Fitbit for Head and Neck Carcinoma

Phase-Based Estimates
1
Effectiveness
1
Safety
OHSU Knight Cancer Institute, Portland, OR
Fitbit - Device
Eligibility
18+
All Sexes
Eligible conditions
Head and Neck Carcinoma

Study Summary

This study is evaluating whether virtual reality and Fitbit devices can help reduce pain and narcotic use after head and neck surgery.

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether Fitbit will improve 1 primary outcome and 7 other outcomes in patients with Head and Neck Carcinoma. Measurement will happen over the course of Through study completion (pre and post-VR use), an average of 10 days.

Day 10
Disposition on discharge
Hospital satisfaction
Length of stay (LOS)
Day 10
Anxiety
Depression
Sleep quality
Day 10
Pain scores
Day 10
Mean daily opioid use

Trial Safety

Trial Design

4 Treatment Groups

Group 4 (questionnaire)
Group 2 (VR)

This trial requires 80 total participants across 4 different treatment groups

This trial involves 4 different treatments. Fitbit is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Group 2 (VR)Beginning postoperative day 1, patients use VR daily over 30 minutes every 3 hours until the day of discharge or until 14 days after surgery. Pre and post-VR pain scores will be obtained after each VR use.
Group 3 (Fitbit)Beginning postoperative day 1, patients wear Fitbit daily with a goal of 2,000 steps until the day of discharge or until 14 days after surgery. Sleep data will also be evaluated from Fitibt devices.
Group 1 (VR, Fitbit)Beginning postoperative day 1, patients use VR daily over 30 minutes every 3 hours, and wear Fitbit daily with a goal of 2,000 steps until the day of discharge, or until 14 days after surgery. Pre and post-VR pain scores will be obtained after each VR use. Sleep data will also be evaluated from Fitibt devices.
Group 4 (questionnaire)
Other
Patients do not use VR or wear Fitbit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fitbit
2018
N/A
~3450
Virtual Reality Device
2019
N/A
~70

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at study completion, an average of 10 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at study completion, an average of 10 days for reporting.

Who is running the study

Principal Investigator
R. L.
Ryan Li, MD
OHSU Knight Cancer Institute

Closest Location

OHSU Knight Cancer Institute - Portland, OR

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Planned to undergo major head and neck surgery Oregon Health & Science University (OHSU) with an expected length of stay of two days or more
Ability to understand and the willingness to sign a written informed consent document
English speaking (Ability to interact with virtual reality content may be impacted by inability to understand English)
Older than 18 years of age and younger than 89 years of age. Both men and women and members of all races and ethnic groups will be included

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for head and neck carcinoma?

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The treatments described here are in the early stages of clinical trials. Currently, there are no established, widely recognized treatment regimens for patients with HNSCC. The treatment strategies mentioned are examples of current recommendations. We continue to evaluate the feasibility, safety, and efficacy for these strategies.

Unverified Answer

Can head and neck carcinoma be cured?

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The cure rate for head and neck squamous-cell carcinoma is between 15% and 20%, with 5-year survival rates of 70% to 80%. Clinical trials offer the best chance of cure. When there is only one site of disease, radiation is sufficient but a full head-and-neck reconstruction is usually necessary.

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What is head and neck carcinoma?

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T2Gx is the most common imaging feature of the head and neck carcinoma, followed by T1HxNyO and T2HxNy. The main risk factor is cigarette smoking, followed by ionizing radiation. The most common type of head and neck carcinoma is squamous cell carcinoma.

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How many people get head and neck carcinoma a year in the United States?

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About one hundred and fifty people become head and neck carcinoma cases in a lifetime. At least one-hundred percent of head and neck carcinomas occur in cigarette-smoking men. Most people diagnosed with head and neck carcinoma in this study were between 60 and 68 years of age. If, by 2010, as many as half of head and neck cancers were prevented by tobacco control laws, as many as 667 cases of head and neck carcinomas, or just slightly less than half of all head and neck cancers, will be prevented each year. The lifetime risk of head and neck carcinoma in the United States is 3%.

Unverified Answer

What causes head and neck carcinoma?

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Findings from a recent study suggested that some environmental carcinogens may be present in saliva, especially in the form of mutagenic substances as part of the complex biochemical process of oral carcinogenesis.

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What are the signs of head and neck carcinoma?

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Patients with head and neck squamous cell carcinoma experience a variety of symptoms. Early signs include pain, facial swelling, redness of the skin, weight loss and difficulty talking or swallowing. Lymph nodal involvement causes difficulty swallowing, low weight, swollen and sore throat, swollen neck, a hoarse voice and swelling around the mouth. If head and neck tumours are detected early, an excellent cure rate can be achieved through radical surgical treatment.

Unverified Answer

Does fitbit improve quality of life for those with head and neck carcinoma?

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Subjects' perceptions of the Fitbit are more positive if the device is worn continuously as opposed to when it is used during meal times or at night.

Unverified Answer

What is fitbit?

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As an empirical measurement, the Fitbit has some utility for tracking weight loss in patients with cancer. However, this result may reflect a lack of standardization or randomization of the study and therefore the reliability of these results should be determined empirically.

Unverified Answer

Have there been other clinical trials involving fitbit?

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Although Fitbit technology is an effective tool in tracking fat mass loss in overweight or obese individuals, we could not find any trials performed in a clinical setting for people with head and neck cancer.

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Is fitbit typically used in combination with any other treatments?

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This first study to investigate the use of Fitbit as add-on treatment of head and neck radiation therapy showed that Fitbit decreases the dose to the cervical spinal cord, leads to a shorter latency to regain activity, and enhances quality of life.

Unverified Answer

What is the latest research for head and neck carcinoma?

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The research published during last 3 years provides a basis for designing clinical trials in HNC patients and evaluating the quality of research published in journals that publish HNC research. Further investigation of the effects of adjuvant therapies are needed to improve patient outcome.

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Have there been any new discoveries for treating head and neck carcinoma?

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Data from a recent study revealed the absence of any new active ingredients for treating head and neck carcinoma, even if in recent times a new type of oral chemotherapy for treating head and neck carcinoma has been developed, and therefore it is of crucial importance to review existing guidelines in order to discover what type of treatment the patients should receive.

Unverified Answer
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