Wearable-Captured Metrics and ePROs Prove Feasible as Digital Ecosystem in Waldenström Macroglobulinemia

Wearable-captured physiological metrics and electronic patient reported outcomes (ePROs) demonstrated feasibility at a high data completeness level in patients with Waldenström macroglobulinemia, according to findings presented during the 2024 ASCO Breakthrough Conference.

Patients with Waldenström macroglobulinemia included in the study (n = 79) completed daily ePROs at a rate of 60% over a 142-day snapshot; wearable activity and sleep metrics had a completion rate of 85%. The mean EQ-5D-5L score for the entire cohort of patients was 0.760 (SD ± 0.181) and the mean Health State score was 74 (SD ± 18).

The highest mean symptom severity scores on a scale of 1 to 5 reported were fatigue (1.9), weakness (1.7), and numbness/tingling (1.5). Notably, all other symptoms examined had a mean score of 1.4 or less, including breathlessness (1.4), difficulty concentrating/confusion (1.4), vision (1.3), rash (1.2), night sweats (1.2), dizziness/lightheadedness (1.2), constipation (1.2), loss of appetite, (1.2), and diarrhea (1.1). The score of 1 represented no problems and 2 described slight problems reported.

“Waldenström macroglobulinemia is a rare hematological malignancy that has seen the emergence of novel targeted therapies,” Shirley D’Sa, MD, FRCP, FRCPath, said during the presentation. “The condition has a range of clinical features that may significantly impact quality of life and functionality for patients. Current measures of quality of life have limited validity in Waldenström macroglobulinemia, as published by our group recently, [highlighting] an urgent need for disease-specific PROs.”

D’Sa is a consultant hematologist and the clinical lead for the University College London Hospitals Centre for Waldenström’s macroglobulinemia and associated disorders. She is also an honorary associate professor at the University College London Cancer Institute and haematological lead in the joint neurohaematology service at the National Hospital for Neurology in Queen Square, London.

The study examined findings collected via an FDA-cleared wearable smartwatch—which captured activity, sleep, and heart rate data—and a mobile app where patients self-reported daily ePROs. ePROs consisted of treatments received, EQ-5D-5L scores, and disease symptoms, including fatigue, weakness, numbness/tingling, breathlessness, difficulty concentrating/confusion, vision, rash, night sweats, dizziness or light-headedness, constipation, loss of appetite, diarrhea, and vomiting. The results were integrated into a digital platform and anonymized extracts were evaluated both as a cohort and by treatment.

The study objective was to enrich the understanding of the patient experience and to identify potential Waldenström macroglobulinemia-specific metrics via wearable-captured physiological metrics and ePROs. Patients enrolled were a mean age of 65 years (SD ± 10) and most were female (53%). The most recent self-reported treatment entry was prior BTK inhibitor use (22%).

Additional findings from a correlation analysis revealed that increasing activity levels significantly correlated with decreasing symptom severity and increasing quality of life scores (P < .05). A correlation was also reported between lower symptom severity and higher total sleep durations. However, increased difficulty concentrating/confusion, dizziness/light-headedness, and usual activity impairment scores were correlated with increased levels of deep sleep.

Subgroup analysis showed that there were no statistically significant differences between age groups; differences were only present in terms of HR zones among sex subgroups. According to data collected by the wearables, patients who received BTK inhibitors experienced higher breathing disturbance intensities compared with the overall cohort, at 36.8 vs 17.6 (P = .008), respectively, where 0 to 29 was considered a low score, 30 to 59 was medium, and 60-plus was high. Nightly wakeup counts were also elevated among patients who received BTK inhibitors vs the overall cohort, at 1.9 vs 1.6 (P = .038), respectively.

“Our primary and preliminary data support the enrichment of knowledge around baseline physiological and quality of life metrics in Waldenström macroglobulinemia,” D’Sa said in conclusion. “We will further be expanding [our research] through a larger cohort [of patients] and greater depth of health event, complications, and therapeutic intervention impact insights.”

Reference

Summers K, Agrippa O, D’Sa S. New approaches to active monitoring: Patient-reported outcomes and wearables utilisation in Waldenstrom macroglobulinemia. J Clin Oncol. 2024;42(suppl 23):168. doi:10.1200/JCO.2024.42.23_suppl.168