Insomnia Prevention in Children With Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Enrollment Rate of Participants
研究概览
简要总结
The goal of this research study is to understand the acceptability and feasibility of the Sleep ALL Night intervention among children with Acute Lymphoblastic Leukemia (ALL) in hopes of improving the discussion of sleep disorders with clinical providers.
The name of the intervention used in this research study is: Sleep ALL Night, which is a sleep intervention program comprised of an action plan tool and psychoeducational website.
详细描述
This research study is to conduct a single-arm pilot study to determine the acceptability and feasibility of Sleep ALL Night for children with Acute Lymphoblastic Leukemia (ALL).
Participation in this research study is expected to last 1 month.
It is expected about 30 children will take part in this research study.
The National Cancer Institute (NCI) is providing funding for this research study through a grant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient in the Maintenance Phase of therapy on or as per DFCI 16-001 and has completed at least two cycles of maintenance therapy to allow adequate recovery from the more intensive Consolidation phase.
- •English or Spanish speaking child and primary caregiver (parent/guardian).
- •Child aged 4-12 years.
排除标准
- •Primary team declines permission to approach.
- •Children with critical illness (defined as ICU admission)
结局指标
主要结局
Enrollment Rate of Participants
时间窗: At screening, when eligible participants are approached by research staff. Recruitment occurred over a 5-month period.
The primary study outcome of acceptability is defined as the proportion of eligible participants who are approached by research staff who agree to participate in the study, with the cutoff set at ≥30% of eligible participants who are approached agreeing to participate.
Acceptability of Intervention Measure Scale Score
时间窗: At Week 4
The primary study outcome of acceptability is defined as participants reporting an average score of ≥4 ("Agree") on the Acceptability of Intervention Measure scale, a four-item questionnaire assessing the acceptability of an intervention. The scale uses a 5-point scale with options ranging from Completely Agree (5) to Completely Disagree (1). The average score of all four items was used as the primary outcome. A higher score indicates greater belief that the intervention was acceptable for the participant.
Intervention Assessment Completion Rate
时间窗: Up to 1 month after the conclusion of the study period, up to 8 weeks.
The primary study outcome of feasibility is defined as ≥80% of enrolled participants complete the Post-Intervention Assessment.
次要结局
未报告次要终点
研究者
Eric Zhou, PhD
Principal Investigator
Dana-Farber Cancer Institute