General. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Number of emergency room visits
Time frame: Up to 12 months
Will be measured by both self-report and chart review. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Number of hospitalizations
Time frame: Up to 12 months
Will be measured by both self-report and chart review. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
User experiences with the system
Time frame: Up to 6 months
Participants' user experiences with the system, such as perceived facilitators or barrios to system use, along with their suggestions for system improvement, will be collected through a brief individual interview. Qualitative data, including brief interview data will be analyzed and summarized through content analysis.
1 secondary outcome
Self-tracked, structured medication safety events or concerns
Time frame: Up to 12 months
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 21 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Yun Jiang principal investigator
University of Michigan Rogel Cancer Center
Yang Gong principal investigator
UTHealth Houston McWilliam School of Biomedical Informatics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention, Electronic Health Record Review and Follow-Up in people with Breast Carcinoma and Colorectal Carcinoma, run by University of Michigan Rogel Cancer Center 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 21 Jan 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 Yun Jiang (734-763-3705, jiangyu@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported system usability (time frame: Up to 6 months). The study lists 14 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 21 Jan 2026.