Sleep in Pediatric HSCT

NCT04106089 | Completed Results

• 2 other identifiers: 18-015878DCHS20PPR006
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Stem Cell Transplant Complications

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  15 days after transplant

Secondary Outcomes (3)

• 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

Study Arms (2)

Observation-Intervention-Observation

EXPERIMENTAL

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

Behavioral: Extended time between vitals check

Observation-Observation-Intervention

EXPERIMENTAL

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

Behavioral: Extended time between vitals check

Interventions

Extended time between vitals check BEHAVIORAL

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

Observation-Intervention-Observation; Observation-Observation-Intervention

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Rutgers University: collaborator
• NJ Dept of Health Commission on Cancer Research: collaborator

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 38197636 RESULT

Results Point of Contact

• Title: Dr. Lauren Daniel
• Organization: Rutgers University Camden

lauren.daniel@rutgers.edu

856-225-6535

Study Officials

• Lamia Barakat, PhD

  CHOP

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: actigraphy scoring will be conducted by study staff blind to patient study arm
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Aggregated N of 1 design (ABA or AAB)

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 26, 2019
• Study Start: November 18, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 18, 2024
• Results First Posted: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)