Clinical trial · Interventional
A Pilot Study to Examine Sleep and Fatigue in Pediatric Brain Tumor Patients Hospitalized for High Dose Chemotherapy
NCT00666614CI-TRIAL-00040108completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fatigue | — | UNRESOLVED | — |
| Sleep | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Normal Hospital Environment | Other | — | UNRESOLVED |
| Sleep Environment Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Intervention
- description
- 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.
- interventionNames
- Other: Sleep Environment Intervention
- type
- OTHER
- label
- Standard Care
- description
- Normal Hospital Environment
- interventionNames
- Other: Normal Hospital Environment
Primary outcomes (1)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (3)
- RESULTGraef 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 29663636
- RESULTRogers 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 31273507
- RESULTRogers 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 31081596