NCT03952767

The STEPP Study: Sensors To Evaluate Physical Performance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This study assesses the association between digital functional measures of physical and patient-reported standard onocological assessments, like Karnofsky Performance Score (KPS).

Detailed description

This study assess the association between digital functional measures from physical monitoring devices (devices like a watch tracking steps, a heart rate monitor) and patient-reported standard oncological assessments. The study will also test the feasibility of obtaining the measures in clinic and at home from the monitoring devices in participants with cancer. Participants will be asked to spend 1 hour in clinic performing simple tasks such as walking and standing with 7 digital devices recording movement data. The participants will also be asked to fill out survey data regarding their health. At-home data will be collected for 14 days. During this time participants will wear a watch to collect movement and step data, and a lumbar belt to collect movement data. Primary Objective: 1\. Assess the association of 5 main digital physical functional measures (mean steps per day, mean sedentary activity time, light activity time, moderate activity time, and vigorous activity time (in minutes) per day) recorded at home with patient-reported standard oncological assessment (e.g. KPS)

Conditions

• Oncology

Interventions

Type	Name	Description
OTHER	Digital Physical Measures and Survey Assessments	Data from at home and in clinic visits will assess physical function and survey data will be collected

Timeline

• Start date: 2019-04-24
• Primary completion: 2021-08-30
• Completion: 2022-08-30
• First posted: 2019-05-16
• Last updated: 2022-10-25

Locations

1 site across 1 country: United States