A Pilot Study to Examine Sleep and Fatigue in Pediatric Brain Tumor Patients Hospitalized for High Dose Chemotherapy - NCT00666614-38105 (Clinical Trial 390577)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy390577.aspx
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| City: |
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Memphis |
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State:
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TN |
| Zip Code: |
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38105 |
| Conditions: |
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Sleep - Fatigue |
| Purpose: |
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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).
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| Study summary: |
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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 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. |
| Criteria: |
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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. |
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| Study is available at: |
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St. Jude Children's Research Hospital
Memphis, TN 38105
United States
Primary Contact:
Belinda Mandrell, PhD, RN, PNP
Phone: 866-278-5833
Secondary Contact:
Belinda Mandrell, PhD, RN, PNP
Email: info@stjude.org
Phone: 1-866-278-5833 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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