Remote Activity Monitored by Fitbit Charge 2 in Investigating Daily Step and Sleep Data in Participants With Head and Neck Cancer Undergoing Radiation Therapy
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/9/2018 |
| Start Date: | April 20, 2018 |
| End Date: | March 2020 |
| Contact: | Voichita Bar-Ad, MD |
| Email: | voichita.bar-ad@jefferson.edu |
| Phone: | 215-955-5289 |
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
This pilot trial studies remote activity monitored by Fitbit Charge 2 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 2, 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.
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 2, 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.
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.
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
Exclusion Criteria:
- Patients who cannot read or speak English
- Patients who are not candidates for RT/CRT treatment
We found this trial at
1
site
Philadelphia, Pennsylvania 19107
Phone: 215-955-5289
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