A Pilot Study of Assessing and Improving Cognition and Real-World Behavior in Pediatric Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 70
- 主要终点
- Proportion of participants who complete study
研究概览
简要总结
This pilot study will evaluate the cognitive and behavioral outcomes of using a novel, adaptive attention training in pediatric cancer survivors.
详细描述
Pediatric cancer survivors (PCS) often experience attentional difficulties that have downstream effects on their quality of life, academic achievement, and future occupational attainment. As such, the primary goal of this project is to examine the outcomes of a novel, mindful attention training in this population and assess the feasibility of recruitment, retention, and adherence. Specifically, PCS will be randomly assigned to one of two adaptive attention training groups ('Engage') and complete tasks on the device for up to 8 weeks. Participants will also complete pre- and post-training assessments of cognition and behavior.
An additional cohort of no-contact participants will be asked to complete the assessments at baseline and end of study only to assess the feasibility and reliability of the assessment measures. This cohort will be enrolled separately and not randomized.
The investigators hypothesize that completion of 'Engage' training for the randomized cohorts will result in enhanced attentional control beyond the active comparator group that extends to other aspects of cognition in PCS.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Forty participants will be randomized to the Engage intervention (30-session) or low-dose (2-session). Individuals in each active arm will be matched on age and gender.
An additional thirty participants will be enrolled separately (not randomized) into the no-contact group.
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 7-17 at the time of enrollment.
- •Able to understand study procedures and to comply with them for the entire length of the study.
- •Ability of individual and legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
- •Normal or corrected-normal vision and hearing.
- •English language fluency (minor participant and parent/guardian).
- •Received radiation therapy to the brain or neck between age 7-
- •Patients not on current cancer-related treatment (except supportive care) or those on other current treatments that would not hinder study participation. Patients currently on cancer-related treatments will be discussed with the study team (co-PI Mueller).
排除标准
- •Contraindication to any study-related procedure or assessment.
- •Motor/perceptual difficulties that prevent computer or tablet use.
- •Current cancer-related treatments that would impact the ability to participate in the study (e.g., current inpatient chemotherapy or intrathecal chemotherapy). Patients on other current treatments will be discussed with the study team (co-PI, Dr. Mueller)
结局指标
主要结局
Proportion of participants who complete study
时间窗: Up to 8 weeks
The proportion of participants who completed the study procedures will be reported by study cohort.
次要结局
- Change in mean performance on a Continuous Performance Task (CPT) over time(Up to 8 weeks)