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

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ClinicalTrials.gov Identifier: NCT03952767
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : July 19, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

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 Not Applicable

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)


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
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 : April 24, 2019
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

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




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952767


Contacts
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Contact: Eve Hickey (919)9628376 genevieve_hickey@med.unc.edu

Locations
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United States, North Carolina
UNC Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Eve Hickey    919-962-8376    genevieve_hickey@med.unc.edu   
Contact: Amy Garrett         
Principal Investigator: William Wood, MD         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Pfizer

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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03952767     History of Changes
Other Study ID Numbers: LCCC 1851
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No