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

Gland and Hormone Related Diseases

All Conditions

Behaviors and Mental Disorders

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Quality of Life

Ovarian Cancer

Ovarian Epithelial Cancer

Participants will enroll with a teammate (i.e. family or friend) and collaborate together. Teams will set a daily step goal, receive daily feedback on whether they achieved their goal, and receive a social incentive intervention.

Fitness trackers (e.g. Fitbit) are accelerometers that are worn on the wrist and tracks users' heart rate continuously in addition to steps, distance, calories, and active minutes

Fitness Tracker

The Way to Health platform is an automated information technology platform that integrates wireless devices, clinical trial randomization and enrollment processes, messaging (text, e-mail or voice), self-administered surveys, automatic transfers of financial incentives, and secure data capture for research purposes.

Social Incentive (Way to Health)

Alexi A. Wright, MD, MPH

This research study will test whether using wearable fitness trackers with a social incentive, delivered through a game-based mobile health intervention, increases physical activity and quality of life in ovarian cancer survivors.

Nearly 50% of ovarian cancer survivors experience poor quality of life, fatigue, and anxiety after completing surgery and chemotherapy to treat their disease. Moreover, many ovarian cancer survivors become deconditioned during treatment; 40% report significant drops in activity during the year after diagnosis, and only 20% meet the recommended guidelines for physical activity.

Interventional exercise studies are urgently needed to determine whether increasing physical activity improves outcomes in ovarian cancer survivors. In other cancers, physical activity improves quality of life and mental health, while reducing the risk of cancer recurrence and death. To date, however, most studies have focused on patients with curable breast and prostate cancers. The effects of physical activity on understudied populations, including ovarian cancer survivors, are unknown. Furthermore, although ovarian cancer survivors report an interest in participating in home-based walking programs, few formal programs exist.

Stepping into Survivorship is a single-arm study designed to test the effectiveness of a wearable fitness tracker with a game-based mobile health intervention that leverages social support to increase physical activity in ovarian cancer survivors. At the start of the study all participants will track their daily step counts using a wearable fitness tracker (e.g. Fitbit) to determine how many steps they walk in an average day. Next, they will set an increased step-goal and receive daily, individualized feedback based upon their performance.

Participants will also choose a team partner (i.e. family or friend) to receive a wearable fitness tracker and together they will track their steps, earning non-financial micro-incentives (e.g. points, levels, badges) when they achieve their collaborative goals. This game-based mobile health intervention is designed to enhance collaboration, accountability, peer support, and ultimately physical activity among ovarian cancer survivors and their friends/family members.

This research is being done to improve participants' quality of life. The investigators hope that the use of wearable fitness trackers with a game-based mobile health intervention will help participants increase their physical activity and improve quality of life.

Stepping Into Survivorship: Harnessing Behavioral Economics to Improve Quality of Life in Ovarian Cancer

Feasibility will be defined as ≥60% of patients who participate in the pilot study complete the 24-week intervention

Study burden: To what extent do you agree or disagree with: "Participating in this study placed a substantial burden on me." (Options: strongly agree, agree, neutral, disagree, strongly disagree)

To what extent do you agree or disagree with the following statements: "Participating in this study motivated me to increase my activity levels." Response options: strongly disagree, disagree, neutral, agree, strongly agree.

To compare the change in daily steps from end of baseline to 12 weeks (after the end of baseline) to estimate outcome parameters for future study

To compare the change in daily steps from end of baseline to 24 weeks (after the end of baseline) to estimate outcome parameters for future study

National Cancer Institute (NCI)

Dana-Farber Cancer Institute

Prinicipal Investigator

Participants will enroll with a teammate (i.e. family or friend) and collaborate together. Teams will set a daily step goal, receive daily feedback on whether they achieved their goal, and receive a social incentive intervention.

Fitness Tracker: Fitness trackers (e.g. Fitbit) are accelerometers that are worn on the wrist and tracks users' heart rate continuously in addition to steps, distance, calories, and active minutes

Social Incentive (Way to Health): The Way to Health platform is an automated information technology platform that integrates wireless devices, clinical trial randomization and enrollment processes, messaging (text, e-mail or voice), self-administered surveys, automatic transfers of financial incentives, and secure data capture for research purposes.

Fitness Tracker + Social Incentive Intervention

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Marital status

FIGO Stages range from I through IV. Median overall survival is greatest in early stage disease (IC and II) and worse is stage III-IV.

Staging is determined using criteria such as the size of the tumor, if the cancer has spread to nearby lymph nodes, and if the cancer has spread to distant sites or organs.

International Federation of Gynecology and Obstetrics (FIGO) stage

Histology

Eastern Cooperative Oncology Group Performance Status

0: Fully active; no performance restrictions.

1. Strenuous physical activity restricted; fully ambulatory and able to carry out light work.
2. Capable of all self-care but unable to carry out any work activities. Up and about \>50% of waking hours.

ECOG of 0 are considered to have fewer restrictions in their activities compared with those with an ECOG 1 or 2

ECOG PS

Time from treatment completion to intervention enrollment, days

Baseline daily steps

Self-selected family member or friend to participate as support partner

Teammate

* Single-arm pilot study without a control group
* Participants were recruited from a single academic center, were required to have a smartphone, and needed to be able to identify a teammate. This may have resulted in the selection of a more affluent, educated, and socially-connected population than is representative of ovarian cancer survivors nationwide.
* We did not specifically measure other types of activity not captured by Fitbits (e.g., swimming or biking).

Alexi Wright, MD, MPH

Participants who initially consented to the study

Feasibility of the Accelerometer + Social Support + Gamification

Acceptability

Perceived Effectiveness

Baseline (Day 1-14)

Intervention (Day 15-98)

Change in Daily Steps From Baseline to 12 Weeks

Baseline (Day 1-15)

Follow-up (Day 98-182)

Change in Daily Steps From Baseline 24 Weeks

Overall Study

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.

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
Stepping Into Survivorship: Harnessing Behavioral Economics to Improve Quality of Life in Ovarian Cancer	NCT03364673	Ovarian Cancer	Fitness Tracker Social Incentiv...	18 Years -	Dana-Farber Cancer Institute
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

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