CSMC, IIT2018-19-GRESH-DIGISTEP, Observational, Advanced Cancer, Wearable Activity Monitors

Summary

The purpose of this study is to examine the role of wrist-worn activity monitors (Fitbit) in the care of patients with advanced cancer. The study aims to determine whether changes in participants’ activity, as measured using the Fitbit, are related to changes in their clinical outcomes over the course of the study. Specifically, researchers would like to determine whether an increase or decrease in daily step counts is associated with an improvement or worsening of performance status, as rated by the patient’s oncologist. Researchers will also examine relationships between average weekly Fitbit activity and self-reported symptoms including pain, fatigue, physical functioning, emotional well-being, and sleep quality.

The Fitbit Charge HR is a commercially available biosensor (a device that tracks steps, movement or other activities), but this device has not been approved by the U.S. Food and Drug Administration (FDA) for medical use.


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).
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Study Location(s)

Cedars-Sinai Cancer at SOCC

More about this Clinical Trial

Full Title

Digitally-captured Step counts for Evaluating Performance Status in Advanced Cancer Patients: A single cohort, prospective trial

Details
Disease Type/Condition

Anus, Bones and Joints, Brain and Nervous System, Breast, Cervix, Colon, Corpus Uteri, Esophagus, Eye and Orbit, Hodgkin's Lymphoma, Ill-Defined Sites, Kidney, Larynx, Leukemia, not otherwise specified, Leukemia, other, Lip, Oral Cavity and Pharynx, Liver, Lung, Lymphoid Leukemia, Melanoma, Multiple Myeloma, Non-Hodgkin's Lymphoma, Other Digestive Organ, Other Endocrine System, Other Female Genital, Other Hematopoietic, Other Male Genital, Other Respiratory and Intrathoracic Organs, Other Skin, Other Urinary, Ovary, Pancreas, Prostate, Rectum, Small Intestine, Soft Tissue, Stomach, Thyroid, Unknown Sites, Urinary Bladder

Principal Investigator

Gresham, Gillian

Co-Investigators

Andrew Hendifar, Arash Asher, Bobbie Jo Rimel, Brennan Spiegel, Christine Walsh, Edwin Posadas, Jun Gong, Robert Figlin

Age Group

Adult

Phase

N/A (Cancer Control)

IRB Number

Pro00055271

ClinicalTrials.gov ID

NCT03757182

Key Eligibility
ClinicalTrials.gov

Contact
Email
cancer.trial.info@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Anus, Bones and Joints, Brain and Nervous System, Breast, Cervix, Colon, Corpus Uteri, Esophagus, Eye and Orbit, Hodgkin's Lymphoma, Ill-Defined Sites, Kidney, Larynx, Leukemia, not otherwise specified, Leukemia, other, Lip, Oral Cavity and Pharynx, Liver, Lung, Lymphoid Leukemia, Melanoma, Multiple Myeloma, Non-Hodgkin's Lymphoma, Other Digestive Organ, Other Endocrine System, Other Female Genital, Other Hematopoietic, Other Male Genital, Other Respiratory and Intrathoracic Organs, Other Skin, Other Urinary, Ovary, Pancreas, Prostate, Rectum, Small Intestine, Soft Tissue, Stomach, Thyroid, Unknown Sites, Urinary Bladder

Principal Investigator

Gresham, Gillian

Age Group

Adult

Phase

N/A (Cancer Control)

IRB Number

IIT2018-19-GRESH-DIGISTEP

ClinicalTrials.gov ID

NCT03757182

Key Eligibility
ClinicalTrials.gov

Contact
Email
cancer.trial.info@cshs.org
Want to join the study or
learn more?