Remote Activity Monitored by Fitbit Charge 3 in Investigating Daily Step and Sleep Data in Participants With Head and Neck Cancer Undergoing Radiation Therapy

NCT03489252 | Completed DMC

• 2 other identifiers: 17D.653JT 10656
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot trial studies remote activity monitored by Fitbit Charge 3 in investigating daily step and sleep data in participants with head and neck cancer who are undergoing radiation therapy. A wearable remote activity tracking device, such as the Fitbit Charge 3, may help to detect early signs of treatment or disease-related symptoms, improve quality of life, decrease emergency room visits, and decrease hospitalizations in participants with head and neck cancer.

Conditions

Head and Neck Carcinoma

Outcome Measures

Primary Outcomes (1)

• Percentage of time patients wear the Fitbit Charge 3 device (compliance)

  Daily compliance with remote activity monitoring (RAM) will be defined as wearing the device for 19/24 hours daily (80% daily use). Overall study period compliance will be defined as usage of the device for at least 70% of the days under observation where it should have been worn. The overall study period compliance rate along with a one-sided exact 95% confidence interval will be estimated.

  Through study completion, an average of 3 months

Study Arms (1)

Device Feasibility (Fitbit Charge 3)

EXPERIMENTAL

Participants wear the Fitbit Charge 3 device from the time of CT simulation for RT planning throughout the entire RT course.

Device: Monitoring Device

Interventions

Monitoring Device DEVICE

Wear Fitbit Charge 3

Device Feasibility (Fitbit Charge 3)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects have head and neck cancer as defined in history and physical
• Patients are eligible to be treated with RT or CRT and plan to start treatment
• Patients are capable of giving informed consent
• Patients must be able to read and/or to speak English
• Patients who are 18 years of age or older
• Women of reproductive potential should have a negative serum or urine pregnancy test within the week prior to radiation CT planning scan

You may not qualify if:

• Patients who cannot read or speak English
• Patients who are not candidates for RT/CRT treatment.
• Women of childbearing potential who are pregnant or breastfeeding

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Interventions

Monitoring, Physiologic

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Voichita Bar-Ad, MD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: April 5, 2018
• Study Start: April 20, 2018
• Primary Completion: October 14, 2021
• Study Completion: October 20, 2021
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

US (1)