NCT03489252

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

RAMP (Remote Activity Monitoring Pilot): A Feasibility Study Investigating Daily Step and Sleep Data in Combination With Electronic Patient-Reported Outcomes in Adult Patients With Head and Neck Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. Determine compliance with remote activity monitoring (RAM) in patients receiving radiotherapy (RT) or chemoradiotherapy (CRT) for head and neck cancer (HNC). SECONDARY OBJECTIVES: I. Evaluate feasibility of recruitment to the Remote Activity Monitoring Pilot (RAMP). II. Investigate patient acceptability of RAM. III. Evaluate compliance with electronic patient-reported outcomes (ePROs) in this patient population. IV. Estimate the change in average daily steps associated with a one-unit change in health score as collected on ePRO analysis (analyze associations between RAM data and ePROs). V. Investigate correlations among step data, quality of life (QOL), and emergency room (ER) visits/hospitalizations.

Conditions

• Head and Neck Carcinoma

Interventions

Type	Name	Description
DEVICE	Monitoring Device	Wear Fitbit Charge 3

Timeline

• Start date: 2018-04-20
• Primary completion: 2021-10-14
• Completion: 2021-10-20
• First posted: 2018-04-05
• Last updated: 2025-08-22

Locations

1 site across 1 country: United States