Head and Neck CarcinomaNCT04814524
A Digital Intervention Protocol to Enhance Recovery After Head and Neck Surgery
A study testing Fitbit, Questionnaire Administration and Virtual Reality Device in people with Head and Neck Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
This trial studies examines the impact of virtual reality (VR) experiences and Fitbit wearable activity devices on postoperative recovery after head and neck surgery. Virtual reality has shown to help rehabilitation and pain control primarily in non-surgical fields, and researchers are interested in using this to help… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Head and Neck Carcinoma
- What is being tested?
- Fitbit, Questionnaire Administration and Virtual Reality Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 6 Oct 2022
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Planned to undergo major surgery at Oregon Health \& Science University (OHSU) with the Department of Otolaryngology-Head and Neck Surgery with an expected length of stay (LOS) of 2 days or more
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Planned postoperative admission to the intensive care unit (ICU)
- Social or psychiatric conditions that may interfere with compliance
- Isolation precautions
- Complex head and neck procedure requiring resection or reconstruction involving the scalp, orbit, or mid-face. This would limit the ability to utilize the VR headset
- Reconstruction, incisions, wounds, wound care, or injury that impact the ability to place on the VR headset or wear a Fitbit device around the wrist. This would limit the ability to utilize the VR headset or the Fitbit device
- History of seizure or epilepsy
Show all 15Show fewer
- History of vertigo or persistent dizziness
- Use of cardiac pacemaker, requirement for hearing aid on at all times, or have defibrillators
- Limitations that impair mobility. This would limit the ability to utilize the Fitbit device
- Use of a walker or wheelchair at baseline. This would limit the ability to utilize the Fitbit device
- Children
- Pregnant women
- Neonates of uncertain viability or nonviable neonates
- Decisionally impaired adults
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
This trial studies examines the impact of virtual reality (VR) experiences and Fitbit wearable activity devices on postoperative recovery after head and neck surgery. Virtual reality has shown to help rehabilitation and pain control primarily in non-surgical fields, and researchers are interested in using this to help postoperative pain control. Early mobilization after surgery is also important, and may increase lung capacity, improve gastrointestinal function, reduce pain, and reduce risk of deep venous thrombosis. Use of virtual reality and Fitbit devices may improve postoperative pain control and reduce narcotic use among hospitalized patients after head and neck surgery.
Read the detailed description
PRIMARY OBJECTIVES:
- Evaluate the effectiveness of daily virtual reality (VR) therapy during hospitalization, compared to patients not utilizing daily VR therapy.
II. Evaluate the effectiveness of daily ambulation goals using Fitbit devices during hospitalization, compared to patients without daily ambulation goals.
III. Evaluate the effectiveness of daily VR use and daily Fitbit ambulation goals during hospitalization.
EXPLORATORY OBJECTIVES:
- Evaluate the effectiveness of daily VR use and daily Fitbit ambulation goals during hospitalization on reducing pain scores, anxiety, depression, and length of stay, and improving sleep quality, hospital satisfaction, and disposition on discharge.
OUTLINE: Patients are randomized to 1 of 4 groups.
GROUP 1: Beginning postoperative day 1, patients use VR over 30 minutes up to 4 times daily on weekdays and 2 times daily on weekends, 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 for each VR use. Sleep data may also be evaluated from Fitbit devices.
GROUP 2: Beginning postoperative day 1, patients use VR over 30 minutes up to 4 times daily on weekdays and 2 times daily on weekends until the day of discharge or until 14 days after surgery. Pre and post-VR pain scores will be obtained for each VR use.
GROUP 3: 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 may also be evaluated from Fitbit devices.
GROUP 4: Patients do not use VR or wear Fitbit.
- Conditions
- Head and Neck Carcinoma
- Being tested
- Fitbit, Questionnaire Administration, Virtual Reality Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitbitDevice
Wear Fitbit
Questionnaire AdministrationOther
Ancillary studies
Virtual Reality DeviceDevice
Use VR
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (VR, Fitbit) | Experimental | Beginning postoperative day 1, patients use VR over 30 minutes up to 4 times daily on weekdays and 2 times daily on weekends, 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 for each VR use. Sleep data may also be evaluated from Fitbit devices. Receives: Device: Fitbit; Other: Questionnaire Administration; Device: Virtual Reality Device |
| Group 2 (VR) | Experimental | Beginning postoperative day 1, patients use VR over 30 minutes up to 4 times daily on weekdays and 2 times daily on weekends until the day of discharge or until 14 days after surgery. Pre and post-VR pain scores will be obtained for each VR use. Receives: Other: Questionnaire Administration; Device: Virtual Reality Device |
| Group 3 (Fitbit) | Experimental | 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 may also be evaluated from Fitbit devices. Receives: Device: Fitbit; Other: Questionnaire Administration |
| Group 4 (questionnaire) | Active comparator | Patients do not use VR or wear Fitbit. Receives: Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean daily opioid use
Will be assessed using milligram morphine equivalents (MME). Narcotic use may be compared using One-Way Analysis of Variance (ANOVA) and two sample t-test can be used to compare the narcotic use between intervention group and control group (virtual reality [VR]+Fitbit versus [vs.] control, VR vs. control, Fitbit vs. control). Furthermore, a linear regression model including demographic and clinical characteristic variables with a P-value =< 0.1 will be used to determine factors associated with reduced narcotic use.
Measured: Through study completion, an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Jul 2021
- Primary completion6 Oct 2022
- Study completion6 Oct 2022
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.
- More trials run by OHSU Knight Cancer InstituteThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University
- Responsible party
- Principal investigator, Ryan Li, MD, OHSU Knight Cancer Institute
- Investigators
- Ryan J Li, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814524
- Sponsor's protocol ID
- STUDY00021902
- Other IDs
- NCI-2020-11592, STUDY00021902
- Status last verified
- Oct 2022
- First submitted
- 22 Mar 2021
- Last updated
- 13 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Digital Intervention Protocol to Enhance Recovery After Head and Neck Surgery
- ClinicalTrials.gov ID
- NCT04814524
- Acronym / sponsor ID
- STUDY00021902
- Conditions
- Head and Neck Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 6 Oct 2022 (actual)
- Study completion
- 6 Oct 2022 (actual)
- First posted
- 24 Mar 2021 (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 trial studies examines the impact of virtual reality (VR) experiences and Fitbit wearable activity devices on postoperative recovery after head and neck surgery. Virtual reality has shown to help rehabilitation and pain control primarily in non-surgical fields, and researchers are interested in using this to help postoperative pain control. Early mobilization after surgery is also important, and may increase lung capacity, improve gastrointestinal function, reduce pain, and reduce risk of deep venous thrombosis. Use of virtual reality and Fitbit devices may improve postoperative pain control and reduce narcotic use among hospitalized patients after head and neck surgery.
Detailed description
PRIMARY OBJECTIVES:
- Evaluate the effectiveness of daily virtual reality (VR) therapy during hospitalization, compared to patients not utilizing daily VR therapy.
II. Evaluate the effectiveness of daily ambulation goals using Fitbit devices during hospitalization, compared to patients without daily ambulation goals.
III. Evaluate the effectiveness of daily VR use and daily Fitbit ambulation goals during hospitalization.
EXPLORATORY OBJECTIVES:
- Evaluate the effectiveness of daily VR use and daily Fitbit ambulation goals during hospitalization on reducing pain scores, anxiety, depression, and length of stay, and improving sleep quality, hospital satisfaction, and disposition on discharge.
OUTLINE: Patients are randomized to 1 of 4 groups.
GROUP 1: Beginning postoperative day 1, patients use VR over 30 minutes up to 4 times daily on weekdays and 2 times daily on weekends, 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 for each VR use. Sleep data may also be evaluated from Fitbit devices.
GROUP 2: Beginning postoperative day 1, patients use VR over 30 minutes up to 4 times daily on weekdays and 2 times daily on weekends until the day of discharge or until 14 days after surgery. Pre and post-VR pain scores will be obtained for each VR use.
GROUP 3: 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 may also be evaluated from Fitbit devices.
GROUP 4: Patients do not use VR or wear Fitbit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 (VR, Fitbit) | Experimental | Device: Fitbit, Other: Questionnaire Administration, Device: Virtual Reality DeviceBeginning postoperative day 1, patients use VR over 30 minutes up to 4 times daily on weekdays and 2 times daily on weekends, 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 for each VR use. Sleep data may also be evaluated from Fitbit devices. |
| Group 2 (VR) | Experimental | Other: Questionnaire Administration, Device: Virtual Reality DeviceBeginning postoperative day 1, patients use VR over 30 minutes up to 4 times daily on weekdays and 2 times daily on weekends until the day of discharge or until 14 days after surgery. Pre and post-VR pain scores will be obtained for each VR use. |
| Group 3 (Fitbit) | Experimental | Device: Fitbit, Other: Questionnaire AdministrationBeginning 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 may also be evaluated from Fitbit devices. |
| Group 4 (questionnaire) | Active comparator | Other: Questionnaire AdministrationPatients do not use VR or wear Fitbit. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
- Planned to undergo major surgery at Oregon Health \& Science University (OHSU) with the Department of Otolaryngology-Head and Neck Surgery with an expected length of stay (LOS) of 2 days or more
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (15 listed)
- Planned postoperative admission to the intensive care unit (ICU)
- Social or psychiatric conditions that may interfere with compliance
- Isolation precautions
- Complex head and neck procedure requiring resection or reconstruction involving the scalp, orbit, or mid-face. This would limit the ability to utilize the VR headset
- Reconstruction, incisions, wounds, wound care, or injury that impact the ability to place on the VR headset or wear a Fitbit device around the wrist. This would limit the ability to utilize the VR headset or the Fitbit device
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 |
|---|---|---|
| FitbitWear Fitbit | Device | Group 1 (VR, Fitbit), Group 3 (Fitbit) |
| Questionnaire AdministrationAncillary studies | Other | Group 1 (VR, Fitbit), Group 2 (VR), Group 3 (Fitbit), Group 4 (questionnaire) |
| Virtual Reality DeviceUse VR | Device | Group 1 (VR, Fitbit), Group 2 (VR) |
Primary outcome
Mean daily opioid use
Time frame: Through study completion, an average of 10 days
Will be assessed using milligram morphine equivalents (MME). Narcotic use may be compared using One-Way Analysis of Variance (ANOVA) and two sample t-test can be used to compare the narcotic use between intervention group and control group (virtual reality [VR]+Fitbit versus [vs.] control, VR vs. control, Fitbit vs. control). Furthermore, a linear regression model including demographic and clinical characteristic variables with a P-value =< 0.1 will be used to determine factors associated with reduced narcotic use.
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 13 Oct 2022.
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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.
Ryan J Li principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit, Questionnaire Administration and Virtual Reality Device in people with Head and Neck Carcinoma, run by OHSU Knight Cancer Institute 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 4 inclusion and 15 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 13 Oct 2022. 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?
Mean daily opioid use (time frame: Through study completion, an average of 10 days). 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 13 Oct 2022.