Head and Neck Carcinoma
Conditions
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.
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.
Interventions
DEVICEMonitoring Device
Wear Fitbit Charge 3
Sponsors
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of time patients wear the Fitbit Charge 3 device (compliance) | Through study completion, an average of 3 months | 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. |
Countries
United States
Outcome results
None listed