The STEPP Study: Sensors To Evaluate Physical Performance

Not Applicable

Completed

• Conditions: Oncology
• Interventions: Other: Digital Physical Measures and Survey Assessments

• Registration Number: NCT03952767
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

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)

Study Timeline

• Study Start: 2019-04-24
• Study First Submitted: 2019-05-13
• Study First Submitted QC: 2019-05-14
• Study First Posted: 2019-05-16
• Primary Completion: 2021-08-30
• Study Completion: 2022-08-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-21
• Last Update Posted: 2022-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

1. All genders aged ≥ 18 years of age
2. Patients being seen at UNCCH for treatment of cancer.
3. English-speakers
4. Able to understand and cooperate with study procedures.
5. Patients with solid tumors or hematological malignancies, and self-reported KPS ≤70 to ≥ 100.

Signed and dated informed consent and HIPPA.

Exclusion Criteria

1. Subjects using investigational/experimental products.
2. Has dementia, altered mental status, or any psychiatric or co-morbid condition prohibiting the understanding or rending of informed consent.
3. Unable or unwilling to complete physical performance assessments including the at-home wearable device for 14 days.
4. Unable to speak English.
5. Subjects who report any other medical condition, recreational substance use, or medication use which would prevent them from completing study tasks or impair the providing of informed consent.
6. Subjects who are allergic to silicone or adhesives. Subjects with cardiac pacemakers, electronic pumps or any other implanted medical devices.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Digital Physical Measures and Survey Assessments	Digital Physical Measures and Survey Assessments	Digital physical measure data will be collected in clinic and at home and survey assessments will be collected

Primary Outcome Measures

Name	Time	Method
Amount of mean steps per day recorded at home	18 months	At-home record of mean steps per day
Amount of Light activity time recorded at home	18 months	At-home record of minutes per day of light activity time per day
Amount of moderate activity time recorded at home	18 months	At-home record of minutes per day of moderate activity time
Amount of vigorous activity time recorded at home	18 months	At-home record of minutes per day of vigorous activity time
Amount of mean sedentary activity time recorded at home	18 months	At-home record of minutes per day of mean sedentary activity time
Self-Reported Karnofsky Performance Score (KPS)	18 months	The validated 1 question Self-reported Karnofsky Performance Score (KPS) score 0 to 100 will be measured. Scores closer to 100 indicate high performance of the patient

Trial Locations

Locations (1)

UNC Lineberger Comprehensive Cancer Center; 🇺🇸 Chapel Hill, North Carolina, United States