The STEPP Study: Sensors To Evaluate Physical Performance (STEPP)

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

Study Overview

• Status: Completed
• Conditions: Oncology
• Intervention / Treatment: Other: Digital Physical Measures and Survey Assessments

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 Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Lineberger Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Digital Physical Measures and Survey Assessments; Digital physical measure data will be collected in clinic and at home and survey assessments will be collected	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of mean steps per day recorded at home	At-home record of mean steps per day	18 months
Amount of mean sedentary activity time recorded at home	At-home record of minutes per day of mean sedentary activity time	18 months
Amount of Light activity time recorded at home	At-home record of minutes per day of light activity time per day	18 months
Amount of moderate activity time recorded at home	At-home record of minutes per day of moderate activity time	18 months
Amount of vigorous activity time recorded at home	At-home record of minutes per day of vigorous activity time	18 months
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

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: Pfizer

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 24, 2019
• Primary Completion (ACTUAL): August 30, 2021
• Study Completion (ACTUAL): August 30, 2022

Study Registration Dates

• First Submitted: May 13, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (ACTUAL): May 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 21, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: LCCC 1851

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No