A new clinical trial aims to evaluate the effectiveness and feasibility of a mobile application designed for remote oncology symptom monitoring. The study, led by the University of Pittsburgh in collaboration with the National Cancer Institute (NCI), targets cancer patients undergoing chemotherapy treatment using the Mobile Symptom Monitoring and Alert App. As of October 2023, the trial is listed as ‘not yet recruiting,’ with expected updates anticipated in 2025.
Study Details and Objectives
The upcoming trial is focused on assessing whether remote monitoring via a mobile application can improve symptom reporting, patient adherence, and overall quality of care for individuals undergoing treatment for solid tumor cancers. It specifically targets patients receiving chemotherapy and seeks to determine both the feasibility and acceptability of this technology within clinical workflows.
The trial is sponsored by two key entities: the University of Pittsburgh and the National Cancer Institute (NCI). Both organizations aim to innovate within patient-centered care by leveraging behavior-focused interventions. As the study is still categorized as ‘not yet recruiting,’ no data collection or patient enrollment has taken place as of this announcement.
How Does the App Work?
The Mobile Symptom Monitoring and Alert App is designed to track patient-reported symptoms via a user-friendly interface. It provides real-time alerts for care teams, enabling faster response times to critical symptom changes that may affect treatment efficacy or patient safety. Key features include:
- Daily symptom tracking tailored to cancer-related side effects.
- Automated alerts sent to healthcare providers for threshold-exceeding symptoms.
- Educational resources offered within the app to support patient understanding.
This tool emphasizes integration within existing oncological care plans, aiming to reduce manual tracking methods while maintaining regulatory compliance with electronic health records.
What Are the Clinical Implications?
Remote monitoring tools like the Mobile Symptom Monitoring and Alert App are transforming oncology care by bridging gaps in communication between patients and health teams. If successful, this trial could demonstrate a significant improvement in symptom management outcomes for cancer patients. The research can also provide insights into expanding digital health interventions across other medical fields.
Additionally, regulatory bodies may scrutinize the trial results to determine broader applicability within healthcare institutions and compliance with standards such as those outlined in MDR Annex XIV. Technologies that prove effective during clinical trials may eventually see wider adoption and regulatory validation.
Frequently Asked Questions
- 1. Who is eligible for this study?
The trial will recruit patients diagnosed with cancer, specifically solid tumor cancers, who are undergoing chemotherapy treatments, though recruitment has not yet started.
- 2. What is the intended use of the app?
The Mobile Symptom Monitoring and Alert App is designed to facilitate timely reporting of symptoms to improve care quality and reduce risks during chemotherapy.
- 3. Is participation limited geographically?
Eligibility criteria and recruitment sites specific to this study have not been disclosed yet.
- 4. Who is conducting the study?
The University of Pittsburgh, in collaboration with the National Cancer Institute (NCI), is leading this research initiative.
Key Takeaways
Remote monitoring technologies, such as the Mobile Symptom Monitoring and Alert App, hold promise for enhancing cancer care by supporting symptom tracking and provider awareness. This upcoming clinical trial marks a significant step in validating the practical application of digital tools within oncology. Stakeholders in medical device development and regulatory affairs should monitor this study closely for advancements that could influence clinical and operational practices.
Disclaimer
This article is intended for informational purposes only. It does not constitute legal advice and should not be interpreted as regulatory guidance.
Learn More
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07218874?term=medical+device