The STEPP Study: Sensors To Evaluate Physical Performance
NCT03952767
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
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.
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.
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- Chapel Hill, North Carolina
| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title ICMJE | The STEPP Study: Sensors To Evaluate Physical Performance | ||||
| Official Title ICMJE | The STEPP Study: Sensors To Evaluate Physical Performance | ||||
| Brief Summary | This study assesses the association between digital functional measures of physical and patient-reported standard onocological assessments, like Karnofsky Performance Score (KPS). | ||||
| 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) | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Other | ||||
| Condition ICMJE | Oncology | ||||
| Intervention ICMJE | 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 | ||||
| Study Arms ICMJE | 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 Intervention: Other: Digital Physical Measures and Survey Assessments | ||||
| Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 90 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | August 30, 2022 | ||||
| Estimated Primary Completion Date | August 30, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Signed and dated informed consent and HIPPA. Exclusion Criteria:
| ||||
| Sex/Gender ICMJE |
| ||||
| Ages ICMJE | 18 Years to 99 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03952767 | ||||
| Other Study ID Numbers ICMJE | LCCC 1851 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
| ||||
| IPD Sharing Statement ICMJE |
| ||||
| Responsible Party | UNC Lineberger Comprehensive Cancer Center | ||||
| Study Sponsor ICMJE | UNC Lineberger Comprehensive Cancer Center | ||||
| Collaborators ICMJE | Pfizer | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | UNC Lineberger Comprehensive Cancer Center | ||||
| Verification Date | April 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||