Measuring the Feasibility and Effect of a Virtual Reality Cognitive Training Intervention for Brain Cancer Survivors.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility defined as >80% (> 16 participants out of 20) able to complete the experimental arm study in 4 weeks.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •1. History of serious mental or severe psychiatric illnesses (e.g., bi-polar disorder, schizophrenia etc....).
- •a. Note: Anxiety or depression are not exclusionary.
- •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).
- •History of acute traumatic brain injury.
- •History of stroke causing a cognitive deficit only.
- •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.
- •Enrolled in another clinical trial which does not permit co-enrollment.
- •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.
结局指标
主要结局
Feasibility defined as >80% (> 16 participants out of 20) able to complete the experimental arm study in 4 weeks.
时间窗: 4 weeks
FEASIBILITY: Measure the feasibility of using VR-CRT and Control (i.e., paper-based Word-search puzzles (WSP)) with brain cancer survivors (BCS) experiencing cancer-related cognitive impairment (CRCI). Feasibility: will be defined as \>80% (\> 16 participants out of 20) able to complete the experimental arm study in 4 weeks. Since the standard/control arm is well established and routine, feasibility evaluation is not required in this arm. (If subjects withdraw in disproportion in two arms after the randomization, the study may be suspended for further evaluation.)
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.
时间窗: 4 weeks
ACCEPTABILITY: Measure the acceptability of using VR-CRT and Control (i.e., paper-based Word-search puzzles (WSP)) with brain cancer survivors (BCS) experiencing cancer-related cognitive impairment (CRCI). Acceptability: will be 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. (See sections 3.1, 17.1 for detail.) This score of \>8 for all 14 responses will be calculated as an average of all of the completed sub-scales per each subject. Any missing sub-scales (non-response by subjects) will not be considered into the calculation of the mean per subject. The score of \>8 must be observed in \>80% (\>32 participants) to be considered acceptable.
Effect of VR-CRT (and Control) on cognitive function measured by scores at baseline and post-intervention,using 1.) Hopkins Verbal Learning Test
时间窗: 4 weeks
EFFECT: Estimate the effect of VR-CRT (and Control) on brain cancer survivors' cognitive function such as memory, attention/focus, processing speed, and executive function. Effect: will be measured by 1.) Hopkins Verbal Learning Test (HVLT)
Effect of VR-CRT (and Control) on cognitive function measured by scores at baseline and post-intervention,using 2.) Controlled Oral Word Association
时间窗: 4 weeks
EFFECT: Estimate the effect of VR-CRT (and Control) on brain cancer survivors' cognitive function such as memory, attention/focus, processing speed, and executive function. Effect: will be measured by comparing scores collected at baseline and post-intervention, (i.e., at the conclusion of a four-week intervention period) using 2.) Controlled Oral Word Association (COWA)
Effect of VR-CRT (and Control) on cognitive function measured by scores at baseline and post-intervention,using 3.) Trail Making A-B
时间窗: 4 weeks
EFFECT: Estimate the effect of VR-CRT (and Control) on brain cancer survivors' cognitive function such as memory, attention/focus, processing speed, and executive function. Effect: will be measured by comparing scores collected at baseline and post-intervention, (i.e., at the conclusion of a four-week intervention period) using 3.) Trail Making A-B (TMa/b).
次要结局
未报告次要终点
研究者
Anthony Faiola
Principal Investigator
University of Cincinnati