Sleep in Pediatric HSCT

Sleep in Pediatric Hematopoietic Stem Cell Transplant Patients

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.

Study Overview

• Status: Completed
• Conditions: Sleep; Stem Cell Transplant Complications
• Intervention / Treatment: Behavioral: Extended time between vitals check

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Males or females age 8 to 21 years.
2. Undergoing HSCT at The Children's Hospital of Philadelphia
3. Parent/guardian permission (informed consent) and if appropriate, child assent.

Exclusion Criteria:

1. History of developmental delays given the relationship to sleep/wake patterns
2. Sleep disorder diagnosis as documented in the medical record
3. Cognitive delays that impact the ability to complete study measures
4. Not proficient in English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Acceptability Questionnaire	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.	15 days after transplant
Parent Acceptability Questionnaire	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.	15 days after transplant
Nurse Acceptability Questionnaire	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.	15 days after transplant
Health-related Quality of Life (HRQL)	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.	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 each day in minutes.	Day of the transplant through 15 days after the transplant
Actigraphy Awakenings-minutes Per Day	This measure the number of minutes per day the subject awakens from rest during nighttime sleep per day.	Day of the transplant through 15 days after the transplant

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: Rutgers University; NJ Dept of Health Commission on Cancer Research
• Investigators: Principal Investigator: Lamia Barakat, PhD, CHOP

Publications and helpful links

General Publications

• Daniel LC, Venella KL, Woodard K, Poliakova P, Gross JY, Bercovitz IN, Moore D, Barakat LP, Freedman JL. Can extending time between vital sign checks improve sleep in hematopoietic stem cell transplant patients? Testing feasibility, acceptability, and preliminary efficacy. Pediatr Blood Cancer. 2024 Apr;71(4):e30832. doi: 10.1002/pbc.30832. Epub 2024 Jan 10.

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2019
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: September 25, 2019
• First Submitted That Met QC Criteria: September 25, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 17, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 18-015878; DCHS20PPR006 (Other Grant/Funding Number: NJ Dept of Health Commission on Cancer Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No