Developing Restful Environments and Management Strategies for Pediatric Stem Cell Transplant Patients
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: DREAMS Program Video and Care Kit.
- Кому может быть актуально
- Состояния в реестре: Stem Cell Transplant Complications, Sleep Disturbance. Базовые параметры: 9 лет — 17 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Обзор
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.
Подробное описание
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.
The American Cancer Society is supporting this research study with grant funding.
Вмешательства
- Поведенческое DREAMS Program Video and Care Kit
A pediatric, circadian health program comprised of an introductory video to sleep experiences for stem cell transplant recipients, strategies to improve sleep, and a Sleep and Circadian Care Kit which includes ear plugs, a white noise machine, an eye mask, a lightbox, and kit instructions. Actigraph, Fitbit, and tablet will be provided to participant and family.
Первичные конечные точки
- Enrollment Rate [Срок оценки: Screening (Day -30 to -1)]
- Acceptability of Intervention Measure Scale Score [Срок оценки: At Follow-up Assessment Visit (Day 21, up to Day 28)]
- DREAMS Care Kit Usage Rate [Срок оценки: At Follow-up Assessment Visit (Day 21, up to Day 28)]
- Intervention Assessment Completion Rate [Срок оценки: At Follow-up Assessment Visit (Day 21, up to Day 28)]
Вторичные конечные точки (4)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Questionnaire [Срок оценки: Baseline and Follow-up Assessment Visit (Day 21, up to Day 28)]
- Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Questionnaire [Срок оценки: Baseline and Follow-up Assessment Visit (Day 21, up to Day 28)]
- Sleep Diary [Срок оценки: Daily, for 1 week, during the study period.]
- Program Experience [Срок оценки: At Follow-up Assessment Visit (Day 21, up to Day 28)]
Критерии участия
Критерии включения
- 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).
Критерии исключения
-Primary team declines permission to approach.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 2 центра
- Boston Children's Hospital — Boston
- Dana-Farber Cancer Institute — Boston
Публикации
- Fidler AL, Waitt J, Lehmann LE, Solet JM, Duffy JF, Gonzalez BD, Beebe DW, Fedele DA, Zhou ES. Sleep and circadian disruptors: Unhealthy noise and light levels for hospitalized pediatric patients. J Hosp Med. 2023 Nov;18(11):999-1003. doi: 10.1002/jhm.13218. Epub 2023 Oct 2. PMID 37779507
Идентификаторы
NCT: NCT06468618 · 24-254