Speed of Processing Training to Improve Cognitive Functioning and Driving Performance in Head and Neck Cancer Survivors

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Speed of Processing Training
  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.
• Другое Home-Based Sham Training
  The sham condition includes five interactive video game activities that are self-paced, non-adaptive, and not designed to affect processing speed.

Первичные конечные точки

• Useful Field of View [Срок оценки: change from baseline in speed of processing at 10 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• University of Alabama at Birmingham — Birmingham

Идентификаторы

NCT: NCT07740616 · IRB-300017007 · UAB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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