SleepNCT00666614
A Pilot Study to Examine Sleep and Fatigue in Pediatric Brain Tumor Patients Hospitalized for High Dose Chemotherapy
A study testing Sleep Environment Intervention and Normal Hospital Environment in people with Sleep and Fatigue, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 4 to 21 years
- What is being tested?
- Sleep Environment Intervention and Normal Hospital Environment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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).
Read the 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.
- Being tested
- Sleep Environment Intervention, Normal Hospital Environment
- Keywords
- Sleep, Fatigue, High Dose Chemotherapy
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Environment InterventionOther
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 EnvironmentOther
Normal Hospital Environment
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | 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. Receives: Other: Sleep Environment Intervention |
| Standard Care | Other | Normal Hospital Environment Receives: Other: Normal Hospital Environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 6 -10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Belinda Mandrell, PhD, RN, PNP, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666614
- Sponsor's protocol ID
- BTSLEP
- Status last verified
- Jan 2012
- First submitted
- 23 Apr 2008
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Graef DM, Crabtree VM, Srivastava DK, Li C, Pritchard M, Hinds PS, Mandrell B. Sleep and mood during hospitalization for high-dose chemotherapy and hematopoietic rescue in pediatric medulloblastoma. Psychooncology. 2018 Jul;27(7):1847-1853. doi: 10.1002/pon.4737. Epub 2018 May 16.
PubMed 29663636Rogers VE, Zhu S, Mandrell BN, Ancoli-Israel S, Liu L, Hinds PS. Relationship between circadian activity rhythms and fatigue in hospitalized children with CNS cancers receiving high-dose chemotherapy. Support Care Cancer. 2020 Mar;28(3):1459-1467. doi: 10.1007/s00520-019-04960-5. Epub 2019 Jul 4.
PubMed 31273507Rogers VE, Zhu S, Ancoli-Israel S, Liu L, Mandrell BN, Hinds PS. A pilot randomized controlled trial to improve sleep and fatigue in children with central nervous system tumors hospitalized for high-dose chemotherapy. Pediatr Blood Cancer. 2019 Aug;66(8):e27814. doi: 10.1002/pbc.27814. Epub 2019 May 13.
PubMed 31081596
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Examine Sleep and Fatigue in Pediatric Brain Tumor Patients Hospitalized for High Dose Chemotherapy
- ClinicalTrials.gov ID
- NCT00666614
- Acronym / sponsor ID
- BTSLEP
- Keywords
- Sleep, Fatigue, High Dose Chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 25 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: Sleep Environment InterventionPatients 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 | Other | Other: Normal Hospital EnvironmentNormal Hospital Environment |
Who may qualify
- Ages
- 4 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Environment InterventionPatients 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 | Intervention |
| Normal Hospital EnvironmentNormal Hospital Environment | Other | Standard Care |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- Results publication: PubMed 29663636Graef DM, Crabtree VM, Srivastava DK, Li C, Pritchard M, Hinds PS, Mandrell B. Sleep and mood during hospitalization for high-dose chemotherapy and hematopoietic rescue in pediatric medulloblastoma. Psychooncology. 2018 Jul;27(7):1847-1853. doi: 10.1002/pon.4737. Epub 2018 May 16.
- Results publication: PubMed 31273507Rogers VE, Zhu S, Mandrell BN, Ancoli-Israel S, Liu L, Hinds PS. Relationship between circadian activity rhythms and fatigue in hospitalized children with CNS cancers receiving high-dose chemotherapy. Support Care Cancer. 2020 Mar;28(3):1459-1467. doi: 10.1007/s00520-019-04960-5. Epub 2019 Jul 4.
- Results publication: PubMed 31081596Rogers VE, Zhu S, Ancoli-Israel S, Liu L, Mandrell BN, Hinds PS. A pilot randomized controlled trial to improve sleep and fatigue in children with central nervous system tumors hospitalized for high-dose chemotherapy. Pediatr Blood Cancer. 2019 Aug;66(8):e27814. doi: 10.1002/pbc.27814. Epub 2019 May 13.
- St. Jude Children's Research HospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Belinda Mandrell, PhD, RN, PNP principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Environment Intervention and Normal Hospital Environment in people with Sleep and Fatigue, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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 (time frame: Within 6 -10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00666614, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2019.