Neuroplasticity-Based Cognitive Remediation for Chemotherapy Related Cognitive Impairment Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Assess whether nCCR training produces change in subjective cognitive complaints breast cancer survivors with CRCI.
研究概览
简要总结
The investigators propose to apply neuroplasticity-based computerized cognitive remediation (nCCR) to treat chemotherapy-related cognitive impairment (CRCI).
详细描述
Successes in breast cancer treatment are resulting in a growing number of cancer survivors. This has broadened the scope of care from treating the disease alone to improving the quality of life of cancer survivors. Chemotherapy-related cognitive impairment (CRCI), often referred to by patients as 'chemobrain,' is a common and highly distressful side effect of chemotherapy often reported by breast cancer survivors. Managing the symptoms of CRCI should be integrated with routine cancer care as these symptoms diminish quality of life, impair work performance, and make it more difficult for patients to follow treatment regimens. CRCI can persist for months to years following cancer treatment. However, there are currently no established treatments for CRCI.
The most commonly reported CRCI symptoms in breast cancer survivors include problems with executive functions. Executive function is a cognitive domain involved in planning, problem-solving, organization, and time management. In order to improve executive dysfunction and quality of life in breast cancer survivors, we propose to use a new brain training program called neuroplasticity-based computerized cognitive remediation (nCCR). The term 'neuroplasticity' refers to the brain's ability to modify, change, and adapt throughout life and in response to experience. Neuroplacticity can be induced through the use of focused brain training that nCCR offers. Past work demonstrates that this neuroscience-guided brain training benefits other patient populations with similar cognitive problems and has shown preliminary success in cancer survivors in a small pilot study. If successful, this treatment could have significant benefits for large numbers of breast cancer survivors.
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)
盲法说明
Both participants and the primary investigator are blinded to the arm of the study they receive.
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All participants will:
- •between 35 and 80 years of age
- •have been diagnosed with noninvasive or invasive breast cancer
- •have undergone treatment with systemic chemotherapy within the last 1- 8 years
- •endorse persistent CRCI subjective complaints
- •have no active unstable medical condition
- •fluent in and able to read English.
排除标准
- •Participants will be excluded for
- •any active neurologic or untreated/non-remitted psychiatric disease, (e.g. active major depression or another major psychiatric disorder as described in DSM-5)
- •clinically significant cognitive impairment identified on cognitive screening, diagnosis of mild cognitive impairment or dementia
- •history of significant head trauma followed by persistent neurologic deficits
- •history of alcohol or substance abuse or dependence within the past 2 years (DSM-5 criteria)
- •any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol
- •Use of any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening
- •red-green color blindness
- •Use of certain CNS active medications (e.g. antidepressants) will be permitted, provided dosing has been stable for at least 3 months.
结局指标
主要结局
Assess whether nCCR training produces change in subjective cognitive complaints breast cancer survivors with CRCI.
时间窗: 6-weeks
Paired samples t-tests will be used to assess FACT-Cog PCI Scores. We hypothesize that nCCR treatment will improve FACT-Cog scores in breast cancer patients with persistent CRCI over 6 weeks of treatment compared to the education control group. The primary measure used to assess subjective cognitive performance was the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) scale and evaluates memory, concentration, mental acuity, verbal fluency, functional interference, and multitasking ability. At baseline and post-treatment visits, participants rated on a 5-point Likert scale how they assessed various aspects of their cognitive functioning over the last 7 days. Higher scores indicate better ratings of cognitive functioning. Higher scores indicate better ratings of cognitive functioning.
次要结局
- Assess whether 6-weeks of nCCR training produces change in cognitive performance on neuropsychological measures in breast cancer survivors with CRCI.(6-weeks)
研究者
Jennifer Vega
Primary Investigator
University of Massachusetts, Worcester