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

Cedars-Sinai Medical Center

Status

Active, not recruiting

Conditions

Neoplasms

Cancer, Metastatic

Cancer

Treatments

Other: Wearable activity monitor

Study type

Observational

Funder types

Other

Identifiers

NCT03757182

IIT2018-19-GRESH-DIGISTEP

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.