Status:
COMPLETED
A Pilot Study to Examine Sleep and Fatigue in Pediatric Brain Tumor Patients Hospitalized for High Dose Chemotherapy
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Sleep
Fatigue
Eligibility:
All Genders
4-21 years
Phase:
NA
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 no...
Detailed Description
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 no...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00666614
Start Date
April 1 2008
End Date
October 1 2011
Last Update
August 19 2019
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105