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NCT Number: NCT07291414

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

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.

Recruiting

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Key information

Conditions

Breast Carcinoma Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Carcinoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Intestinal Diseases Intestinal Neoplasms Lung Carcinoma Lung Diseases Lung Neoplasms Male Urogenital Diseases Malignant Solid Neoplasm Neoplasms Neoplasms by Site Prostate Carcinoma Prostatic Diseases Prostatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Yun Jiang

CONTACT

[email protected]

734-763-3705

Yun Jiang

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Intervention

Other

Receive educational materials and resources

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Electronic Health Record Review

Other

Ancillary studies

Follow-Up

Procedure

Receive follow-up contact

Other names: Active Follow-up, Clinical Signs Follow-up, CLSFUP, Follow Up, follow_up, Followed, Followup

Internet-Based Intervention

Other

Use self-monitoring platform

interview

Other

Ancillary studies

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

  2. Perceived usefulness

    Time frame: Up to 6 months

    Qualitative data, including brief interview data will be analyzed and summarized through content analysis.

  3. Ease of use

    Time frame: Up to 6 months

    Qualitative data, including brief interview data will be analyzed and summarized through content analysis.

  4. Attitudes toward use

    Time frame: Up to 6 months

    Qualitative data, including brief interview data will be analyzed and summarized through content analysis.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

Secondary outcomes

  1. Self-tracked, structured medication safety events or concerns

    Time frame: Up to 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yun Jiang

CONTACT

[email protected]

734-763-3705

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

Patient Engagement in Using the Technology for Self-Tracking Medication Safety Events

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 18, 2025
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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