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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan Rogel Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • Educational Intervention

    Other intervention

    Receive educational materials and resources

  • Electronic Health Record Review

    Other intervention

    Ancillary studies

  • Follow-Up

    Procedure/Surgery

    Receive follow-up contact

  • Internet-Based Intervention

    Other intervention

    Use self-monitoring platform

  • Interview

    Other intervention

    Ancillary studies

  • Survey Administration

    Other intervention

    Ancillary studies

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Health services research (self-monitoring platform)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 6 months
2

Perceived usefulness

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

Time frame
Up to 6 months
3

Ease of use

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

Time frame
Up to 6 months
4

Attitudes toward use

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

Time frame
Up to 6 months

Secondary outcomes

1

Self-tracked, structured medication safety events or concerns

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.

Time frame
Up to 12 months

Other outcomes

Sponsors and contacts

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University of Michigan Rogel Cancer Center

Lead sponsor

Agency for Healthcare Research and Quality (AHRQ)

Collaborator