NCT07740616

Brief 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. 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
36mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

September 3, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

July 26, 2026

Last Update Submit

July 29, 2026

Conditions

Keywords

Speed of Processing Training

Outcome Measures

Primary Outcomes (1)

  • 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.

    change from baseline in speed of processing at 10 weeks

Study Arms (2)

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.

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.

Other: Home-Based Sham Training

Interventions

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.

Speed of Processing Training

The sham condition includes five interactive video game activities that are self-paced, non-adaptive, and not designed to affect processing speed.

Home-Based Sham Training

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Hon Yuen

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrian Smith

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 26, 2026

First Posted

July 31, 2026

Study Start (Estimated)

September 3, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2029

Last Updated

July 31, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Adhering to laws like HIPAA or GDPR, which strictly prohibit the unauthorize distribution of personally identifiable information

Locations