Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-27 @ 10:09 PM
Study NCT ID:
NCT03952767
Status:
COMPLETED
Last Update Posted:
2022-10-25
First Post:
2019-05-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The STEPP Study: Sensors To Evaluate Physical Performance
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
The STEPP Study: Sensors To Evaluate Physical Performance
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEPP
Brief 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)
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)
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: