Head and Neck CarcinomaNCT03489252
Remote Activity Monitored by Fitbit Charge 3 in Investigating Daily Step and Sleep Data in Participants With Head and Neck Cancer Undergoing Radiation Therapy
A study testing Monitoring Device in people with Head and Neck Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Carcinoma
- What is being tested?
- Monitoring Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2018to 20 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine compliance with remote activity monitoring (RAM) in patients receiving radiotherapy (RT) or chemoradiotherapy (CRT) for head and neck cancer (HNC).
SECONDARY OBJECTIVES:
- 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).
- Investigate correlations among step data, quality of life (QOL), and emergency room (ER) visits/hospitalizations.
- Conditions
- Head and Neck Carcinoma
- Being tested
- Monitoring Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring DeviceDevice
Wear Fitbit Charge 3
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Monitoring Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start20 Apr 2018
- Primary completion14 Oct 2021
- Study completion20 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Voichita Bar-Ad, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489252
- Sponsor's protocol ID
- 17D.653
- Other IDs
- JT 10656
- Status last verified
- Aug 2025
- First submitted
- 21 Mar 2018
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03489252
- Acronym / sponsor ID
- 17D.653
- Conditions
- Head and Neck Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 14 Oct 2021 (actual)
- Study completion
- 20 Oct 2021 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determine compliance with remote activity monitoring (RAM) in patients receiving radiotherapy (RT) or chemoradiotherapy (CRT) for head and neck cancer (HNC).
SECONDARY OBJECTIVES:
- 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).
- Investigate correlations among step data, quality of life (QOL), and emergency room (ER) visits/hospitalizations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device Feasibility (Fitbit Charge 3) | Experimental | Device: Monitoring DeviceParticipants wear the Fitbit Charge 3 device from the time of CT simulation for RT planning throughout the entire RT course. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring DeviceWear Fitbit Charge 3 | Device | Device Feasibility (Fitbit Charge 3) |
Primary outcome
Percentage of time patients wear the Fitbit Charge 3 device (compliance)
Time frame: Through study completion, an average of 3 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Voichita Bar-Ad, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring Device in people with Head and Neck Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of time patients wear the Fitbit Charge 3 device (compliance) (time frame: Through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.