Stanford University is spearheading a new clinical trial titled Digital Phenotyping for Psychosocial Screening in Adolescents and Young Adults With Cancer, aiming to evaluate cutting-edge approaches for monitoring mental and emotional health in adolescent cancer patients using mobile technology. Although the trial is listed as not yet recruiting, its significance for psychosocial care and digital health integration in patient populations is undeniable.
As of today, October 23, 2025, regulatory teams, quality professionals, and healthcare providers interested in next-gen medical devices and behavioral interventions should familiarize themselves with this initiative.
In this article:
- What is Digital Phenotyping for Adolescents?
- How Does the MyPHD App Work?
- Implications of This Study
What is Digital Phenotyping for Adolescents?
Digital phenotyping refers to the use of smartphone-based tools to capture real-time behavioral and physiological data. This particular study focuses on adolescents and young adults affected by cancer. Psychosocial challenges in this demographic—including anxiety, depression, and therapy compliance—can be better understood through mobile technology that collects informative environmental and behavioral cues.
The trial, sponsored by Stanford University, aims to expand patient-specific data analysis techniques for improving therapy outcomes. By working with adolescents, researchers hope to customize interventions that optimize both mental and physical recovery processes.
How Does the MyPHD App Work?
The Role of Ecological Momentary Assessment
The study employs a dual-intervention strategy featuring two core components: a device and a behavioral assessment conducted via the My Personal Health Dashboard (MyPHD) smartphone app. One of the key methodologies in this app is Ecological Momentary Assessment (EMA). EMA involves real-time data collection methods where patients self-report their moods, activities, and symptoms throughout the day.
Instead of retrospective assessments, EMA minimizes recall bias and enables clinicians to access highly precise behavioral datasets gathered under naturalistic conditions.
Device Integration for Health Monitoring
The device essentially synchronizes with the smartphone app, collecting additional physiological data that complements EMA findings. Such aggregation enhances the scope of digital phenotyping by combining subjective and objective metrics. In future regulatory reviews, this integration could set new benchmarks for patient-centric care in medical devices.
Implications of This Study
From a regulatory standpoint, studies like this illustrate the expanding territory of digital health. Smartphone apps, though widespread, are increasingly being structured alongside regulated medical devices to meet compliance under frameworks like MDR Annex XIV. Such applications reflect the blending of behavioral sciences with advanced technological designs targeting specific medical purposes.
Adolescents present unique challenges in patient care due to developmental factors. Standardizing assessments for this demographic, paired with digital interventions, may drive future regulatory guidance for clinical evaluation methods. Furthermore, device manufacturers can also observe trends where low-profile, non-invasive devices gain prominence across therapy landscapes.
The outcomes of this study may prompt stakeholders to re-evaluate how dynamic patient populations influence device safety and performance thresholds.
Frequently Asked Questions
- What is the aim of this clinical trial?
The trial seeks to analyze how digital phenotyping tools like the MyPHD app can enhance psychosocial care for adolescents and young adults with cancer. - Who sponsors this study?
Stanford University is the sponsor of the trial. - When does recruitment start?
As of now, the trial is listed as “Not yet recruiting.” Updates will likely be shared on ClinicalTrials.gov. - Is the MyPHD app currently approved for medical use?
The app is being evaluated as part of the trial and is integrated as a behavioral intervention device. - Where can I find additional resources on device regulations?
Visit ClinicalTrials.gov or consult MDR Annex XIV guidelines.
Conclusion
This clinical trial marks a pivotal step in integrating mobile technology with traditional cancer care models for adolescents. By leveraging tools like EMA and physiological devices, stakeholders can expect valuable insights into psychological screening methodologies. Regulatory professionals should keep track of emerging findings to adapt device evaluation criteria accordingly.
Disclaimer
This article is for informational purposes only and does not constitute legal advice. Consult a certified regulatory expert for specific compliance-related inquiries.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07220343?term=medical+device