Digital Health Tools Embedded in a Cancer Genetics Clinic: Observational Study

BACKGROUND Digital Health Tools (DHTs), including wearables and mobile apps, offer promising avenues for personalized care and real-time monitoring, but user engagement and clinical utility—especially in pediatric populations—remain unclear. Li-Fraumeni syndrome (LFS) is a genetic mutation in the TP53 tumor suppressor gene, predisposing individuals to cancer, requiring lifelong surveillance and associated psychological stress. OBJECTIVE We evaluated engagement with DHTs in a cancer genetics clinic for families affected by LFS and explored their utility for patients and clinicians. Our goal was to identify insights that could inform future integration of DHTs in chronic disease populations and contribute to research. METHODS We conducted an observational study (January-December 2022) involving patients with LFS and family members aged 5 years and older. Participants received an Empatica EmbracePlus smartwatch and a suite of self-report surveys assessing psychosocial well-being at varying frequencies (ie, daily, weekly, etc). We used survival analysis to characterize engagement over time across age, TP53 status, and previous cancer history. Generalized additive models were used to explore physiological patterns relative to cancer surveillance events. Semistructured interviews provided qualitative insight into user experiences and preferences. RESULTS We enrolled 9 children and 36 adults. Adults wore their smartwatches more often than children (mean 81%, SD 19% vs mean 56%, SD 26%; t10.1=2.72; P=.02) and were engaged in the study for a longer duration (median retention 153, IQR 119-179; 95% CI 133-177 vs median 77, IQR 36-151; 95% CI 17-171 days; log-rank χ21=4.4; P=.04). Daily wear time was similar between the 2 groups (mean 17.6, SD 3.1 hours vs mean 15.7, SD 2.9 hours; t13.2=1.70; P=.11). There were no differences in survey engagement between adults and children, nor were there differences in engagement across TP53 status or previous cancer history. Children reported greater psychosocial burden, with more depressive symptoms (PHQ-9 [Patient Health Questionnaire-9] score mean 10.0, SD 5.2 vs mean 4.2, SD 4.4; t7.8=2.8; P=.03), worse sleep (PROMIS SRI [patient-reported outcomes measurement information system sleep-related impairment] score mean 22.7, SD 5.9 vs mean 16.5, SD 5.5; t8.1=−2.58; P=.03), and increased frequency of stress (mean 36.3%, SD 19.9% vs mean 14.3%, SD 19.2%; t8.3=−2.7; P=.03) than adults. A suicide alert system was triggered in 5 participants (11%) and prompted timely clinical intervention. Generalized additive model analysis showed individualized yet consistent physiological patterns of stress associated with cancer surveillance. Qualitative feedback from participants identified perceived value in stress awareness, but highlighted challenges with device comfort, functionality, and personalization. CONCLUSIONS DHTs are feasible and can capture clinically meaningful psychological and physiological data in high-risk pediatric and family populations with LFS. They enable timely detection of distress and facilitate targeted interventions. Our findings can inform best practices for patient-centered DHT integration into clinical care, with relevance to pediatric oncology and broader digital health contexts. CLINICALTRIAL