Protocol Details
Assessing Sleep and Circadian Rhythms in Primary Brain Tumors Patients: An Observational Study
This study is NOT currently recruiting participants.
Summary
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) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
National Cancer Institute |
Background:
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.
Eligibility
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.
Citations:
Armstrong TS, Vera E, Zhou R, Acquaye AA, Sullaway CM, Berger AM, Breton G, Mahajan A, Wefel JS, Gilbert MR, Bondy M, Scheurer ME. Association of genetic variants with fatigue in patients with malignant glioma. Neurooncol Pract. 2018 May;5(2):122-128. doi: 10.1093/nop/npx020. Epub 2017 Sep 19. PMID: 31386001; PMCID: PMC6655500.
Cook JD, Prairie ML, Plante DT. Utility of the Fitbit Flex to evaluate sleep in major depressive disorder: A comparison against polysomnography and wrist-worn actigraphy. J Affect Disord. 2017 Aug 1;217:299-305. doi: 10.1016/j.jad.2017.04.030. Epub 2017 Apr 19. PMID: 28448949; PMCID: PMC5509938.
Armstrong TS, Shade MY, Breton G, Gilbert MR, Mahajan A, Scheurer ME, Vera E, Berger AM. Sleep-wake disturbance in patients with brain tumors. Neuro Oncol. 2017 Mar 1;19(3):323-335. doi: 10.1093/neuonc/now119. PMID: 27286798; PMCID: PMC5464298.
Contacts:
Clinical Trials Number:
NCT04669574