Computerized Cognitive Retraining in Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Satisfaction, measured by the satisfaction survey
研究概览
简要总结
This randomized clinical trial studies computerized cognitive retraining in improving cognitive function in breast cancer survivors. Cancer-related cognitive deficits, such as thinking and memory issues, are common among breast cancer survivors. The severity of these cognitive deficits is associated with a significant negative impact on daily function and quality of life. A computerized cognitive retraining method may help researchers find ways to improve cognitive function and quality of life in breast cancer survivors.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate the feasibility and acceptability of a 6-week computerized working memory training program in breast cancer survivors who subjectively report cognitive deficits: evaluate feasibility of study procedures (recruitment and screening procedures, number of participants recruited, screened, and retained, attrition rate and reason, weekly phone calls completed with participants); evaluate the acceptability of an adaptive computerized working memory training intervention (burden, adherence to training schedule, performance level achieved, and participant satisfaction with computerized exercises).
SECONDARY OBJECTIVES:
I. To evaluate the difference in the posttest means at T2 (week #7) adjusted for T1 (baselines) in the primary working memory outcomes of visuo-spatial working memory (VSWM), visual working memory (VWM), and executive function (EF) as measured by the neuropsychological tests (Rey Auditory Test, Wechsler Adult Intelligence Scale [WAIS] IV symbol test, WAIS IV coding test, Delis-Kaplan Executive Function System [DKFES] color tests, Trails A and Trails B tests, and WAIS IV Letter and Number sequencing test) and self-report Patient Reported Outcomes Measurement Information System (PROMIS) surveys (Applied Cognition General Concerns Short Form, Applied Cognition Executive Function Short Form, and Functional Assessment of Cancer Therapy [FACT] Cognitive Function) between the intervention group and wait control group.
OUTLINE: Patients are randomized to 1 of 2 arms.
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
- •Breast cancer (stage 0, I, II, III), 18 months to 5 years post oncologic therapies of surgery, chemotherapy, and/or radiation therapy (does not exclude current selective estrogen receptor modulators or aromatase inhibitors)
- •Able to read, write, and speak English
- •Mini Mental State Exam score greater than or equal to 19
- •Have reliable internet and daily access to computer with audio/speakers
- •Agree to travel to the Seattle Cancer Care Alliance (SCCA) or University of Washington (UW) School of Nursing for 2-3 in person assessments over the 12-13 weeks of the study
排除标准
- •History of multiple cancers
- •History of central nervous system (CNS) disease, CNS radiation, intrathecal therapy, or CNS surgery
- •History of traumatic brain injury
- •Neurologic disorders of stroke, encephalitis, dementia, epilepsy, Alzheimer's disease, Parkinson's disease
- •Self-report of learning disabilities
- •Substance addiction
- •Diagnosis of psychiatric disorders of psychosis, schizophrenia, or bipolar disorder
- •Mini mental state exam score less than 19
- •Previous participation in cognitive training program
- •Visual impairments such as uncorrected vision or color blindness
- •Uncorrected hearing impairments
- •Self-report that they are not pregnant or planning to become pregnant in the next four months
- •Anticipate moving from the region in the next 4 months
- •Inability to use a mouse or computer keys to navigate around the computer screen
研究组 & 干预措施
Arm I (computer-assisted cognitive training)
Patients complete a computerized working memory training program (Cogmed) over 35 minutes a day, 5 times a week for 6 weeks.
干预措施: Computer-Assisted Cognitive Training (Other)
Arm I (computer-assisted cognitive training)
Patients complete a computerized working memory training program (Cogmed) over 35 minutes a day, 5 times a week for 6 weeks.
干预措施: Questionnaire Administration (Other)
Arm II (wait-list)
Patients undergo standard follow-up care for 6 weeks. Following standard follow-up care, patients may complete Cogmed as in the Intervention Group in weeks 7-13.
干预措施: Questionnaire Administration (Other)
Arm II (wait-list)
Patients undergo standard follow-up care for 6 weeks. Following standard follow-up care, patients may complete Cogmed as in the Intervention Group in weeks 7-13.
干预措施: Standard Follow-Up Care (Procedure)
结局指标
主要结局
Satisfaction, measured by the satisfaction survey
时间窗: Up to 7 weeks
Satisfaction is measured on a 7-point Likert item questionnaire. The frequencies and the mode will be estimated from the satisfaction survey.
Percentage of participants who are recruited
时间窗: Up to 7 weeks
Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant.
Percentage of participants retained in the study
时间窗: Up to 7 weeks
Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant.
Attrition rate
时间窗: Up to 7 weeks
Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant.
次要结局
- Depression(Baseline to up to 7 weeks)
- Anxiety(Baseline to up to 7 weeks)
- Cognition(Baseline to up to 7 weeks)
- Executive Function(Baseline to up to 7 weeks)
- Verbal Working Memory(Baseline to up to 7 weeks)
- Fatigue(Baseline to up to 7 weeks)
- Visuo Spatial Working Memory(Baseline to up to 7 weeks)