The STEPP Study: Sensors To Evaluate Physical Performance

Oncology Clinical Trial

— STEPP  

Official title:

The STEPP Study: Sensors To Evaluate Physical Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03952767
• Other study ID #: LCCC 1851
• Status: Completed
• Phase: N/A
• Start date: April 24, 2019
• Est. completion date: August 30, 2022

Study information

• Verified date: October 2022
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Oncology

Intervention

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

Locations

Country	Name	City	State
United States	UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of mean steps per day recorded at home	At-home record of mean steps per day	18 months
Primary	Amount of mean sedentary activity time recorded at home	At-home record of minutes per day of mean sedentary activity time	18 months
Primary	Amount of Light activity time recorded at home	At-home record of minutes per day of light activity time per day	18 months
Primary	Amount of moderate activity time recorded at home	At-home record of minutes per day of moderate activity time	18 months
Primary	Amount of vigorous activity time recorded at home	At-home record of minutes per day of vigorous activity time	18 months
Primary	Self-Reported Karnofsky Performance Score (KPS)	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	18 months