A Pilot Study to Examine Sleep and Fatigue in Pediatric Brain Tumor Patients Hospitalized for High Dose Chemotherapy

Completed · Not applicable

Conditions studied: Sleep, Fatigue

In brief

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).

Key facts

Study ID

NCT00666614

Run by

St. Jude Children's Research Hospital

People needed

43

Starts

2008-04-01

Expected to finish

2011-10-01

Last updated by the study team

2019-08-19

Who can join

Age: 4 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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