Wearable Sensor for Biometrics During Locoregional Therapy for Head and Neck Cancer

NCT ID: NCT03574870

Last Updated: 2021-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-30
• Study Completion Date: 2019-12-31

Brief 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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Chemoraditherapy

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

Group Type: EXPERIMENTAL

wearable sensor

Intervention Type: DEVICE

A commercially-available wearable fitness sensor

Primary surgery w/o radiotherapy

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 .

Group Type: EXPERIMENTAL

wearable sensor

Intervention Type: DEVICE

A commercially-available wearable fitness sensor

Interventions

wearable sensor

A commercially-available wearable fitness sensor

Intervention Type: DEVICE

Other Intervention Names

FITBIT

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Age ≥ 18 years.

3. 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
• 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).

4. Concurrent chemotherapy is required for definitive radiotherapy patients

5. Hypofractionated or stereotactic body radiation therapy is not permitted

6. Ability to understand and the willingness to sign a written informed consent

7. Willingness to download the Fitbit App to a personal mobile device

Exclusion Criteria

1. 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.

2. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Sher, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

STU 102016-059

Identifier Type: -

Identifier Source: org_study_id