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

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.

Study Overview

• Status: Recruiting
• Conditions: Neoplasms; Cancer; Cancer, Metastatic
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center
      • Sub-Investigator: Andrew Hendifar, MD
      • Sub-Investigator: Edwin Posadas, MD
      • Sub-Investigator: Stephen Freedland, PhD
      • Sub-Investigator: BJ Rimel, MD
      • Sub-Investigator: Brennan Spiegel, MD
      • Sub-Investigator: Arash Asher, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Stage 3/4 advanced cancer patients being seen for treatment at Cedars-Sinai Medical Center.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute change in average step counts at 8 weeks from baseline	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	8 weeks
Absolute change in provider-assessed ECOG Performance Status at 8 weeks from baseline	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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute change in patient-reported physical function at 8 weeks from baseline	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.	8 weeks
Patient weekly distress levels up to 8 weeks from baseline	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.	8 weeks
Adherence to wearing the device for the specified study period	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	8 weeks
Change in frailty status from baseline to end-of-study visit (up to 8 weeks from baseline)	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).	8 weeks
Occurrence of grade 3 or 4 SOC cancer-related adverse events or chemotoxicities and hospitalizations occurring from baseline up to 12 weeks	AEs will be rated using CTCAE v5	up to 12 weeks
Overall survival up to 1 year from end-of-study	Occurrence of death from any cause	up to 1 year

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2018
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: November 26, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Activity Monitoring; Wearable device; Biosensor; Fitness tracker; Wearable activity monitor; Performance Status
• Other Study ID Numbers: IIT2018-19-GRESH-DIGISTEP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: IPD available upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No