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Active, Not Recruiting

NCT Number: NCT03757182

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cancer Cancer, Metastatic Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wearable Activity Monitor

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

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

Acronym: DigiSTEPS

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Nov 28, 2018
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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