Clinical trial NCT03757182: Digitally-Captured Step Counts for Evaluating Performance Status in Advanced Cancer Patients
Official title: Digitally-Captured Step Counts for Evaluating Performance Status in Advanced Cancer Patients: A Single Cohort, Prospective Trial
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer
Cancer, Metastatic
Neoplasms
Keywords: Wearable device
Fitness tracker
Wearable activity monitor
Biosensor
Performance Status
Activity Monitoring
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stage 3/4 advanced cancer patients being seen for treatment at 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.

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.

Eligibility 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
* Informed consent obtained from subject and ability for subject to comply with the requirements of the study.

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.

Primary outcomes:
measure: Absolute change in average step counts at 8 weeks from baseline
timeFrame: 8 weeks
measure: Absolute change in provider-assessed ECOG Performance Status at 8 weeks from baseline
timeFrame: 8 weeks
Secondary outcomes:
measure: Absolute change in patient-reported physical function at 8 weeks from baseline
timeFrame: 8 weeks
measure: Patient weekly distress levels up to 8 weeks from baseline
timeFrame: 8 weeks
measure: Adherence to wearing the device for the specified study period
timeFrame: 8 weeks
measure: Change in frailty status from baseline to end-of-study visit (up to 8 weeks from baseline)
timeFrame: 8 weeks
measure: Occurrence of grade 3 or 4 SOC cancer-related adverse events or chemotoxicities and hospitalizations occurring from baseline up to 12 weeks
timeFrame: up to 12 weeks
measure: Overall survival up to 1 year from end-of-study
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Gillian Gresham, PhD
role: PRINCIPAL_INVESTIGATOR
References: