Sleep in Pediatric HSCT

Not Applicable

Completed

Conditions: Sleep
Stem Cell Transplant Complications

Interventions: Behavioral: Extended time between vitals check

Registration Number: NCT04106089

Lead Sponsor: Children's Hospital of Philadelphia

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Observation-Intervention-Observation	Extended time between vitals check	5 days of observation, 5 days of extended vitals check, 5 days returning to regular vitals checks
Observation-Observation-Intervention	Extended time between vitals check	5 days of observation, 5 more days of observation, 5 days of extended vitals check

Primary Outcome Measures

Name	Time	Method
Patient Acceptability Questionnaire	15 days after transplant	Brief questionnaire created for this study evaluating the patient's acceptability of adjusting vitals checks. Participants reported agreement with each statement on a 5-point likert scale from not at all (1) to extremely (5). Higher values indicate greater agreement.
Parent Acceptability Questionnaire	15 days after transplant	Brief questionnaire created for this study evaluating the patient's acceptability of adjusting vitals checks. Participants reported agreement with each statement on a 5-point likert scale from not at all (1) to extremely (5). Higher values indicate greater agreement.
Nurse Acceptability Questionnaire	15 days after transplant	Brief questionnaire created for this study evaluating the nurse's acceptability of adjusting vitals checks. Nurses reported agreement with each statement on a 5-point likert scale from not at all (1) to extremely (5). Higher values indicate greater agreement.
Health-related Quality of Life (HRQL)	15 days after transplant	Using the Pediatric Quality of Life Inventory - Stem Cell Transplant (SCT) module. Scale values range from 0 to 100, with higher scores indicating better functioning.

Secondary Outcome Measures

Name	Time	Method
Actigraphy Sleep Efficiency	Day of the transplant through 15 days after the transplant	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.
Actigraphy Total Sleep Time	Day of the transplant through 15 days after the transplant	This will measure the total amount of time the subject sleeps each day in minutes.
Actigraphy Awakenings-minutes Per Day	Day of the transplant through 15 days after the transplant	This measure the number of minutes per day the subject awakens from rest during nighttime sleep per day.