A Self-Monitoring Platform for Tracking Medication Safety and Concerns in Cancer Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Solid Neoplasm; Breast Carcinoma; Lung Carcinoma; Colorectal Carcinoma; Prostate Carcinoma
• Intervention / Treatment: Other: Survey Administration; Other: Interview; Other: Electronic Health Record Review; Other: Educational Intervention; Procedure: Follow-Up; Other: Internet-Based Intervention

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yun Jiang; Phone Number: 734-763-3705; Email: jiangyu@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan Comprehensive Cancer Center
      • Contact: Yun Jiang; Phone Number: 734-763-3705; Email: jiangyu@umich.edu
      • Principal Investigator: Yun Jiang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Health services research (self-monitoring platform); 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.

Other: Survey Administration; Ancillary studies; Other: Interview; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Other: Educational Intervention; Receive educational materials and resources; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Procedure: Follow-Up; Receive follow-up contact; Other Names: Active Follow-up; Clinical Signs Follow-up; CLSFUP; Follow Up; follow_up; Followed; Followup; Other: Internet-Based Intervention; Use self-monitoring platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 6 months
Perceived usefulness	Qualitative data, including brief interview data will be analyzed and summarized through content analysis.	Up to 6 months
Ease of use	Qualitative data, including brief interview data will be analyzed and summarized through content analysis.	Up to 6 months
Attitudes toward use	Qualitative data, including brief interview data will be analyzed and summarized through content analysis.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 12 months

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Yun Jiang, University of Michigan Rogel Cancer Center; Principal Investigator: Yang Gong, UTHealth Houston McWilliam School of Biomedical Informatics

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: December 4, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Intestinal Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Colonic Diseases; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Prostatic Neoplasms; Lung Neoplasms; Colorectal Neoplasms; Breast Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Community Health Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Immunologic Techniques; Genetic Techniques; Epidemiologic Studies; Epidemiologic Study Characteristics; Chromatin Immunoprecipitation; High-Throughput Nucleotide Sequencing; Sequence Analysis; Sequence Analysis, DNA; Immunoprecipitation; Cohort Studies; Methods; Interviews as Topic; Early Intervention, Educational; Educational Status; Chromatin Immunoprecipitation Sequencing; Follow-Up Studies
• Other Study ID Numbers: UMCC 2025.050; NCI-2025-08754 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); HUM00272763 (Other Identifier: University of Michigan); R01HS027846 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No