Measuring the Feasibility and Effect of a Virtual Reality Cognitive Training Intervention for Brain Cancer Survivors.

Обзор

The study is focused on assessing the feasibility and effect of a virtual reality training intervention for improving the survivorship journey of brain cancer survivors, post-treatment. The gaming intervention is intended to reduce cognitive impairment, while increasing well-being, mental health, and quality of life.

Подробное описание

This study is focused on assessing the feasibility, acceptability and effect of a virtual reality training intervention for improving the survivorship journey of brain cancer survivors, post-treatment. The gaming intervention is intended to reduce cognitive impairment, while increasing well-being, mental health, and quality of life. In sum, the potential impact of this research is to realize the capability of virtual reality cognitive rehabilitation training (VR-CRT) by mitigating brain cancer survivors (BCS) cognitive decline, while improving overall quality of life (QOL).

Вмешательства

• Другое Virtual Reality System
  Participants randomized to using VR-CRT will have the game already installed/uploaded in the VR headset and ready for use, with their pre-determined participant number for user login and password assigned.
• Другое Word Search Puzzles
  Participants randomized to the control group will have their WSP packet with pre-selected word puzzles that provide a cognitive stimulus but without an increase in complexity. The instructions provided will state how participants should complete the WSP day-by-day. The dated completed WSPs, along with weekly check-ins by the study CRC will constitute the record for the participant's progress over four weeks. CRCs will notify the PI via email if during the call the participant indicates they have

Первичные конечные точки

• Feasibility defined as >80% (> 16 participants out of 20) able to complete the experimental arm study in 4 weeks. [Срок оценки: 4 weeks]
• Acceptability defined as scores of >8 on each subscale of the Senior Technology Acceptance Model (STAM).54 The STAM (Short Version) measures four attitudes towards technology on a Likert scale of 1-10. [Срок оценки: 4 weeks]
• Effect of VR-CRT (and Control) on cognitive function measured by scores at baseline and post-intervention,using 1.) Hopkins Verbal Learning Test [Срок оценки: 4 weeks]
• Effect of VR-CRT (and Control) on cognitive function measured by scores at baseline and post-intervention,using 2.) Controlled Oral Word Association [Срок оценки: 4 weeks]
• Effect of VR-CRT (and Control) on cognitive function measured by scores at baseline and post-intervention,using 3.) Trail Making A-B [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

• Low grade glioma survivors.
• Have mild cognitive impairment (MCI) per MoCA (defined as any score between 18 and 25).
• Completed all cancer treatment for their low-grade glioma (including chemotherapy, immunotherapy, radiation therapy and surgical procedures) and are now >30 days to 24 months from the date of last treatment.
• Age 18 years or older.
• English speaking.
• Able to provide consent without use of a Legally Authorized Representative
• Available to play the VR game or complete word search puzzles once per day for six days per week for four consecutive weeks in their home (per patient self-report).
• Have a reliable phone number by which they can be reached to make arrangement for testing and for follow-up calls.

Критерии исключения

• 1\. History of serious mental or severe psychiatric illnesses (e.g., bi-polar disorder, schizophrenia etc....).

a. Note: Anxiety or depression are not exclusionary. 2. History or known neurodegenerative diseases such as Alzheimer's disease, vascular dementia or any other form of advanced neurodegenerative or neuro-cognitive diseases.

3\. History of drug intoxication/overdose (addiction history). 4. History of acute traumatic brain injury. 5. History of stroke causing a cognitive deficit only. 6. Vision impairments including legal blindness.

a. Note: patients with corrected vision (e.g., glasses or contacts) or who are color-blind are eligible.

7\. Incarcerated at the time of study enrollment. 8. Enrolled in another clinical trial which does not permit co-enrollment. 9. Any medical condition precluding safe use of VR headset and hand control technology, including patients with medical devices, including cardiac pacemakers, hearing aids/cochlear implants and defibrillators.

10\. History of motion sickness per patient self-report.

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

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of Cincinnati Medical Center — Cincinnati

Идентификаторы

NCT: NCT07313709 · UCCC-BN-25-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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