NCT06687330

Evaluating the Role of Step Counts in Predicting Readmission and Mortality

Evaluating the Role of Step Counts in Predicting Readmission and Mortality in Unplanned Hospitalized Cancer Patients: A Prospective Observational Study, STEP-CANCER

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 220 (actual)
• Sponsor: Gazi University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study investigates the relationship between physical activity, heart rate, and sleep quality with recurrent hospitalizations among discharged oncology patients. Following discharge, patients will wear Huawei smartwatches to enable daily tracking of step count, heart rate, and sleep duration through a connected smartphone app. Patients will also complete the FACT Quality of Life Survey and the Pittsburgh Sleep Quality Index during follow-up visits. The smartwatch monitoring will occur during the first 30 days post-discharge, while overall patient follow-up will extend up to 90 days. This study aims to determine if lower levels of home mobility, as indicated by step count and other activity metrics, correlate with an increased risk of hospital readmission within the 30-90 day period.

Detailed description

This observational study aims to investigate the relationship between post-discharge mobility metrics and the likelihood of recurrent hospitalizations among oncology patients. Eligible participants include those who have completed treatment in the oncology ward and have an ECOG performance status of 0-2. Patients admitted only for day treatments or with significant mobility limitations are excluded. Each patient receives a Huawei Watch Fit 2 smartwatch at discharge to record daily step counts, heart rate, and sleep duration, monitored remotely through a smartphone application. In addition to these mobility and physiological metrics, patient-specific factors-such as diagnosis, reason for admission, date of last treatment, cancer stage, and age-are collected, as these may influence follow-up outcomes. Participants complete the FACT Quality of Life Survey and the Pittsburgh Sleep Quality Index at two time points: prior to discharge and again at follow-up, enabling a comparative assessment of quality of life and sleep quality over time. All patients receive general walking recommendations to support their recovery. During the first 30 days post-discharge, activity and physiological data are continuously monitored through the app. The follow-up period extends to 90 days, during which any hospital readmissions are recorded. By analyzing trends in step count, sleep patterns, and heart rate variability, the study aims to determine whether decreased home mobility is associated with a higher risk of readmission, potentially enabling earlier interventions for at-risk individuals. Participant recruitment for this study was completed ahead of schedule due to a higher-than-anticipated rate of eligible patient enrollment. The study is currently in the follow-up phase, and data collection for outcome measures is ongoing. The anticipated primary completion date is June 15, 2025.

Conditions

• Exercise
• Smart Watch
• Quality of Life (QOL)
• Sleep Quality
• Rehospitalization

Interventions

Type	Name	Description
DEVICE	Tracking Mobility and Health Data with a Smartwatch in Discharged Oncology Patients to Predict Rehospitalization: A Prospective Study	The intervention involves daily monitoring of discharged oncology patients using a smartwatch (Huawei Watch Fit 2) to track physical activity (step count), heart rate, and sleep duration. Data is collected remotely via a smartphone app, allowing real-time tracking of health metrics post-discharge. This intervention is distinct in its focus on correlating mobility and physiological data with the risk of rehospitalization within a 30-90 day period. Patients will also receive recommendations to maintain daily walking routines as part of their post-discharge care. Additionally, quality of life and sleep quality assessments are conducted before discharge and at follow-up visits to provide a comprehensive overview of each patient's post-hospital recovery.

Timeline

• Start date: 2024-11-07
• Primary completion: 2025-06-15
• Completion: 2025-08-15
• First posted: 2024-11-13
• Last updated: 2025-08-24

Locations

2 sites across 1 country: Turkey (Türkiye)