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A Pilot Study to Examine Sleep and Fatigue in Pediatric Brain Tumor Patients Hospitalized for High Dose Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00666614
First received: April 23, 2008
Last updated: January 3, 2012
Last verified: January 2012
  Purpose

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).


Condition Intervention
Sleep
Fatigue
Other: Sleep Environment Intervention
Other: Normal Hospital Environment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Pilot Study to Examine Sleep and Fatigue in Pediatric Brain Tumor Patients Hospitalized for High Dose Chemotherapy

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • 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 [ Time Frame: Within 6 -10 months ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: April 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intervention
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.
Other: Sleep Environment Intervention
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.
Standard Care
Normal Hospital Environment
Other: Normal Hospital Environment
Normal Hospital Environment

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 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.

  Eligibility

Ages Eligible for Study:   4 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666614

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Belinda Mandrell, PhD, RN, PNP St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00666614     History of Changes
Other Study ID Numbers: BTSLEP
Study First Received: April 23, 2008
Last Updated: January 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Sleep
Fatigue
High Dose Chemotherapy

Additional relevant MeSH terms:
Brain Neoplasms
Fatigue
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms
Signs and Symptoms

ClinicalTrials.gov processed this record on November 23, 2014