The STEPP Study: Sensors To Evaluate Physical Performance

NCT03952767 | Completed DMC

• 1 other identifier: LCCC 1851
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Oncology

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Digital Physical Measures and Survey Assessments

EXPERIMENTAL

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

Interventions

Digital Physical Measures and Survey Assessments OTHER

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

Digital Physical Measures and Survey Assessments

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Pfizer: collaborator

Study Sites (1)

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• Karahanoglu FI, Jensen CE, Cai X, Santamaria M, Psaltos D, Messere A, Demanuele C, Stone J, Tarachandani A, Adamowicz L, Muss H, Wood WA. Improved functional assessment in cancer patients using home-based digital technologies. Sci Rep. 2025 May 21;15(1):17638. doi: 10.1038/s41598-025-02401-4.

  PMID: 40399391 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 16, 2019
• Study Start: April 24, 2019
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2022
• Last Updated: October 25, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)