Sleep in Pediatric HSCT

Sleep Clinical Trial

Official title:

Sleep in Pediatric Hematopoietic Stem Cell Transplant Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04106089
• Other study ID #: 18-015878
• Secondary ID: DCHS20PPR006
• Status: Completed
• Phase: N/A
• Start date: November 18, 2019
• Est. completion date: December 1, 2022

Study information

• Verified date: February 2023
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep
• Stem Cell Transplant Complications

Intervention

Behavioral:
• Extended time between vitals check
Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	NJ Dept of Health Commission on Cancer Research, Rutgers University

Country where clinical trial is conducted

United States, 

References & Publications (30)

Ancoli-Israel S, Moore PJ, Jones V. The relationship between fatigue and sleep in cancer patients: a review. Eur J Cancer Care (Engl). 2001 Dec;10(4):245-55. doi: 10.1046/j.1365-2354.2001.00263.x. — View Citation

Buckhalt JA, El-Sheikh M, Keller P. Children's sleep and cognitive functioning: race and socioeconomic status as moderators of effects. Child Dev. 2007 Jan-Feb;78(1):213-31. doi: 10.1111/j.1467-8624.2007.00993.x. — View Citation

Collins JJ, Byrnes ME, Dunkel IJ, Lapin J, Nadel T, Thaler HT, Polyak T, Rapkin B, Portenoy RK. The measurement of symptoms in children with cancer. J Pain Symptom Manage. 2000 May;19(5):363-77. doi: 10.1016/s0885-3924(00)00127-5. — View Citation

Cushing CC, Walters RW, Hoffman L. Aggregated N-of-1 randomized controlled trials: modern data analytics applied to a clinically valid method of intervention effectiveness. J Pediatr Psychol. 2014 Mar;39(2):138-50. doi: 10.1093/jpepsy/jst083. Epub 2013 Nov 26. — View Citation

Dandoy CE, Coleman KM, Petiniot L, et al. Prospective pilot study evaluating sleep disruption in children and young adults undergoing stem cell transplantation. Biol Blood Marrow Transplant. 2015;21(2):S216.

Ekti Genc R, Conk Z. Impact of effective nursing interventions to the fatigue syndrome in children who receive chemotherapy. Cancer Nurs. 2008 Jul-Aug;31(4):312-7. doi: 10.1097/01.NCC.0000305740.18711.c6. — View Citation

Everson CA. Sustained sleep deprivation impairs host defense. Am J Physiol. 1993 Nov;265(5 Pt 2):R1148-54. doi: 10.1152/ajpregu.1993.265.5.R1148. — View Citation

Felder-Puig R, di Gallo A, Waldenmair M, Norden P, Winter A, Gadner H, Topf R. Health-related quality of life of pediatric patients receiving allogeneic stem cell or bone marrow transplantation: results of a longitudinal, multi-center study. Bone Marrow Transplant. 2006 Jul;38(2):119-26. doi: 10.1038/sj.bmt.1705417. — View Citation

Forrest CB, Meltzer LJ, Marcus CL, de la Motte A, Kratchman A, Buysse DJ, Pilkonis PA, Becker BD, Bevans KB. Development and validation of the PROMIS Pediatric Sleep Disturbance and Sleep-Related Impairment item banks. Sleep. 2018 Jun 1;41(6). doi: 10.1093/sleep/zsy054. — View Citation

Gotte M, Kesting S, Winter C, Rosenbaum D, Boos J. Experience of barriers and motivations for physical activities and exercise during treatment of pediatric patients with cancer. Pediatr Blood Cancer. 2014 Sep;61(9):1632-7. doi: 10.1002/pbc.25071. Epub 2014 Apr 17. — View Citation

Hart CN, Palermo TM, Rosen CL. Health-related quality of life among children presenting to a pediatric sleep disorders clinic. Behav Sleep Med. 2005;3(1):4-17. doi: 10.1207/s15402010bsm0301_3. — View Citation

Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247. — View Citation

Hinds PS, Hockenberry M, Rai SN, Zhang L, Razzouk BI, McCarthy K, Cremer L, Rodriguez-Galindo C. Nocturnal awakenings, sleep environment interruptions, and fatigue in hospitalized children with cancer. Oncol Nurs Forum. 2007 Mar;34(2):393-402. doi: 10.1188/07.ONF.393-402. — View Citation

Hockenberry MJ, Hooke MC, Gregurich M, McCarthy K, Sambuco G, Krull K. Symptom clusters in children and adolescents receiving cisplatin, doxorubicin, or ifosfamide. Oncol Nurs Forum. 2010 Jan;37(1):E16-27. doi: 10.1188/10.ONF.E16-E27. — View Citation

Hui L, Hua F, Diandong H, Hong Y. Effects of sleep and sleep deprivation on immunoglobulins and complement in humans. Brain Behav Immun. 2007 Mar;21(3):308-10. doi: 10.1016/j.bbi.2006.09.005. Epub 2006 Oct 27. Erratum In: Brain Behav Immun. 2010 May;24(4):678-9. — View Citation

Lavigne JV, Arend R, Rosenbaum D, Smith A, Weissbluth M, Binns HJ, Christoffel KK. Sleep and behavior problems among preschoolers. J Dev Behav Pediatr. 1999 Jun;20(3):164-9. doi: 10.1097/00004703-199906000-00005. — View Citation

Lawitschka A, Guclu ED, Varni JW, Putz M, Wolff D, Pavletic S, Greinix H, Peters C, Felder-Puig R. Health-related quality of life in pediatric patients after allogeneic SCT: development of the PedsQL Stem Cell Transplant module and results of a pilot study. Bone Marrow Transplant. 2014 Aug;49(8):1093-7. doi: 10.1038/bmt.2014.96. Epub 2014 May 12. — View Citation

Lee S, Narendran G, Tomfohr-Madsen L, Schulte F. A systematic review of sleep in hospitalized pediatric cancer patients. Psychooncology. 2017 Aug;26(8):1059-1069. doi: 10.1002/pon.4149. Epub 2016 May 5. — View Citation

Lewin DS, Dahl RE. Importance of sleep in the management of pediatric pain. J Dev Behav Pediatr. 1999 Aug;20(4):244-52. doi: 10.1097/00004703-199908000-00007. — View Citation

Mandrell BN, Pritchard M, Browne E, Clifton S, Crabtree VM. A pilot study to examine sleep in pediatric brain tumor patients hospitalized for high dose chemotherapy. Associated Professional Sleep Socities; 2013; Baltimore, MD.

Meltzer LJ, Mindell JA. Relationship between child sleep disturbances and maternal sleep, mood, and parenting stress: a pilot study. J Fam Psychol. 2007 Mar;21(1):67-73. doi: 10.1037/0893-3200.21.1.67. — View Citation

Moldofsky H. Sleep and pain. Sleep Med Rev. 2001 Oct;5(5):385-396. doi: 10.1053/smrv.2001.0179. — View Citation

Moldofsky H. Sleep and the immune system. Int J Immunopharmacol. 1995 Aug;17(8):649-54. doi: 10.1016/0192-0561(95)00051-3. — View Citation

Phipps S, Dunavant M, Garvie PA, Lensing S, Rai SN. Acute health-related quality of life in children undergoing stem cell transplant: I. Descriptive outcomes. Bone Marrow Transplant. 2002 Mar;29(5):425-34. doi: 10.1038/sj.bmt.1703377. — View Citation

Rentscher K, Broman A, Coe C, et al. Biomarkers associated with risk and recovery in cancer patients after hematopoietic stem cell transplantation. Brain Behav Immun. 2017;66:e41-e42.

Rischer J, Scherwath A, Zander AR, Koch U, Schulz-Kindermann F. Sleep disturbances and emotional distress in the acute course of hematopoietic stem cell transplantation. Bone Marrow Transplant. 2009 Jul;44(2):121-8. doi: 10.1038/bmt.2008.430. Epub 2009 Jan 19. — View Citation

Rosen GM, Shor AC, Geller TJ. Sleep in children with cancer. Curr Opin Pediatr. 2008 Dec;20(6):676-81. doi: 10.1097/mop.0b013e328312c7ad. — View Citation

Singer JD, Willett JB. Applied longitudinal data analysis: Modeling change and event occurrence. Oxford university press; 2003.

Smaldone A, Honig JC, Byrne MW. Sleepless in America: inadequate sleep and relationships to health and well-being of our nation's children. Pediatrics. 2007 Feb;119 Suppl 1:S29-37. doi: 10.1542/peds.2006-2089F. — View Citation

Walter LM, Nixon GM, Davey MJ, Downie PA, Horne RS. Sleep and fatigue in pediatric oncology: A review of the literature. Sleep Med Rev. 2015 Dec;24:71-82. doi: 10.1016/j.smrv.2015.01.001. Epub 2015 Jan 13. — View Citation

* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient acceptability questionnaire	Brief questionnaire evaluating the patient's acceptability of adjusting vitals checks.	15 days after transplant
Primary	Parent acceptability questionnaire	Brief questionnaire evaluating the parent's acceptability of adjusting vitals checks.	15 days after transplant
Primary	Nurse acceptability questionnaire	Brief questionnaire evaluating the nurse's acceptability of adjusting vitals checks.	15 days after transplant
Primary	Health-related quality of life (HRQL)	Using the Pediatric Quality of Life Inventory - Stem Cell Transplant (SCT) module	Baseline visit (1-2 days before transplant), 5 days after transplant, 10 days after transplant, and 15 days after transplant
Secondary	Actigraphy sleep efficiency	Sleep efficiency is the percentage of time spent asleep, while in bed. It is calculated by dividing the time spent asleep, by the total amount of time in bed.	Day of the transplant through 15 days after the transplant
Secondary	Actigraphy total sleep time	This will measure the total amount of time the subject sleeps.	Day of the transplant through 15 days after the transplant
Secondary	Actigraphy number of awakenings	This measure the number of times the subject awakens from rest, whether sleep or a nap.	Day of the transplant through 15 days after the transplant