Feasibility And Efficacy Of An iPad-Based Cognitive Rehabilitation Program In Brain Tumor Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Change in attention
研究概览
简要总结
This pilot clinical trial studies how well an iPad-based cognitive rehabilitation program works in improving quality of life in patients with grade II-III glioma. An iPad-based cognitive rehabilitation program may help to increase patients cognitive function and quality of life, and may provide doctors with valuable information for optimizing care of patients with brain tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Patients must have histologically confirmed WHO grade 2 or 3 gliomas.
- •Patients must be > 18 years old
- •Patients must have a life expectancy > 12 weeks.
- •Patients must have a Karnofsky performance status of >
- •This study was designed to include women and minorities, but was not designed to measure differences between them. Males and females will be recruited with no preference to gender. Minorities will actively be recruited to participate. No exclusion to this study will be based on race.
- •Patients must speak and be able to read English fluently.
- •All patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must sign an authorization for the release of their protected health information.
- •Patients may not be known to be HIV-positive. HIV testing is not required for study participation.
- •Patients must not have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years.
- •Patients must be receiving MRI scans at UCSF
- •Patients must be clinically stable and off treatment (e.g. radiation or chemotherapy) for ≥ 6 months
- •Patients must be ≥ 6 months from craniotomy
- •Patients must have subjective complaints of cognitive deficits.
- •Patients must have adequate seizure control and be on a stable, or decreasing, dose of anti-epileptics
排除标准
- •Patients who are not able to comply with study and/or follow-up procedures.
- •Patients who do not have home access to the Internet.
- •Patients who, based on the physician's opinion, are unable to participate in neurocognitive testing and/or neurocognitive rehab secondary to significant neurologic deficit
结局指标
主要结局
Change in attention
时间窗: At baseline, 3 months past training start, 9 months past training start
Evaluation of visual attention on the NIH Toolbox Flanker Inhibitory Control and Attention Test. The attention score ranges from 0 to 10 (10 = best performance)
Change in working memory
时间窗: At baseline, 3 months past training start, 9 months past training start
Evaluation of working memory using the NIH Toolbox List Sorting Working Memory Test. Higher scores on each of these indicate higher levels of working memory.
Number of subjects who complete the intervention
时间窗: At 3 months after start of training
Subjects who complete all of the intervention exercises (approximately 36 hours of intervention).
Patient-reported user satisfaction
时间窗: At 3 months after start of training
Questionnaire based measure of user satisfaction as a measure of feasibility.
Patient-reported ease of use
时间窗: At 3 months after start of training
Questionnaire based measure of ease of use as a measure of feasibility.
Change in Quality of Life
时间窗: At baseline, 3 months past training start, 9 months past training start
Measurement of general quality of life (QOL) using Functional Assessment of Cancer Therapy-Brain (FACT-Br), a multi-item questionnaire. Higher ratings suggest higher QOL.
次要结局
- Improvement on neurocognitive testing(At baseline, 3 months past training start, 9 months past training start)
- Subjective assessment of cognitive symptoms will be assessed(At baseline, 3 months past training start, 9 months past training start)