Speed of Processing Training to Improve Cognitive Functioning and Driving Performance in Head and Neck Cancer Survivors
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Hon Yuen
- Telefoonnummer: 12059346301
- E-mail: yuen@uab.edu
Studie Contact Back-up
- Naam: Adrian Smith
- Telefoonnummer: 2059348931
- E-mail: adrian02@uab.edu
Studie Locaties
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Alabama
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Birmingham, Alabama, Verenigde Staten, 35294
- University of Alabama at Birmingham
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Contact:
- Yuen
- Telefoonnummer: 2059345266
- E-mail: honkeungyuen@gmail.com
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
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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.
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Sham-vergelijker: 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.
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The sham condition includes five interactive video game activities that are self-paced, non-adaptive, and not designed to affect processing speed.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Useful Field of View
Tijdsspanne: change from baseline in speed of processing at 10 weeks
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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.
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change from baseline in speed of processing at 10 weeks
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Hon Yuen, University of Alabama at Birmingham
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB-300017007
- UAB (Andere identificatie: UAB)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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