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Completed

NCT Number: NCT03952767

The STEPP Study: Sensors To Evaluate Physical Performance

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

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Key information

Conditions

Oncology Neoplasms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Amount of mean steps per day recorded at home

    Time frame: 18 months

    At-home record of mean steps per day

  2. Amount of mean sedentary activity time recorded at home

    Time frame: 18 months

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

  3. Amount of Light activity time recorded at home

    Time frame: 18 months

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

  4. Amount of moderate activity time recorded at home

    Time frame: 18 months

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

  5. Amount of vigorous activity time recorded at home

    Time frame: 18 months

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

  6. Self-Reported Karnofsky Performance Score (KPS)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • Pfizer

Registry information

Acronym: STEPP

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
May 16, 2019
Registry last updated
Oct 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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