Sleep in Pediatric HSCT

Study Overview
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Brief Summary
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Through an aggregated N=1 randomized controlled design (each patient will serve as their own control, with the 5-day intervention period determined by randomization), the current study will test the acceptability, feasibility, and impact on sleep and supportive care engagement of protecting one 6-hour window for nighttime sleep (intervention) relative to regular vitals checks (observation only periods) during Hematopoietic Stem Cell Transplant (HSCT) recovery.

Detailed Description
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Context: Patients undergoing treatment for cancer face disease, treatment, and environmental obstacles to sufficient, sound sleep. Hospitalizations can further worsen sleep quality and quantity due to overnight vitals checks, medication administration, blood draws, and environmental noise and light. For patients undergoing hematopoietic stem cell transplant (HSCT), the risk for poor sleep is especially high due to protracted hospitalization, frequent vitals checks resulting in multiple night awakenings, and high symptom burden peaking approximately 10 days post-transplant. Objectives: Primary: Test the acceptability and feasibility of protecting one 6-hour window for nighttime sleep (intervention) relative to regular vitals checks (observation only periods) during HSCT recovery. Secondary: Assess the effect of one 6-hour window for nighttime sleep on subject sleep and engagement in supportive care on the oncology unit. Study Design: Aggregated N=1 randomized controlled design. All participants will undergo a 5 day observation and then be randomized to receive the 5 day intervention (extended vitals checks) during either nights of days +5-+9 or days +10-+14. Setting/Participants: Inpatients on the HSCT Unit at the Children's Hospital of Philadelphia (CHOP) Study Interventions and Measures: Intervention-increasing time between vitals checks from every 4 hours to one 6-hour period at night. Subjects will wear an actigraph for the duration of the study, complete a daily sleep diary, and complete self- and parent-proxy psychosocial measures (symptom burden, health related quality of life, sleep) and acceptability. Medical record review will also be conducted to assess vitals check frequency.

Official Title
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Sleep in Pediatric Hematopoietic Stem Cell Transplant Patients

Conditions
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Sleep, Stem Cell Transplant Complications

Intervention / Treatment
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* Behavioral: Extended time between vitals check


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females age 8 to 21 years. Undergoing HSCT at The Children's Hospital of Philadelphia Parent/guardian permission (informed consent) and if appropriate, child assent. Exclusion Criteria: History of developmental delays given the relationship to sleep/wake patterns Sleep disorder diagnosis as documented in the medical record Cognitive delays that impact the ability to complete study measures Not proficient in English

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Aggregated N of 1 design (ABA or AAB)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Observation-Intervention-Observation<br>5 days of observation, 5 days of extended vitals check, 5 days returning to regular vitals checks | Behavioral: Extended time between vitals check<br>* Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)<br>|
| Experimental: Observation-Observation-Intervention<br>5 days of observation, 5 more days of observation, 5 days of extended vitals check | Behavioral: Extended time between vitals check<br>* Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient acceptability questionnaire | Brief questionnaire evaluating the patient's acceptability of adjusting vitals checks. | 15 days after transplant | 
| Parent acceptability questionnaire | Brief questionnaire evaluating the parent's acceptability of adjusting vitals checks. | 15 days after transplant | 
| Nurse acceptability questionnaire | Brief questionnaire evaluating the nurse's acceptability of adjusting vitals checks. | 15 days after transplant | 
| Health-related quality of life (HRQL) | Using the Pediatric Quality of Life Inventory - Stem Cell Transplant (SCT) module | Baseline visit (1-2 days before transplant), 5 days after transplant, 10 days after transplant, and 15 days after transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Actigraphy sleep efficiency | Sleep efficiency is the percentage of time spent asleep, while in bed. It is calculated by dividing the time spent asleep, by the total amount of time in bed. | Day of the transplant through 15 days after the transplant | 
| Actigraphy total sleep time | This will measure the total amount of time the subject sleeps. | Day of the transplant through 15 days after the transplant | 
| Actigraphy number of awakenings | This measure the number of times the subject awakens from rest, whether sleep or a nap. | Day of the transplant through 15 days after the transplant |