Fatigue Clinical Trial
Official title:
A Pilot Study to Examine Sleep and Fatigue in Pediatric Brain Tumor Patients Hospitalized for High Dose Chemotherapy
NCT number | NCT00666614 |
Other study ID # | BTSLEP |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2008 |
Est. completion date | October 2011 |
Verified date | January 2012 |
Source | St. Jude Children's Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 43 |
Est. completion date | October 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 21 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
St. Jude Children's Research Hospital |
United States,
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/p — View Citation
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): — View Citation
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. 2019 Jul 4. doi: 10.1007/s00520-0 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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