Head and Neck Cancer (H&N)NCT07740616
Speed of Processing Training to Improve Cognitive Functioning and Driving Performance in Head and Neck Cancer Survivors
A study testing Speed of Processing Training in people with Head and Neck Cancer (H&N), run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The goal of the study is to understand how well cognitive training improves reaction time in people with head and neck cancer (HNC). Aim 1. Evaluate the preliminary clinical effectiveness of a 10-week home- and video game-based SOPT on cognitive functioning and driving performance in HNC survivors. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Head and Neck Cancer (H&N)
- What is being tested?
- Speed of Processing Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2027to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- confirmed HNC diagnosis
- aged ≥ 18 years of all racial, ethnic, and sex/gender categories
- ≥ 6 months post radiation or chemoradiation
- self-reported CRCI, defined as a score of ≥ 60 in the FACT-Cog Perceived Cognitive Impairment subscale
- thyroid-stimulating hormone levels within normal limits
- visual acuity of at least 20/40 using a Snellen eye chart
Show all 11Show fewer
- functional peripheral vision as indicated by the confrontation field test
- functional hearing sufficient to engage in daily conversation in English for ≥ 15 minutes
- intact lower extremity function (Rapid Pace Walk test ≤ 9 sec)
- stable home internet
- sufficient English proficiency to read and understand informed consent materials
Who cannot join
- significant neurologic or psychiatric comorbidities, including psychotic disorders, bipolar disorders, Alzheimer's disease or related dementias, developmental disorders, seizure disorders, vestibular disorders, prior brain tumor or brain surgery, or poorly controlled metabolic disease
- current use of antipsychotic or mood-stabilizing medications due to potential effects on driving performance
- anticipated life expectancy of < 6 months based on physician prognosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Yuen, 2059345266, honkeungyuen@gmail.com
About this study
The goal of the study is to understand how well cognitive training improves reaction time in people with head and neck cancer (HNC). Aim 1. Evaluate the preliminary clinical effectiveness of a 10-week home- and video game-based SOPT on cognitive functioning and driving performance in HNC survivors. This study will include completing five questionnaires and simulated driving in a simulator at two different times, 10 weeks of participating in 2 sessions per week of video-game cognitive training at home and being interviewed once at the end of the 10-week training.
Read the detailed description
If participants agree to participate in the study by signing the informed consent, participants will be randomly assigned (similar to flipping a coin) to one of the two video game cognitive exercise groups. The only difference between these two groups is the intensity of training on reaction time to video game events.
participants will complete questionnaires (socio-demographic information, four short cognitive assessments) and a driving assessment using a high-fidelity motion-based virtual reality driving simulator in the UAB Driver Simulation Lab at baseline. After completing the baseline cognitive and driving evaluations, participants will receive an electronic tablet loaded with access to the assigned video game program and a workbook with instructions and explanations. A staff member will assist participants in logging in, demonstrate the video game cognitive exercises, and show participants how to play a trial game session.
At home, participants will complete 30-minute video game-based cognitive exercises twice weekly for 10 weeks (20 sessions, totaling 10 hours). The software will automatically record the actual session duration. One week after the baseline appointment, the staff will contact participants to address any technical problems. The staff will then contact participants monthly to monitor progress and answer study-related questions.
After the 10-week video game cognitive exercise program, participants will be invited to the UAB Driver Simulation Lab to complete the four short cognitive assessments and a driving assessment as participants did 10 weeks ago.
- Conditions
- Head and Neck Cancer (H&N)
- Being tested
- Speed of Processing Training, Home-Based Sham Training
- Keywords
- Speed of Processing Training
- 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.
Speed of Processing TrainingOther
The training is the game-based cognitive exercises that involve the speed and accuracy of visual information processing and enhance divided attention between central and peripheral stimuli and among peripheral stimuli when distractors are present.
Home-Based Sham TrainingOther
The sham condition includes five interactive video game activities that are self-paced, non-adaptive, and not designed to affect processing speed.
| Study group | Role | What they receive |
|---|---|---|
| Speed of Processing Training | Experimental | The training is the game-based cognitive exercises that involve the speed and accuracy of visual information processing and enhance divided attention between central and peripheral stimuli and among peripheral stimuli when distractors are present. Receives: Other: Speed of Processing Training |
| Home-Based Sham Training | Sham comparator | The sham condition includes five interactive video game activities that are self-paced, non-adaptive, and not designed to affect processing speed. Receives: Other: Home-Based Sham Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Useful Field of View
Useful Field of View (UFOV) examines visual attention and memory that require rapid recognition and response to simultaneous demands in both the central and peripheral visual fields. The test consists of four increasingly complex subtests. In each subtest, stimulus presentations ranging from 17-500 milliseconds are displayed to determine the speed at which visual information is processed. In each subtest, a double staircase method is used to determine the presentation speed at which participants correctly complete the task 75% of the time. Lower scores (fewer milliseconds to correctly perceive the target) reflect faster SOP.
Measured: change from baseline in speed of processing at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start3 Jan 2027 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Cancer (H&N)Studies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hon K. Yuen, PhD, University of Alabama at Birmingham
- Investigators
- Hon Yuen, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740616
- Sponsor's protocol ID
- IRB-300017007
- Other IDs
- UAB
- Status last verified
- Sep 2026
- First submitted
- 26 Jul 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Adhering to laws like HIPAA or GDPR, which strictly prohibit the unauthorize distribution of personally identifiable information
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speed of Processing Training to Improve Cognitive Functioning and Driving Performance in Head and Neck Cancer Survivors
- ClinicalTrials.gov ID
- NCT07740616
- Acronym / sponsor ID
- IRB-300017007
- Conditions
- Head and Neck Cancer (H&N)
- Keywords
- Speed of Processing Training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 3 Jan 2027 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 31 Jul 2026 (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 goal of the study is to understand how well cognitive training improves reaction time in people with head and neck cancer (HNC). Aim 1. Evaluate the preliminary clinical effectiveness of a 10-week home- and video game-based SOPT on cognitive functioning and driving performance in HNC survivors. This study will include completing five questionnaires and simulated driving in a simulator at two different times, 10 weeks of participating in 2 sessions per week of video-game cognitive training at home and being interviewed once at the end of the 10-week training.
Detailed description
If participants agree to participate in the study by signing the informed consent, participants will be randomly assigned (similar to flipping a coin) to one of the two video game cognitive exercise groups. The only difference between these two groups is the intensity of training on reaction time to video game events.
participants will complete questionnaires (socio-demographic information, four short cognitive assessments) and a driving assessment using a high-fidelity motion-based virtual reality driving simulator in the UAB Driver Simulation Lab at baseline. After completing the baseline cognitive and driving evaluations, participants will receive an electronic tablet loaded with access to the assigned video game program and a workbook with instructions and explanations. A staff member will assist participants in logging in, demonstrate the video game cognitive exercises, and show participants how to play a trial game session.
At home, participants will complete 30-minute video game-based cognitive exercises twice weekly for 10 weeks (20 sessions, totaling 10 hours). The software will automatically record the actual session duration. One week after the baseline appointment, the staff will contact participants to address any technical problems. The staff will then contact participants monthly to monitor progress and answer study-related questions.
After the 10-week video game cognitive exercise program, participants will be invited to the UAB Driver Simulation Lab to complete the four short cognitive assessments and a driving assessment as participants did 10 weeks ago.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Speed of Processing Training | Experimental | Other: Speed of Processing TrainingThe training is the game-based cognitive exercises that involve the speed and accuracy of visual information processing and enhance divided attention between central and peripheral stimuli and among peripheral stimuli when distractors are present. |
| Home-Based Sham Training | Sham comparator | Other: Home-Based Sham TrainingThe sham condition includes five interactive video game activities that are self-paced, non-adaptive, and not designed to affect processing speed. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- confirmed HNC diagnosis
- aged ≥ 18 years of all racial, ethnic, and sex/gender categories
- ≥ 6 months post radiation or chemoradiation
- self-reported CRCI, defined as a score of ≥ 60 in the FACT-Cog Perceived Cognitive Impairment subscale
- thyroid-stimulating hormone levels within normal limits
Key exclusion criteria (3 listed)
- significant neurologic or psychiatric comorbidities, including psychotic disorders, bipolar disorders, Alzheimer's disease or related dementias, developmental disorders, seizure disorders, vestibular disorders, prior brain tumor or brain surgery, or poorly controlled metabolic disease
- current use of antipsychotic or mood-stabilizing medications due to potential effects on driving performance
- anticipated life expectancy of < 6 months based on physician prognosis.
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 |
|---|---|---|
| Speed of Processing TrainingThe training is the game-based cognitive exercises that involve the speed and accuracy of visual information processing and enhance divided attention between central and peripheral stimuli and among peripheral stimuli when distractors are present. | Other | Speed of Processing Training |
| Home-Based Sham TrainingThe sham condition includes five interactive video game activities that are self-paced, non-adaptive, and not designed to affect processing speed. | Other | Home-Based Sham Training |
Primary outcome
Useful Field of View
Time frame: change from baseline in speed of processing at 10 weeks
Useful Field of View (UFOV) examines visual attention and memory that require rapid recognition and response to simultaneous demands in both the central and peripheral visual fields. The test consists of four increasingly complex subtests. In each subtest, stimulus presentations ranging from 17-500 milliseconds are displayed to determine the speed at which visual information is processed. In each subtest, a double staircase method is used to determine the presentation speed at which participants correctly complete the task 75% of the time. Lower scores (fewer milliseconds to correctly perceive the target) reflect faster SOP.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No. Adhering to laws like HIPAA or GDPR, which strictly prohibit the unauthorize distribution of personally identifiable information
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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.
Hon Yuen principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speed of Processing Training in people with Head and Neck Cancer (H&N), run by University of Alabama at Birmingham 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 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: opening soon, as of the sponsor's last update on 2 Oct 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hon Yuen (12059346301, yuen@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Useful Field of View (time frame: change from baseline in speed of processing at 10 weeks). 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 2 Oct 2026.