This study is NOT currently recruiting participants.
Number
000085-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 18 Years Max Age: 99 Years
Referral Letter Required
Yes
Population Exclusion(s)
Adults who are or may become unable to consent;Non-English Speaking;Children
Keywords
Sleep Disturbance; smart wearable; Patient-Reported Outcomes; Natural History
Recruitment Keyword(s)
None
Condition(s)
sleep circadian rhythms; chronodisruption
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
National Cancer Institute
Sleep disturbances are among the most common and severe symptoms reported by people with primary brain tumors (PBT). Smart wearable devices like Fitbits may be able to give detailed data about people s sleep and circadian rhythms. In this study, researchers will use Fitbits to learn more about sleep disruptions caused by tumors. This might help them design better future treatment and supportive care studies.
Objective:
To describe sleep disturbances and circadian disruption in people with PBT.
Eligibility:
English-speaking adults ages 18 and older who have PBT and are enrolled in the NIH study, Evaluation of the Natural History of and Specimen Banking for Patients with Tumors of the Central Nervous System. It is also known as the Natural History Study, trial #16C0151.
Design:
Participants will be screened over the telephone or in person. They will be asked about their medical history. Their cancer diagnosis will be confirmed through test results and pathology reports.
Participants will complete 4 surveys. The surveys take about 20 minutes to complete and will ask about:
The quality of their sleep
Their ability to fall asleep and stay asleep
How the quality of their sleep affects their daily activities
Their sleep hygiene and preferences
Participants will get a Fitbit. It looks like a watch and is worn on the wrist. They will connect the device to their smart phone to track sleep, heart rate, and activity. They will wear it for 1 month.
Participants will keep a daily sleep diary for 1 week. It will be sent via an electronic link. They will also repeat 2 of the surveys.
Participation will last for 1 month.
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INCLUSION CRITERIA: -Subjects with histologically documented PBT -PBT patients must be enrolled on the Natural History Study (NHS) trial 16C0151 in the Neuro-Oncology Branch (NOB). Note: Concurrent enrollment in other NOB trials is also permissible. -Adults (greater than or equal to 18 years of age) who are English-speaking -Participants must be able to self-report symptoms -Ability of subject to understand and the willingness to sign a written consent document EXCLUSION CRITERIA: -Participants who are unwilling or unable to synchronize or link their Fitbit smart wearable device to their personal smart phone or another compatible device.
-Subjects with histologically documented PBT
-PBT patients must be enrolled on the Natural History Study (NHS) trial 16C0151 in the Neuro-Oncology Branch (NOB). Note: Concurrent enrollment in other NOB trials is also permissible.
-Adults (greater than or equal to 18 years of age) who are English-speaking
-Participants must be able to self-report symptoms
-Ability of subject to understand and the willingness to sign a written consent document
EXCLUSION CRITERIA:
-Participants who are unwilling or unable to synchronize or link their Fitbit smart wearable device to their personal smart phone or another compatible device.
Principal Investigator
Referral Contact
For more information: