Cancer of Head and NeckFITBITNCT03574870
Wearable Sensor for Biometrics During Locoregional Therapy for Head and Neck Cancer
A study testing wearable sensor in people with Cancer of Head and Neck, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The investigator will seek to determine the feasibility of wearable biometric sensors to acquire high resolution biometric data, including heart rate and activity level (i.e. steps) for patients undergoing radiation therapy and surgery, with or without postoperative radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Cancer of Head and Neck
- What is being tested?
- wearable sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2017to 31 Dec 2019
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-proven malignancy requiring chemoradiation therapy to the head and neck, OR primary surgery to the head and neck, with or without adjuvant radiotherapy or chemoradiotherapy.
- Age ≥ 18 years.
- Performance status ECOG 0-2
- Per typical radiotherapy policy, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry.
- 3.1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
Show all 11Show fewer
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Concurrent chemotherapy is required for definitive radiotherapy patients
- Hypofractionated or stereotactic body radiation therapy is not permitted
- Ability to understand and the willingness to sign a written informed consent
- Willingness to download the Fitbit App to a personal mobile device
Who cannot join
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: Feasibility Study of a Wearable Sensor for Acquisition of Biometric Data in Head and Neck Cancer Patients During Locoregional Therapy
The investigator will seek to determine the feasibility of wearable biometric sensors to acquire high resolution biometric data, including heart rate and activity level (i.e. steps) for patients undergoing radiation therapy and surgery, with or without postoperative radiotherapy.
Read the detailed description
Active cancer treatment such as surgery, chemotherapy or radiotherapy can cause side effects or toxicities, which, if untreated, can lead to poorer quality of life, decreased patient well-being, and worse clinical outcomes. Routine monitoring of patients while under active treatment can entail the routine practice of clinic visits at regular intervals with the acquisition of vital signs, routine laboratory testing, patient-reported outcome surveys, and face-to-face interaction with their physician.
In recent years, the availability of commercially-available wearable fitness sensors has allowed end-users to monitor their fitness progress and activity levels. These devices depend on small sensors that can collect minute-to-minute data on heart rate and activity level that may be transmitted to a smartphone or computer. Through this system, users can easily track and monitor their fitness progress.
In this trial, the investigator will seek to determine the feasibility of wearable biometric sensors to acquire high resolution biometric data, including heart rate and activity level (i.e. steps) for patients undergoing radiation therapy and surgery, with or without postoperative radiotherapy. The investigator believe that changes in heart rate may predict for increasing pain, dehydration, and stress in general. Moreover, changes in daily step count are a surrogate for performance status on treatment, and the investigator will perform a series of preliminary analyses to assess whether there is validity to this hypothesis. The investigator hope to use biometric monitoring to identify patients at risk for adverse outcomes, with the ultimate goal of intervening before these outcomes occur.
- Conditions
- Cancer of Head and Neck
- Being tested
- wearable sensor
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wearable sensorDevice
Also called FITBIT
A commercially-available wearable fitness sensor
| Study group | Role | What they receive |
|---|---|---|
| Chemoraditherapy | Experimental | Patients with head and neck cancer require chemo and radiation therapy (Cohort A):
A wearable sensor device will be issued at the time of trial enrollment. Patients will be instructed to wear the device on their wrist for 23 hours per day, 7 days per week, from the time of their radiation simulation through one week following the end of radiation treatment Receives: Device: wearable sensor |
| Primary surgery w/o radiotherapy | Experimental | Patients with head and neck cancer require primary surgery alone (Cohort B-SA)
A wearable sensor device will be issued at the time of trial enrollment. Patients will be instructed to wear the device on their wrist for 23 hours per day, 7 days per week, from one week before surgery through 1 month following surgery
Patients with head and neck cancer require primary surgery and postoperative radiotherapy (Cohort B-RT)
A wearable sensor device will be issued at the time of trial enrollment. Patients will be instructed to wear the device on their wrist for 23 hours per day, 7 days per week, from one week before surgery to one week following the end of radiation treatment . Receives: Device: wearable sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who could wear the device more than 90% of the time, of 23 hours a day, daily
To determine the feasibility of using a commercially-available wearable sensor to obtain biometric data for patients undergoing head and neck locoregional therapy throughout the duration of radiation treatment (cohorts A, B-RT) and throughout post-surgical recovery with or without adjuvant radiotherapy (cohort B)
Measured: 3 months
Daily data acquisition rate
Percentage of successful data acquisition events as well as a retention rate of all enrolled participants.
Measured: 3 months
Secondary outcomes (10)
Changes in daily steps taken
Data will be collected using the Fitbit device and aggregated using the Fitabase platform throughout the duration of radiation treatment (cohorts A, B-RT) and throughout post-surgical recovery with or without adjuvant radiotherapy (cohort B).
Measured: 3 months
Changes in heart rate
Data will be collected using the Fitbit device and aggregated using the Fitabase platform throughout the duration of radiation treatment (cohorts A, B-RT) and throughout post-surgical recovery with or without adjuvant radiotherapy (cohort B).
Measured: 3 months
Changes in sleep habits
Data will be collected using the Fitbit device and aggregated using the Fitabase platform throughout the duration of radiation treatment (cohorts A, B-RT) and throughout post-surgical recovery with or without adjuvant radiotherapy (cohort B).
Measured: 3 months
Volume of intravenous fluids
To analyze associations between biometric parameters and complications and interventions by the volume of intravenous fluids required for patients undergoing radiation treatment (cohorts A, B-RT) and surgical recovery +/-adjuvant radiotherapy (cohort B).
Measured: 3 months
Days of inpatient hospitalization
To analyze associations between biometric parameters and complications and interventions days of inpatient hospitalization required for patients undergoing radiation treatment (cohorts A, B-RT) and surgical recovery +/-adjuvant radiotherapy (cohort B).
Measured: 3 months
Changes in pain level
To analyze associations between biometric parameters and complications and interventions by changes in pain level of patients undergoing radiation treatment (cohorts A, B-RT) and surgical recovery +/-adjuvant radiotherapy (cohort B).
Pain assessments are based on self-report. Pain scale from 0 no pain, 1-3 minor pain, 4-6 moderate pain to 7-10 severe pain.
Measured: 3 months
Number of emergency department visits.
To analyze associations between biometric parameters and complications and interventions number of emergency department visits required for patients undergoing radiation treatment (cohorts A, B-RT) and surgical recovery +/-adjuvant radiotherapy (cohort B).
Measured: 3 months
Utilization of pain medication
To analyze associations between biometric parameters and complications and interventions utilization of pain medication required for patients undergoing radiation treatment (cohorts A, B-RT) and surgical recovery +/-adjuvant radiotherapy (cohort B).
Medication Quantification Scale (MQS) Version III will be used to determine drug detriment weight and dosage level.
Measured: 3 months
Physical and mental well-being
To analyze associations between biometric parameters and patient-reported outcomes in regards to physical and mental well-being using the Functional Assessment of Cancer Therapy - General (FACT-G) Health Survey at each weekly scheduled visit to monitor for acute changes in their condition.
Measured: 3 months
Sleep quality
To analyze associations between biometric parameters and patient-reported outcomes in regards to sleep quality using the Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start30 Oct 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of Head and NeckStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Sher, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574870
- Sponsor's protocol ID
- STU 102016-059
- Acronym
- FITBIT
- Status last verified
- Jan 2021
- First submitted
- 18 May 2018
- Last updated
- 15 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Wearable Sensor for Acquisition of Biometric Data in Head and Neck Cancer Patients During Locoregional Therapy
- ClinicalTrials.gov ID
- NCT03574870
- Acronym / sponsor ID
- FITBIT / STU 102016-059
- Conditions
- Cancer of Head and Neck
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 2 Jul 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.
The investigator will seek to determine the feasibility of wearable biometric sensors to acquire high resolution biometric data, including heart rate and activity level (i.e. steps) for patients undergoing radiation therapy and surgery, with or without postoperative radiotherapy.
Detailed description
Active cancer treatment such as surgery, chemotherapy or radiotherapy can cause side effects or toxicities, which, if untreated, can lead to poorer quality of life, decreased patient well-being, and worse clinical outcomes. Routine monitoring of patients while under active treatment can entail the routine practice of clinic visits at regular intervals with the acquisition of vital signs, routine laboratory testing, patient-reported outcome surveys, and face-to-face interaction with their physician.
In recent years, the availability of commercially-available wearable fitness sensors has allowed end-users to monitor their fitness progress and activity levels. These devices depend on small sensors that can collect minute-to-minute data on heart rate and activity level that may be transmitted to a smartphone or computer. Through this system, users can easily track and monitor their fitness progress.
In this trial, the investigator will seek to determine the feasibility of wearable biometric sensors to acquire high resolution biometric data, including heart rate and activity level (i.e. steps) for patients undergoing radiation therapy and surgery, with or without postoperative radiotherapy. The investigator believe that changes in heart rate may predict for increasing pain, dehydration, and stress in general. Moreover, changes in daily step count are a surrogate for performance status on treatment, and the investigator will perform a series of preliminary analyses to assess whether there is validity to this hypothesis. The investigator hope to use biometric monitoring to identify patients at risk for adverse outcomes, with the ultimate goal of intervening before these outcomes occur.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemoraditherapy | Experimental | Device: wearable sensorPatients with head and neck cancer require chemo and radiation therapy (Cohort A): A wearable sensor device will be issued at the time of trial enrollment. Patients will be instructed to wear the device on their wrist for 23 hours per day, 7 days per week, from the time of their radiation simulation through one week following the end of radiation treatment |
| Primary surgery w/o radiotherapy | Experimental | Device: wearable sensorPatients with head and neck cancer require primary surgery alone (Cohort B-SA) A wearable sensor device will be issued at the time of trial enrollment. Patients will be instructed to wear the device on their wrist for 23 hours per day, 7 days per week, from one week before surgery through 1 month following surgery Patients with head and neck cancer require primary surgery and postoperative radiotherapy (Cohort B-RT) A wearable sensor device will be issued at the time of trial enrollment. Patients will be instructed to wear the device on their wrist for 23 hours per day, 7 days per week, from one week before surgery to one week following the end of radiation treatment . |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Biopsy-proven malignancy requiring chemoradiation therapy to the head and neck, OR primary surgery to the head and neck, with or without adjuvant radiotherapy or chemoradiotherapy.
- Age ≥ 18 years.
- Performance status ECOG 0-2
- Per typical radiotherapy policy, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry.
- 3.1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
Key exclusion criteria (2 listed)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
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 |
|---|---|---|
| wearable sensorAlso: FITBITA commercially-available wearable fitness sensor | Device | Chemoraditherapy, Primary surgery w/o radiotherapy |
Primary outcome
Number of participants who could wear the device more than 90% of the time, of 23 hours a day, daily
Time frame: 3 months
To determine the feasibility of using a commercially-available wearable sensor to obtain biometric data for patients undergoing head and neck locoregional therapy throughout the duration of radiation treatment (cohorts A, B-RT) and throughout post-surgical recovery with or without adjuvant radiotherapy (cohort B)
Daily data acquisition rate
Time frame: 3 months
Percentage of successful data acquisition events as well as a retention rate of all enrolled participants.
10 secondary outcomes
Changes in daily steps taken
Time frame: 3 months
Changes in heart rate
Time frame: 3 months
Changes in sleep habits
Time frame: 3 months
Volume of intravenous fluids
Time frame: 3 months
Days of inpatient hospitalization
Time frame: 3 months
Changes in pain level
Time frame: 3 months
Number of emergency department visits.
Time frame: 3 months
Utilization of pain medication
Time frame: 3 months
Physical and mental well-being
Time frame: 3 months
Sleep quality
Time frame: 3 months
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 15 Jan 2021.
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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.
David Sher, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wearable sensor in people with Cancer of Head and Neck, run by University of Texas Southwestern Medical Center 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 11 inclusion and 2 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 15 Jan 2021. 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?
Number of participants who could wear the device more than 90% of the time, of 23 hours a day, daily (time frame: 3 months). The study lists 2 primary outcomes in all. 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 15 Jan 2021.