Continuous activity monitoring with Fitbit Charge HR from baseline to up to 1 year from end-of-study.

Continuous monitoring of physical activity including step counts, sleep, heart rate, with consumer-based wearable activity monitor (Fitbit Charge HR)

Wearable activity monitor

Gillian Gresham, PhD

Eileen Liu

Stephen Freedland, PhD

BJ Rimel, MD

Brennan Spiegel, MD

Jun Gong, MD

Arash Asher, MD

Andrew Hendifar, MD

Christine Walsh, MD

Edwin Posadas, MD

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 patients.

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

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

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

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.

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.

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.

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

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).

Cedars-Sinai Medical Center

Principal Investigator

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Nervous System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Uterine Cervical Neoplasms

Brain Neoplasms

Head and Neck Neoplasms

Lung Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Pharmaceutical Solutions

All Drugs and Chemicals

Subjects randomized to the control arm will wear activity trackers but will have no specific instructions to increase their activity levels.

Subjects randomized to the experimental arm will be instructed to meet the customized daily step count goals that are displayed on their fitness trackers. Patients who fail to meet their step count goal for three consecutive days will be contacted by a study coordinator and reminded to try to meet the activity goals. If the patient reports that his or her activity is limited by treatment-related toxicities, the patient's treating physicians will be notified to ensure that supportive care needs are being met.

Patients will be instructed to meet the daily step count goal displayed on their fitness tracker. If goal is not being met, study team will intervene and reinforce the importance of meeting this goal. Intervention will include a conversation with the patient, led by a study coordinator, to identify any challenges present in meeting the prescribed goal. Solutions to such challenges may be offered by the coordinator or necessary provider, such as a dietitian, when applicable.

Pedometer-based Walking Program

Nitin Ohri, MD

By utilizing fitness trackers, this study aims to demonstrate that a simple walking program improves patients' ability to tolerate curative concurrent chemoradiotherapy without treatment interruption.

Patients will be given a commercially available fitness tracker to wear continuously throughout the course of the study. Per this study's inclusion criteria, all patients will be treated with concurrent chemoradiotherapy for a malignancy of the brain, head and neck region, lung, gastrointestinal tract, or cervix. Patients will be randomized to one of two arms: an experimental arm, where they will be instructed to meet a daily, customized step count goal, or a control arm where they will wear activity trackers but be given no specific instructions to increase their activity levels. Patients in the experimental arm who fail to meet their step count goal for three consecutive days will be contacted by a study coordinator and reminded to try to meet the activity goals. If the patient reports that his or her activity is limited by treatment-related toxicities, the patient's treating physicians will be notified to ensure that supportive care needs are being met. With such a program, this study aims to demonstrate the potential to improve patients' ability to tolerate curative concurrent chemoradiotherapy without treatment interruption.

A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery

A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery: A Randomized Trial

The primary endpoint of this study is missing two or more scheduled external beam radiotherapy treatments. Treatments that are cancelled due to national holidays, inclement weather, or machine issues will not count towards this endpoint.

Step counts will be recorded and measured daily from patients' fitness trackers.

Toxicities will be evaluated each week and scored using CTCAE version 4.03.

Using the EMR, a record will be kept indicating the number of times each patient visits the emergency room.

Using the EMR, a record will be kept indicating the number of times each patient is hospitalized.

Scores will be calculated based on serum albumin and C-reactive protein levels.

Disease progression or recurrence, to be scored by treating physicians based on available clinical and imaging data

Survival data will be kept for all patients on study throughout treatment and follow-ups.

Albert Einstein College of Medicine

Rare Diseases

Stomach Neoplasms

Esophageal Neoplasms

Esophageal Diseases

Stomach Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Stomach Cancer

Esophageal Cancer

1. Enhanced Supportive Care - Status Checks Would occur everyday during treatment when a patient is deemed high-risk based on activity level. Other Names: •Daily Status Checks
2. Enhanced Supportive Care - Referrals On an as-need basis, high risk patients can be referred to our nutritionist or palliative care doctor. Other Names: •Referrals

Would occur everyday during treatment when a patient is deemed high-risk.

Enhanced Supportive Care - Status Checks

On an as-need basis, high risk patients can be referred to our nutritionist or palliative care doctor.

Enhanced Supportive Care - Referrals

This study will aim to demonstrate that implementation of a rapid, multidisciplinary supportive care program for patients receiving chemoradiotherapy who are deemed to be at high risk for hospitalization based on real-time pedometer data will reduce the rate of hospitalization during chemoradiotherapy or within four weeks of radiotherapy completion.

Primary Objective

* To demonstrate that implementation of a rapid, multidisciplinary supportive care program for patients receiving chemoradiotherapy who are deemed to be at high risk for hospitalization based on real-time pedometer data will reduce the rate of hospitalization during chemoradiotherapy or within four weeks of radiotherapy completion.

Secondary Objectives

* To demonstrate the feasibility of a program of rapid, multidisciplinary supportive care triggered by real-time pedometer data.
* To characterize the interventions enacted by our multidisciplinary supportive care team.
* To explore if interventions enacted by our multidisciplinary team for patients with low recent step counts lead to increased step counts in subsequent weeks compared to historical controls.
* To collect biospecimens for future correlative studies examining associations between blood/urine biomarkers and patient activity levels.

Real-time Activity Monitoring to Prevent Admissions During RadioTherapy

The primary endpoint of this study is hospitalization during chemoradiotherapy or within 4 weeks after completion of radiotherapy.

Activation of the enhanced supportive care protocol (multidisciplinary evaluation and daily nursing/physician visits) based on recent step count data.

Clinician visits and supportive care measures that result from activation of the enhanced supportive care protocol

Patient-reported quality of life scores, measured using the EORTC QLC-C30 questionnaire.

Treatment-related toxicities, scored using CTCAE version 4.03.

Modified Glasgow Prognostic Score will be measured as a function of the C-Reactive Protein and Albumin levels that are collected throughout the study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Digitally-Captured Step Counts for Evaluating Performance Status in Advanced Cancer Patients	NCT03757182	Cancer Cancer, Metasta... Neoplasms	Wearable activi...	18 Years -	Cedars-Sinai Medical Center
A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery	NCT03115398	Brain Cancer Head and Neck C... Lung Cancer Gastrointestina... Cervical Cancer	Pedometer-based...	18 Years -	Albert Einstein College of Medicine
Real-time Activity Monitoring to Prevent Admissions During RadioTherapy	NCT03102229	Cancer of the H... Cancer of Lung Cancer of Esoph... Cancer of Stoma...	Enhanced Suppor... Enhanced Suppor...	18 Years -	Albert Einstein College of Medicine
Real-time Activity Monitoring to Prevent Admissions During RadioTherapy	NCT03102229	Cancer of the H... Cancer of Lung Cancer of Esoph... Cancer of Stoma...	Enhanced Suppor... Enhanced Suppor...	18 Years -	Albert Einstein College of Medicine

Spots Global Cancer Trial Database for activity monitoring