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

August 15, 2019 updated by: St. Jude Children's Research Hospital
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • St. Jude Children's Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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.
OTHER: Standard Care
Normal Hospital Environment
Other: Normal Hospital Environment
Normal Hospital Environment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Within 6 -10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Jude Children's Research Hospital

Investigators

  • Principal Investigator: Belinda Mandrell, PhD, RN, PNP, St. Jude Children's Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

April 23, 2008

First Submitted That Met QC Criteria

April 24, 2008

First Posted (ESTIMATE)

April 25, 2008

Study Record Updates

Last Update Posted (ACTUAL)

August 19, 2019

Last Update Submitted That Met QC Criteria

August 15, 2019

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTSLEP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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