Sleep in Pediatric HSCT

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Stem Cell Transplant Complications; Sleep

Treatments: Behavioral: Extended time between vitals check

Study type: Interventional

Funder types: Other

Identifiers

NCT04106089

DCHS20PPR006 (Other Grant/Funding Number)

18-015878

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 8 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Observation-Intervention-Observation

Experimental group

Description:

5 days of observation, 5 days of extended vitals check, 5 days returning to regular vitals checks

Treatment:

Behavioral: Extended time between vitals check

Observation-Observation-Intervention

Experimental group

Description:

5 days of observation, 5 more days of observation, 5 days of extended vitals check

Treatment:

Behavioral: Extended time between vitals check