The STEPP Study: Sensors To Evaluate Physical Performance

UNC Lineberger Comprehensive Cancer Center63 enrolled

Overview

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

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Oncology

Interventions

Digital Physical Measures and Survey AssessmentsOTHER

Data from at home and in clinic visits will assess physical function and survey data will be collected

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (1)

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

Amount of mean steps per day recorded at home

At-home record of mean steps per day

Time frame: 18 months

Amount of mean sedentary activity time recorded at home

At-home record of minutes per day of mean sedentary activity time

Time frame: 18 months

Amount of Light activity time recorded at home

At-home record of minutes per day of light activity time per day

Time frame: 18 months

Amount of moderate activity time recorded at home

At-home record of minutes per day of moderate activity time

Time frame: 18 months

Amount of vigorous activity time recorded at home

At-home record of minutes per day of vigorous activity time

Time frame: 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

Time frame: 18 months

Data from ClinicalTrials.gov

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