Treating Cognitive Impairments in Cancer Patients Via Systematic Light Exposure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Cognitive Functioning (Neuropsychological Tests)
研究概览
简要总结
Cognitive impairment (such as memory problems) due to cancer and its treatment can interfere with quality of life and can linger long after treatment has ended, yet research examining cognitive rehabilitation approaches has produced limited clinical benefit. The proposed study will provide information about systematic light exposure for the treatment of cognitive impairment in hematopoietic stem cell transplant (HSCT) survivors and will investigate how it works. This study would facilitate the development of this potential treatment, giving health care providers and cancer survivors a much-needed tool to help with cancer-related cognitive impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a history of HSCT,
- •1 to 5 years post-HSCT,
- •Relapse-free since most recent HSCT,
- •Age 21 or older,
- •English language proficient
- •Able to provide informed consent
- •Endorse subjective cognitive impairment.
排除标准
- •Diagnosed or suspected neurological, psychiatric (including bipolar disorder or mania), or medical condition that might impair cognitive functioning (other than those caused by the cancer or its treatment),
- •Visual, hearing, or physical impairment sufficient to interfere with cognitive testing or participation,
- •Have a history of whole brain irradiation or surgery,
- •Active diagnosis of autoimmune and/or inflammatory disorder or disorders that may influence immune processes,
- •Chronic use of oral steroid medication,
- •History of systematic light exposure treatment,
- •Diagnosed sleep apnea or narcolepsy,
- •Use of photosensitizing medications,
- •Plan to travel across meridians during the study,
- •Work night, early morning, or swing shifts,
- •Adults unable to consent, individuals who are not yet adults, pregnant women and prisoners will be excluded from the study.
结局指标
主要结局
Cognitive Functioning (Neuropsychological Tests)
时间窗: Baseline to end-of-intervention to 8 weeks after the intervention
Global composite z-score from baseline to 8 weeks after the intervention based on the HVLT-R; BVMT-R; Psychomotor vigilance task; Trail-making tests A and B; WAIS-IV Coding, Digit Span, Block Design; D-KEFS Color-Word Inhibition, Verbal Fluency; Conners Continuous Performance Test III. Raw scores at baseline of tests within single domains were averaged and then standardized to z-scores. The mean of the z-scores was calculated, and then this composite z-score was standardized to z-scores. Follow up intervention z-scores were calculated based on differences between raw scores at baseline and raw scores at follow-up time points and divided by the standard deviation of the baseline domain z-score) within each domain, and then averaged to create follow up global composite scores. A z-score below 0 indicated poorer performance than at baseline and a z-score above 0 indicated better performance than at baseline.
次要结局
- Circadian Activity Rhythms (Actigraphy)(Baseline to end of intervention to 8 weeks later)
- Depressed Mood (CESD)(Baseline, Mid-intervention, End of intervention, 8 weeks later)
- Interleukin-6(Baseline and end-of-intervention)
- Pro-inflammatory Cytokine - TNF Alpha(Baseline and end-of-intervention)
- Fatigue (FACIT-fatigue)(Baseline, mid-intervention, end of the intervention, 8 weeks later)
- Sleep Quality (Pittsburgh Sleep Quality Index)(Baseline, mid intervention, end of intervention, 8 weeks later)
- Quality of Life (FACT-BMT)(Baseline, End of intervention, 8 weeks post-intervention)
- C-Reactive Protein(Baseline and end-of-intervention)
- Neurobehavioral Functioning (Frontal Systems Behavioral Scale)(Baseline, mid-intervention, end-of-intervention, 8 weeks later)
- Self-reported Cognitive Function (Patient Assessment of Own Functioning Inventory)(Baseline, mid-intervention, end of intervention, 8 weeks after intervention)
研究者
Lisa M. Wu
Assistant Professor
Northwestern University