Pediatric Cancer PatientsNCT02836041
Sleep in Hospitalized Children at MSKCC
An observational study of Pediatric Cancer Patients, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The investigators want to better understand how children sleep at night at MSKCC, so that the investigators can learn how to improve the sleeping environment. Read more about this study
- Who is it for?
- Ages 0 months to 18 years
- Conditions the study is for
- Pediatric Cancer Patients
- What is being tested?
- questionnaires and actigraph
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2016to 26 May 2021
- Phase
- Observational
- 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 0 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All eligible patients admitted to the pediatric floor at MSK.
Who may be able to join
- Parent/Patient must provide written consent
- Patient must be between the ages of: Newborn - ≤ 18 years of age
- Patient is expected to be admitted to the Pediatric floor at MSK for at least 2 nights (patients/parents will not be approached for consent on day of admission or day of discharge)
- Patient/parent must be English speaking
Who cannot join
- Expected length of stay of fewer than 2 nights (for example.: if admitted Monday and discharged Tuesday, patient/parent will not be eligible).
- Patient /Parent unable to complete questionnaire due to education or language barriers.
- Patients admitted to the PICU. (Only children on M9 will be included. It is known that sleep in the PICU is highly disordered; as such, we will be excluding PICU patients from this study).
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Pilot Study: Sleep in Hospitalized Children With Cancer and Related Diseases
The investigators want to better understand how children sleep at night at MSKCC, so that the investigators can learn how to improve the sleeping environment.
- Conditions
- Pediatric Cancer Patients
- Being tested
- questionnaires, actigraph
- Keywords
- assess sleep, Sleep Deprivation, 16-866
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesBehavioural
Pre-hospital sleep questionnaire completed (Brief Infant Sleep Questionnaire (BISQ)7 in children 0-3 years old; Children's Sleep Habits Questionnaire (CSHQ)8 in children 4 years and older). Subsequent Day(s):
In-hospital sleep questionnaire completed between one and three times per subject (Sleep at MSK questionnaire (SAM), adapted from Sleep in a Children's Hospital (SinCH)9 by Dr. Lisa Meltzer). (Patients will be observed for up to 3 consecutive nights in total).
actigraphDevice
This device reliably measures sleep by monitoring the child's motion.
| Study group | Role | What they receive |
|---|---|---|
| Pediatrics cancer patients | Eligible patients will be approached for enrollment after their first night in the hospital (i.e.: not on day of admission). Patient/parent will be asked to complete a brief questionnaire describing the child's general sleep habits prior to admission. The parent and/or child will then be asked to complete a questionnaire describing sleep while in the hospital; this in-hospital sleep questionnaire will be obtained for 3 consecutive nights after enrollment, or until discharge, whichever is soonest. A subgroup of patients (between the ages of 5 and 18) will be invited to participate in an additional aspect of the study, where they wear an actigraph (a small device that looks like a watch) for up to 72 hours. This device reliably measures sleep by monitoring the child's motion. This will be used to relate sleep perception to more objective measures of sleep as provided by actigraphy. Receives: Behavioral: questionnaires; Device: actigraph |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of sleep
(using the Sleep at MSK questionnaire)
Measured: 3 nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study start7 Jul 2016
- Primary completion26 May 2021
- Study completion26 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chani Traube, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836041
- Sponsor's protocol ID
- 16-866
- Status last verified
- May 2021
- First submitted
- 14 Jul 2016
- Last updated
- 28 May 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study: Sleep in Hospitalized Children With Cancer and Related Diseases
- ClinicalTrials.gov ID
- NCT02836041
- Acronym / sponsor ID
- 16-866
- Conditions
- Pediatric Cancer Patients
- Keywords
- assess sleep, Sleep Deprivation, 16-866
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Johns Hopkins University, Weill Medical College of Cornell University
- Study start
- 7 Jul 2016 (actual)
- Primary completion
- 26 May 2021 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 18 Jul 2016 (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 investigators want to better understand how children sleep at night at MSKCC, so that the investigators can learn how to improve the sleeping environment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatrics cancer patients | – | Behavioral: questionnaires, Device: actigraphEligible patients will be approached for enrollment after their first night in the hospital (i.e.: not on day of admission). Patient/parent will be asked to complete a brief questionnaire describing the child's general sleep habits prior to admission. The parent and/or child will then be asked to complete a questionnaire describing sleep while in the hospital; this in-hospital sleep questionnaire will be obtained for 3 consecutive nights after enrollment, or until discharge, whichever is soonest. A subgroup of patients (between the ages of 5 and 18) will be invited to participate in an additional aspect of the study, where they wear an actigraph (a small device that looks like a watch) for up to 72 hours. This device reliably measures sleep by monitoring the child's motion. This will be used to relate sleep perception to more objective measures of sleep as provided by actigraphy. |
Who may qualify
- Ages
- 0 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All eligible patients admitted to the pediatric floor at MSK.
Key inclusion criteria (4 listed)
- Parent/Patient must provide written consent
- Patient must be between the ages of: Newborn - ≤ 18 years of age
- Patient is expected to be admitted to the Pediatric floor at MSK for at least 2 nights (patients/parents will not be approached for consent on day of admission or day of discharge)
- Patient/parent must be English speaking
Key exclusion criteria (3 listed)
- Expected length of stay of fewer than 2 nights (for example.: if admitted Monday and discharged Tuesday, patient/parent will not be eligible).
- Patient /Parent unable to complete questionnaire due to education or language barriers.
- Patients admitted to the PICU. (Only children on M9 will be included. It is known that sleep in the PICU is highly disordered; as such, we will be excluding PICU patients from this study).
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 |
|---|---|---|
| questionnairesPre-hospital sleep questionnaire completed (Brief Infant Sleep Questionnaire (BISQ)7 in children 0-3 years old; Children's Sleep Habits Questionnaire (CSHQ)8 in children 4 years and older). Subsequent Day(s): In-hospital sleep questionnaire completed between one and three times per subject (Sleep at MSK questionnaire (SAM), adapted from Sleep in a Children's Hospital (SinCH)9 by Dr. Lisa Meltzer). (Patients will be observed for up to 3 consecutive nights in total). | Behavioural | Pediatrics cancer patients |
| actigraphThis device reliably measures sleep by monitoring the child's motion. | Device | Pediatrics cancer patients |
Primary outcome
quality of sleep
Time frame: 3 nights
(using the Sleep at MSK questionnaire)
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 28 May 2021.
- Memorial Sloan Kettering Cancer CenterLink 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.
Chani Traube, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Cancer Patients, run by Memorial Sloan Kettering Cancer Center 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 4 inclusion and 3 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 28 May 2021. 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?
quality of sleep (time frame: 3 nights). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2021.