Sleep in Pediatric HSCT

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-18

Study Completion Date

2022-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sleep Stem Cell Transplant Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Aggregated N of 1 design (ABA or AAB)

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

actigraphy scoring will be conducted by study staff blind to patient study arm

Study Groups

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Observation-Intervention-Observation

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

Group Type EXPERIMENTAL

Extended time between vitals check

Intervention Type BEHAVIORAL

Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)

Observation-Observation-Intervention

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

Group Type EXPERIMENTAL

Extended time between vitals check

Intervention Type BEHAVIORAL

Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)

Interventions

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Extended time between vitals check

Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No