The STEPP Study: Sensors To Evaluate Physical Performance

Sponsor

UNC Lineberger Comprehensive Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03952767

Collaborator

Pfizer (Industry)

Enrollment

Location

Arm

40.2

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Oncology	Other: Digital Physical Measures and Survey Assessments	N/A

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:

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

The STEPP Study: Sensors To Evaluate Physical Performance

Actual Study Start Date :

Apr 24, 2019

Actual Primary Completion Date :

Aug 30, 2021

Anticipated Study Completion Date :

Aug 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Amount of mean steps per day recorded at home [18 months]
At-home record of mean steps per day
Amount of mean sedentary activity time recorded at home [18 months]
At-home record of minutes per day of mean sedentary activity time
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Signed and dated informed consent and HIPPA.

Exclusion Criteria:

Subjects using investigational/experimental products.
Has dementia, altered mental status, or any psychiatric or co-morbid condition prohibiting the understanding or rending of informed consent.
Unable or unwilling to complete physical performance assessments including the at-home wearable device for 14 days.
Unable to speak English.
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.
Subjects who are allergic to silicone or adhesives. Subjects with cardiac pacemakers, electronic pumps or any other implanted medical devices.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina	United States	27599

Sponsors and Collaborators

UNC Lineberger Comprehensive Cancer Center
Pfizer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

UNC Lineberger Comprehensive Cancer Center

ClinicalTrials.gov Identifier:

NCT03952767

Other Study ID Numbers:

LCCC 1851

First Posted:

May 16, 2019

Last Update Posted:

Oct 22, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Oct 22, 2021