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临床试验/NCT06468618
NCT06468618招募中不适用

Developing Restful Environments and Management Strategies for Pediatric Stem Cell Transplant Patients

Dana-Farber Cancer Institute4 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年8月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
4
主要终点
Acceptability of Intervention Measure Scale Score

研究概览

简要总结

Pediatric patients undergoing stem cell transplant (SCT) are hospitalized for extended periods and are at high risk for sleep disturbances. In order to begin to address the environmental issues that SCT recipients face during inpatient hospitalizations, investigators will conduct a single arm pilot study of a program entitled 'Developing Restful Environments and Management Strategies' (DREAMS). The program will provide children receiving SCT and families with information and a kit that includes tools which may support sleep and circadian health during an inpatient hospitalization.

详细描述

In prior work, investigators conducted a study in which sound and light levels were recorded at one-minute intervals within an inpatient room on the SCT unit at Boston Children's Hospital using noise and light meters. Results showed that pediatric SCT recipients were consistently exposed to disruptive noise and light. Nighttime noise levels always exceeded World Health Organization recommendations for sleep, with recipients regularly exposed to multiple noise spikes associated with night wakings. While light levels were frequently dim enough to be conducive to sleep at night, participants were rarely exposed to light bright enough to preserve a healthy circadian rhythm during the day, which has the potential to dysregulate sleep at night. As a child's circadian rhythms may be affected by evening light to a greater extent than adults, such light spikes may be particularly disruptive to circadian rhythms in pediatric participants. The relatively low and afternoon-skewed daytime light, combined with the brighter than recommended light during the evening and early night, has been associated with longer hospitalizations and higher morbidity among adults.

This is a single-arm pilot study to evaluate the acceptability and feasibility of the DREAMS intervention program in stem cell transplant pediatric participants to help support families during this critical phase in a participant's SCT recovery. The data collected from this study will help understand the practicality of delivering the program to a greater number of participants and conducting clinical research about the program in the setting in which it will be implemented.

The research study procedures include screening for eligibility and surveys.

Participation in this research study is expected to last for about 2 weeks.

It is expected that about 10 children will take part in this research study.

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
9 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patient aged 9-17 years.
  • Patient scheduled to receive a stem cell transplant at Boston Children's Hospital.
  • English speaking child and primary caregiver (parent/guardian).

排除标准

  • Primary team declines permission to approach.

研究组 & 干预措施

DREAMS Program

Experimental

Enrolled participants and parent(s) will complete:

  • Baseline visit with survey
  • Standard of care stem cell infusion
  • In-clinic visit with introduction to DREAMS program, Sleep and Circadian Care Kit, Actigraph, and Fitbit.
  • Follow up survey

干预措施: DREAMS Program Video and Care Kit (Behavioral)

结局指标

主要结局

Acceptability of Intervention Measure Scale Score

时间窗: At Follow-up Assessment Visit (Day 21, up to Day 28)

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, on a 5-point scale with options ranging from Completely Agree to Completely Disagree.

Enrollment Rate

时间窗: Screening (Day -30 to -1)

Defined as the proportion of eligible participants approached by research staff and consent to participate in the study with the cutoff set at ≥30% of eligible participants that are approached and agree to participate.

DREAMS Care Kit Usage Rate

时间窗: At Follow-up Assessment Visit (Day 21, up to Day 28)

Feasibility of the DREAMS Program intervention is defined as ≥50% of participants reporting usage of at least one of the Care Kit materials.

Intervention Assessment Completion Rate

时间窗: At Follow-up Assessment Visit (Day 21, up to Day 28)

Feasibility of the DREAMS Program intervention is defined as ≥80% of enrolled participants completing the Follow-up Assessment.

次要结局

  • Program Experience(At Follow-up Assessment Visit (Day 21, up to Day 28))
  • Sleep Diary(Daily, for 1 week, during the study period.)
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Questionnaire(Baseline and Follow-up Assessment Visit (Day 21, up to Day 28))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eric Zhou, PhD

Principal Investigator

Dana-Farber Cancer Institute

研究点 (4)

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