Clinical trial NCT03489252: Remote Activity Monitored by Fitbit Charge 3 in Investigating Daily Step and Sleep Data in Participants With Head and Neck Cancer Undergoing Radiation Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Carcinoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of time patients wear the Fitbit Charge 3 device (compliance)
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Voichita Bar-Ad, MD
role: PRINCIPAL_INVESTIGATOR
References: