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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-20

Study Completion Date

2021-10-20

Brief Summary

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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.

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Detailed Description

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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

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Head and Neck Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Device Feasibility (Fitbit Charge 3)

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

Group Type EXPERIMENTAL

Monitoring Device

Intervention Type DEVICE

Wear Fitbit Charge 3

Interventions

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Monitoring Device

Wear Fitbit Charge 3

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No