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| ID | Type | Description | Link |
|---|---|---|---|
| JT 10656 | Other Identifier | JeffTrial Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monitoring Device | Device | Wear Fitbit Charge 3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Voichita Bar-Ad, MD | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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