A Pilot Study to Examine Sleep and Fatigue in Pediatric Brain Tumor Patients Hospitalized for High Dose Chemotherapy
Condition: Sleep; Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      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).
    

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.
    

Intervention name(s): Sleep Environment Intervention; Normal Hospital Environment
Intervention type(s): Other; Other
Intervention description(s): 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.; Normal Hospital Environment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Sleep; Fatigue; High Dose Chemotherapy