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Recruiting NCT07291414

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

No phase Interventional Breast Carcinoma Colorectal Carcinoma Lung Carcinoma Malignant Solid Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Educational Intervention, Electronic Health Record Review, Follow-Up, Internet-Based Intervention.
Who it may be relevant to
Registry conditions: Breast Carcinoma, Colorectal Carcinoma, Lung Carcinoma, Malignant Solid Neoplasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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]
  • Perceived usefulness [Time frame: Up to 6 months]
  • Ease of use [Time frame: Up to 6 months]
  • Attitudes toward use [Time frame: Up to 6 months]
  • Intention to use and continuous use of the system over time [Time frame: Up to 12 months]
  • Self-reported patient engagement [Time frame: Up to 6 months]
  • System usage over time [Time frame: Up to 12 months]
  • Patient activation levels [Time frame: Up to 6 months]
  • Medication self-management ability [Time frame: Up to 6 months]
  • Symptom distress [Time frame: Up to 6 months]
Secondary outcome measures (1)
  • Self-tracked, structured medication safety events or concerns [Time frame: Up to 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • University of Michigan Comprehensive Cancer Center — Ann Arbor

Identifiers

NCT: NCT07291414 · UMCC 2025.050 · NCI-2025-08754 · HUM00272763 · R01HS027846

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗