NCT07291414 · University of Michigan Rogel Cancer Center
A Self-Monitoring Platform for Tracking Medication Safety and Concerns in Cancer Patients
What this study is about
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 taken by mouth anticancer agents often encounter challenges in managing complex treatment regimens, potentially life-threatening toxicities, and drug-drug and drug-food interactions at home.
View original scientific description
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.
Interventions
OTHER
Educational Intervention
Receive educational materials and resources
OTHER
Electronic Health Record Review
Ancillary studies
PROCEDURE
Follow-Up
Receive follow-up contact
OTHER
Internet-Based Intervention
Use self-monitoring platform
OTHER
Interview
Ancillary studies
OTHER
Survey Administration
Ancillary studies
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- Ann Arbor, Michigan
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 21, 2026 · Source of record for eligibility and locations