Sleep in Pediatric Hematopoietic Stem Cell Transplant Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Patient Acceptability Questionnaire
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
actigraphy scoring will be conducted by study staff blind to patient study arm
Eligibility Criteria
- Ages
- 8 Years to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Patient Acceptability Questionnaire
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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 Outcomes
- Actigraphy Sleep Efficiency(Day of the transplant through 15 days after the transplant)
- Actigraphy Total Sleep Time(Day of the transplant through 15 days after the transplant)
- Actigraphy Awakenings-minutes Per Day(Day of the transplant through 15 days after the transplant)