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

University of Michigan Rogel Cancer Center

Status: Enrolling

Conditions: Colorectal Carcinoma; Prostate Carcinoma; Lung Carcinoma; Malignant Solid Neoplasm; Breast Carcinoma

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

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07291414

UMCC 2025.050

R01HS027846 (U.S. AHRQ Grant/Contract)

NCI-2025-08754 (Registry Identifier)

HUM00272763 (Other Identifier)

Details and patient eligibility

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 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Health services research (self-monitoring platform)

Experimental group

Description:

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.

Treatment:

Other: Electronic Health Record Review

Other: Internet-Based Intervention

Other: Interview

Other: Educational Intervention

Other: Survey Administration

Procedure: Follow-Up