Clinical trial NCT04106089: Sleep in Pediatric HSCT
Official title: Sleep in Pediatric Hematopoietic Stem Cell Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Stem Cell Transplant Complications
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Rutgers University
name: NJ Dept of Health Commission on Cancer Research
First posted: 2019-09-26
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Aggregated N of 1 design (ABA or AAB)
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Acceptability Questionnaire
timeFrame: 15 days after transplant
measure: Parent Acceptability Questionnaire
timeFrame: 15 days after transplant
measure: Nurse Acceptability Questionnaire
timeFrame: 15 days after transplant
measure: Health-related Quality of Life (HRQL)
timeFrame: 15 days after transplant
Secondary outcomes:
measure: Actigraphy Sleep Efficiency
timeFrame: Day of the transplant through 15 days after the transplant
measure: Actigraphy Total Sleep Time
timeFrame: Day of the transplant through 15 days after the transplant
measure: Actigraphy Awakenings-minutes Per Day
timeFrame: Day of the transplant through 15 days after the transplant
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: CHOP
name: Lamia Barakat, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.