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

NCT ID: NCT07291414

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2028-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Carcinoma Colorectal Carcinoma Lung Carcinoma Malignant Solid Neoplasm Prostate Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Educational Intervention

Intervention Type OTHER

Receive educational materials and resources

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

Follow-Up

Intervention Type PROCEDURE

Receive follow-up contact

Internet-Based Intervention

Intervention Type OTHER

Use self-monitoring platform

Interview

Intervention Type OTHER

Ancillary studies

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Educational Intervention

Receive educational materials and resources

Intervention Type OTHER

Electronic Health Record Review

Ancillary studies

Intervention Type OTHER

Follow-Up

Receive follow-up contact

Intervention Type PROCEDURE

Internet-Based Intervention

Use self-monitoring platform

Intervention Type OTHER

Interview

Ancillary studies

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Active Follow-up Clinical Signs Follow-up CLSFUP Follow Up follow_up Followed Followup

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yun Jiang

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Yang Gong

Role: PRINCIPAL_INVESTIGATOR

UTHealth Houston McWilliam School of Biomedical Informatics

Locations

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University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Central Contacts

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Yun Jiang

Role: CONTACT

Phone: 734-763-3705

Email: [email protected]

Facility Contacts

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Yun Jiang

Role: primary

Other Identifiers

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NCI-2025-08754

Identifier Type: REGISTRY

Identifier Source: secondary_id

HUM00272763

Identifier Type: OTHER

Identifier Source: secondary_id

R01HS027846

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

UMCC 2025.050

Identifier Type: -

Identifier Source: org_study_id