NCT00666614

Brief Summary

The purpose of this pilot study is to determine if patients randomized to a hospital sleep environment intervention would have improved sleep quality and reduced fatigue as compared to the patients not receiving the intervention (standard care).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2008

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

August 19, 2019

Status Verified

January 1, 2012

Enrollment Period

3.5 years

First QC Date

April 23, 2008

Last Update Submit

August 15, 2019

Conditions

SleepFatigue

Keywords

SleepFatigueHigh Dose Chemotherapy

Outcome Measures

Primary Outcomes (1)

  • To assess sleep quality, fatigue and daytime activity during the 4 to 6-day hospitalization as being more positive for patients randomized to the sleep environment intervention months as compared to those randomized to the standard care months

    Within 6 -10 months

Study Arms (2)

Intervention

OTHER

Patients randomized to the sleep environment intervention months will experience a relaxation period before nighttime sleep, white noise as selected by the patient, stimulus control strategies, a window covering to diminish hallway light from entering the room, and a nurse-protected 90-minute uninterrupted sleep period at night.

Other: Sleep Environment Intervention

Standard Care

OTHER

Normal Hospital Environment

Other: Normal Hospital Environment

Interventions

Sleep Environment InterventionOTHER

Patients randomized to the sleep environment intervention months will experience a relaxation period before nighttime sleep, white noise as selected by the patient, stimulus control strategies, a window covering to diminish hallway light from entering the room, and a nurse-protected 90-minute uninterrupted sleep period at night.

Intervention
Normal Hospital EnvironmentOTHER

Normal Hospital Environment

Standard Care

Eligibility Criteria

Age4 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients between the ages of 4 and 21 years who are enrolled on SJMB03 and to be admitted for either Course 2 or Course 3 of high dose chemotherapy and stem cell rescue.
  • English - speaking and able to understand English items on the study instruments as these are only available in English.
  • Patients willing to give assent to participate in the study and whose parents are willing to give permission according to institutional guidelines for their child to participate.

You may not qualify if:

  • Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
  • Patients experiencing serious neurological effects such as posterior fossa syndrome that interfere with their ability to self-report on fatigue and mood.
  • Patient is bedridden and unable to participate in an activity.
  • Patients or parents who would find participating in the consent process too emotionally demanding as determined by the treatment team.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (3)

  • Graef DM, Crabtree VM, Srivastava DK, Li C, Pritchard M, Hinds PS, Mandrell B. Sleep and mood during hospitalization for high-dose chemotherapy and hematopoietic rescue in pediatric medulloblastoma. Psychooncology. 2018 Jul;27(7):1847-1853. doi: 10.1002/pon.4737. Epub 2018 May 16.

    PMID: 29663636RESULT

  • Rogers VE, Zhu S, Mandrell BN, Ancoli-Israel S, Liu L, Hinds PS. Relationship between circadian activity rhythms and fatigue in hospitalized children with CNS cancers receiving high-dose chemotherapy. Support Care Cancer. 2020 Mar;28(3):1459-1467. doi: 10.1007/s00520-019-04960-5. Epub 2019 Jul 4.

    PMID: 31273507RESULT

  • Rogers VE, Zhu S, Ancoli-Israel S, Liu L, Mandrell BN, Hinds PS. A pilot randomized controlled trial to improve sleep and fatigue in children with central nervous system tumors hospitalized for high-dose chemotherapy. Pediatr Blood Cancer. 2019 Aug;66(8):e27814. doi: 10.1002/pbc.27814. Epub 2019 May 13.

    PMID: 31081596RESULT

Related Links

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Belinda Mandrell, PhD, RN, PNP

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2008

First Posted

April 25, 2008

Study Start

April 1, 2008

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

August 19, 2019

Record last verified: 2012-01

Locations

US(1)