A Pilot Study to Examine Sleep and Fatigue in Pediatric Brain Tumor Patients Hospitalized for High Dose Chemotherapy
4 Years
21 Years
Both
Sleep, Fatigue
Trial Information
A Pilot Study to Examine Sleep and Fatigue in Pediatric Brain Tumor Patients Hospitalized for High Dose Chemotherapy
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).
All patients enrolled on SJMB03 and admitted to receive either the 2nd or 3rd course of
chemotherapy will be eligible for the study. The patients are admitted for four to six days
and all participants will wear an actigraph to collect information on 8 sleep quality
indicators for each of the six days. In addition, fatigue measurements will also be
collected and compared between the two groups. Given the nature of the intervention, it is
difficult to follow the traditional randomization scheme and randomize eligible patients to
the intervention or standard care because there is a high likelihood of design contamination
secondary to interactions among family members and among the nurses in regards to the
different care for the study participants in the two study groups. Therefore, this study
will use a group randomized trial design with patients randomized by month. That is, all
patients admitted in a month randomized to be an intervention month will receive the
intervention and all patients admitted to a standard care month will not receive the
intervention. This type of randomization plan has notable strengths that match this study
design but it also has two potential challenges: 1) patients randomized within the last five
days of each month will continue to receive the assigned treatment to which they were
randomized although this treatment assignment will continue into a different month that
could have been randomized to the same or different condition as the previous month, and 2)
with random assignments of months to the two treatment arms, there is a possibility of an
unequal distribution of patients randomized to the two groups.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome 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
Outcome Time Frame:
Within 6 -10 months
Safety Issue:
No
Principal Investigator
Belinda Mandrell, PhD, RN, PNP
Investigator Role:
Principal Investigator
Investigator Affiliation:
St. Jude Children's Research Hospital
Authority:
United States: Institutional Review Board
Study ID:
BTSLEP
NCT ID:
NCT00666614
Start Date:
April 2008
Completion Date:
October 2011
Related Keywords:
- Sleep
- Fatigue
- Sleep
- Fatigue
- High Dose Chemotherapy
- Brain Neoplasms
- Fatigue
Name | Location |
|---|---|
| St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
