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

Conditions:Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:December 5, 2018
End Date:December 31, 2020
Contact:Gillian Gresham, PhD

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Digitally-Captured Step Counts for Evaluating Performance Status in Advanced Cancer Patients: A Single Cohort, Prospective Trial

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.

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

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, hearing aids,
cochlear implants, or other electronic medical equipment
We found this trial at
8700 Beverly Blvd # 8211
Los Angeles, California 90048
Principal Investigator: Stephen Freedland, PhD
Phone: 310-967-4336
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
Los Angeles, CA
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