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

NCT07291414 | Recruiting

• 4 other identifiers: UMCC 2025.050NCI-2025-08754HUM00272763R01HS027846
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (1)

• Self-tracked, structured medication safety events or concerns

  Up to 12 months

Study Arms (1)

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.

Other: Educational Intervention; Other: Electronic Health Record Review; Procedure: Follow-Up; Other: Internet-Based Intervention; Other: Interview; Other: Survey Administration

Interventions

Educational Intervention OTHER

Receive educational materials and resources

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Health services research (self-monitoring platform)

Electronic Health Record Review OTHER

Ancillary studies

Health services research (self-monitoring platform)

Follow-Up PROCEDURE

Receive follow-up contact

Also known as: Active Follow-up, Clinical Signs Follow-up, CLSFUP, Follow Up, follow_up, Followed, Followup

Health services research (self-monitoring platform)

Internet-Based Intervention OTHER

Use self-monitoring platform

Health services research (self-monitoring platform)

Interview OTHER

Ancillary studies

Health services research (self-monitoring platform)

Survey Administration OTHER

Ancillary studies

Health services research (self-monitoring platform)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Lung Neoplasms; Prostatic Neoplasms

Interventions

Early Intervention, Educational; Educational Status; Methods; Chromatin Immunoprecipitation Sequencing; Follow-Up Studies; Interviews as Topic

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Chromatin Immunoprecipitation; Genetic Techniques; High-Throughput Nucleotide Sequencing; Sequence Analysis; Sequence Analysis, DNA; Immunoprecipitation; Immunologic Techniques; Cohort Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Data Collection

Study Officials

• Yun Jiang

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

• Yang Gong

  UTHealth Houston McWilliam School of Biomedical Informatics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun Jiang

CONTACT

734-763-3705; jiangyu@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 18, 2025
• Study Start: January 9, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)