Intervention Strategies to Improve Cognitive Functioning in Hematologic Cancer Survivors After Hematopoietic Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of HCT patients completing the 2-arm wait-listed randomized trial of cognitive training intervention for a period of 3 months
研究概览
简要总结
A pilot study to evaluate feasibility of enrollment of patients in an intervention to improve neurocognitive function in hematopoietic cell transplantation (HCT) survivors using the cognitive training Lumosity program. In addition, patients' interest in receiving information regarding genetic risk of cognitive impairment post-HCT will be measured.
详细描述
The investigators propose using an "off-the-shelf" product - Lumosity (http://www.lumosity.com/) - an online cognitive training program, to address the cognitive impairment in outpatient HCT survivors. The program offers over 60 tasks in game-like format that cover the main cognitive domains: processing speed, working memory, and executive function. Training will involve a daily session of 5 training tasks for 12 weeks. Each time the patient is logged in for a session, a customized report will be generated by the Lumosity program to capture performance information.
Ideally, targeting the intervention and offering it specifically to those at highest risk (integrating clinical and genetic markers) would ensure efficacy. However, evidence is lacking on whether patients are receptive to communication of individual genetic information and whether provision of such results would lead to enhanced intervention response. To realize the high expectations of personalized medicine, patients' preferences and attitudes need to be thoroughly investigated especially as more information on genetic risk becomes available. The investigators will examine patients' genetic knowledge to determine whether factual knowledge of genetics is essential for understanding genetic risk and for informing treatment decision making in this patient population.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 21 years old at time of allogeneic HCT performed at UAB
- •Outpatient and between 3 and 6 months post HCT
- •English speaking
- •Possess access to an internet-connected home computer
排除标准
- •History of pre-existing neurological disorder or documented major psychiatric disorder; significant auditory, visual, or motor impairments
- •Participated in neuropsychological intervention within the past 6 months
- •History of color blindness
研究组 & 干预措施
Intervention
The arm will begin the Lumosity program at enrollment in the study.
干预措施: Lumosity (Behavioral)
Wait List Control
The arm will begin the Lumosity program 3 months after enrollment in the study.
干预措施: Lumosity (waitlist control) (Behavioral)
结局指标
主要结局
Number of HCT patients completing the 2-arm wait-listed randomized trial of cognitive training intervention for a period of 3 months
时间窗: 12 weeks
Number of participants completing the 12 week intervention
Change in cognitive function between intervention and wait list control arms from baseline to 12 weeks.
时间窗: Baseline to 12 weeks
Change in cognitive function will be measured using cognitive test scores at baseline and 12 weeks
次要结局
- 16-item survey to measure genetic factual knowledge at baseline(Baseline)
- Effect size of associations of key predictors with genetic factual knowledge at baseline(Baseline)
- 5 Likert scale survey questionnaire to measure importance of receiving genetic risk information(baseline)
- 5 Likert scale survey questionnaire to measure impact of receiving genetic risk information on intervention adherence(baseline)
- 5 Likert scale survey questionnaire to measure impact of receiving genetic risk information on intervention uptake(baseline)
研究者
Noha Mohamed Sharafeldin
Prinicipal Investigator
University of Alabama at Birmingham