The STEPP Study: Sensors To Evaluate Physical Performance

NCT03952767

Last updated date
Study Location
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Oncology
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-99 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

OncologyThe STEPP Study: Sensors To Evaluate Physical Performance
NCT03952767
  1. Chapel Hill, North Carolina
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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
 (submitted: May 14, 2019)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2021
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
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 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP