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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
50
Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 15 days after transplant
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.
Time frame: 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.
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Time frame: 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.
Time frame: Day of the transplant through 15 days after the transplant