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Digitally-Captured Step Counts for Evaluating Performance Status in Advanced Cancer Patients (DigiSTEPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03757182
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Gillian Gresham, Cedars-Sinai Medical Center

Brief Summary:
The purpose of this study is to examine the relationships between objectively measured physical activity and provider-assessed and patient-reported functional outcomes in patients with advanced cancer. Findings from this study will help us better understand how change in daily physical activity, as measured using the wearable activity monitor, is related to change in a patient's functional status and clinical condition.

Condition or disease Intervention/treatment
Cancer Cancer, Metastatic Neoplasms Other: Wearable activity monitor

Detailed Description:
Patients diagnosed with stage 3/ 4 cancer will be enrolled. After providing informed consent, patients will be asked to wear a FitBit Charge HR continuously for 8 weeks with the option to continue wearing the monitor for up to a year after end-of-study. Baseline assessments include a physical exam, medical history, and frailty assessment. The attending oncologist will rate the patient's performance status (ECOG PS) at baseline and 8-weeks follow-up. Patient-reported outcomes (self-reported physical function, fatigue, sleep, emotional distress) will be assessed weekly using NIH PROMIS from baseline up to 8 weeks from end-of-study. They will also be collected at 1 year follow-up. Wearable activity monitor data will be summarized each week for 8 weeks, and then again at 1 year follow-up. Physical activity data (number of steps, stairs climbed, active minutes, heart rate, and sleep duration) will be collected and analyzed at end-of-study (up to 1 year from end-of-study). Overall survival will also be assessed up to 1 year from end-of-study. Absolute change in physical activity levels will be correlated with change in performance status and occurrence of AEs and death to better understand the role of remote activity monitoring in cancer patients.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Digitally-Captured Step Counts for Evaluating Performance Status in Advanced Cancer Patients: A Single Cohort, Prospective Trial
Actual Study Start Date : December 5, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Group/Cohort Intervention/treatment
Wearable activity monitor
Continuous activity monitoring with Fitbit Charge HR from baseline to up to 1 year from end-of-study.
Other: Wearable activity monitor
Continuous monitoring of physical activity including step counts, sleep, heart rate, with consumer-based wearable activity monitor (Fitbit Charge HR)
Other Names:
  • Fitness tracker
  • Wearable device
  • Biosensor




Primary Outcome Measures :
  1. Absolute change in average step counts at 8 weeks from baseline [ Time Frame: 8 weeks ]
    Change will be calculated based on difference in average weekly step count at baseline from the average weekly step count at end-of-study visit

  2. Absolute change in provider-assessed ECOG Performance Status at 8 weeks from baseline [ Time Frame: 8 weeks ]
    Change in performance status will be calculated based on difference in provider-assessed Eastern Cooperative Oncology Group (ECOG) performance status at end-of-study visit and baseline ECOG. ECOG Performance Status is rated based on a 5-point scale where a score of 0 indicates best performance status and 5 indicates death. Only one rating of ECOG PS by provider is completed at each timepoint.


Secondary Outcome Measures :
  1. Absolute change in patient-reported physical function at 8 weeks from baseline [ Time Frame: 8 weeks ]
    Physical function will be assessed using the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) short form, which includes 20 items and a range of 1 (low physical function) to 5 (high physical function). The total score will be calculated and converted into a standardized t-score will be calculated based on a standard cancer population with a mean of 50 and SD of 10.

  2. Patient weekly distress levels up to 8 weeks from baseline [ Time Frame: 8 weeks ]
    Distress will be measured using using NIH Patient-Reported Outcomes Measurement Information System (PROMIS), which includes short forms: emotional distress, sleep quality, pain, and fatigue. Items range from 1 (worse outcome) and 5 (best outcome) where a total score will be calculated and converted into standardized t-scores.

  3. Adherence to wearing the device for the specified study period [ Time Frame: 8 weeks ]
    A patient is considered adherent if they wear the device at least 10 hours per day for at least 4 of 7 days prior to each study timepoint

  4. Change in frailty status from baseline to end-of-study visit (up to 8 weeks from baseline) [ Time Frame: 8 weeks ]
    Score calculated based on total number of frailty characteristics present using Fried's validated Frailty index. Characteristics of frailty include shrinking (weight loss), weakness (grip strength), poor endurance, exhaustion, slowness, and low activity. The minimal score is 0, indicating absence of frailty, and the highest is 5. Frailty index categories include absence of frailty (score of 0), pre-frail or intermediate frail (1-2 criteria) and frail (>3 criteria present).

  5. Occurrence of grade 3 or 4 SOC cancer-related adverse events or chemotoxicities and hospitalizations occurring from baseline up to 12 weeks [ Time Frame: up to 12 weeks ]
    AEs will be rated using CTCAE v5

  6. Overall survival up to 1 year from end-of-study [ Time Frame: up to 1 year ]
    Occurrence of death from any cause



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Stage 3/4 advanced cancer patients being seen for treatment at Cedars-Sinai Medical Center.
Criteria

Inclusion Criteria:

  • Diagnosis of advanced (stage 3 or 4) cancer of any type
  • Ambulatory (use of walking aids, such as cane and rollator, is acceptable)
  • Access to a device that has the capability to sync to the Fitbit
  • Expected to have standard of care oncology appointments at least once every 8 weeks (+/-7 days).
  • Have an understanding, ability, and willingness to fully comply with study procedures and restrictions
  • English or Spanish speaking
  • Ability to consent

Exclusion Criteria:

  • Allergy to surgical steel or elastomer/rubber
  • Using a pacemaker, implantable cardiac defibrillator, neurostimulator, implantable hearing aids, cochlear implants, or other electronic medical equipment. However, removable hearing aids are permitted.

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): NCT03757182


Contacts
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Contact: Gillian Gresham, PhD 310-423-3341 gillian.gresham@cshs.org
Contact: Rachel Baynes, MA 310-423-1323 rachel.baynes@cshs.org

Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Gillian Gresham    310-423-3341    Gillian.Gresham@cshs.org   
Principal Investigator: Stephen Freedland, PhD         
Sub-Investigator: BJ Rimel, MD         
Sub-Investigator: Brennan Spiegel, MD         
Sub-Investigator: Jun Gong, MD         
Sub-Investigator: Arash Asher, MD         
Sub-Investigator: Andrew Hendifar, MD         
Sub-Investigator: Christine Walsh, MD         
Sub-Investigator: Edwin Posadas, MD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Stephen Freedland, MD Cedars-Sinai Medical Center

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Responsible Party: Gillian Gresham, co-Principal Investigator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03757182    
Other Study ID Numbers: IIT2018-19-GRESH-DIGISTEP
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD available upon request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gillian Gresham, Cedars-Sinai Medical Center:
Wearable device
Fitness tracker
Wearable activity monitor
Biosensor
Performance Status
Activity Monitoring