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

S

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status

Completed

Conditions

Head and Neck Carcinoma

Treatments

Device: Monitoring Device

Study type

Interventional

Funder types

Other

Identifiers

NCT03489252
17D.653

Details and patient eligibility

About

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.

Full 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.

Enrollment

41 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

41 participants in 1 patient group

Device Feasibility (Fitbit Charge 3)
Experimental group
Description:
Participants wear the Fitbit Charge 3 device from the time of CT simulation for RT planning throughout the entire RT course.
Treatment:
Device: Monitoring Device

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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