Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
95 participants
INTERVENTIONAL
2021-10-11
2026-01-31
Brief Summary
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Detailed Description
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In Part 1, 15 gynecologic cancer survivors will receive three candidate intervention components known to reduce sleep disturbance (i.e., sleep restriction, stimulus control, systematic light exposure) simultaneously for six weeks. Participants will then complete semi-structured individual interviews to provide feedback about barriers to and facilitators of intervention adherence. Results of Part 1 will inform the design and delivery of the candidate components in Part 2.
In Part 2, a 2\^3 full factorial design will be followed to randomize 80 gynecologic cancer survivors to one of eight six-week intervention conditions reflecting all possible combinations of the three candidate intervention components.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
NONE
Study Groups
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Sleep restriction, Stimulus control, and Systematic light exposure
Sleep restriction
Participants will receive sleep restriction intervention
Stimulus control
Participants will receive stimulus control intervention
Systematic light exposure
Participants will receive systematic light exposure intervention
Sleep restriction and Stimulus control
Sleep restriction
Participants will receive sleep restriction intervention
Stimulus control
Participants will receive stimulus control intervention
Sleep restriction and Systematic light exposure
Sleep restriction
Participants will receive sleep restriction intervention
Systematic light exposure
Participants will receive systematic light exposure intervention
Stimulus control and Systematic light exposure
Stimulus control
Participants will receive stimulus control intervention
Systematic light exposure
Participants will receive systematic light exposure intervention
Sleep Restriction
Sleep restriction
Participants will receive sleep restriction intervention
Stimulus control
Stimulus control
Participants will receive stimulus control intervention
Systematic light exposure
Systematic light exposure
Participants will receive systematic light exposure intervention
Sleep tracking
No interventions assigned to this group
Interventions
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Sleep restriction
Participants will receive sleep restriction intervention
Stimulus control
Participants will receive stimulus control intervention
Systematic light exposure
Participants will receive systematic light exposure intervention
Eligibility Criteria
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Inclusion Criteria
* Age 18+ years
* English language proficiency
* Current sleep disturbance demonstrated by a Pittsburgh Sleep Quality Index (PSQI) score \> 5
* Usual sleep onset time between 9:00PM and 3:00AM
* Reliable telephone and Internet access
Exclusion Criteria
* Diagnosed or suspected psychiatric or medical condition that may interfere with participation (e.g., psychosis, dementia, bipolar disorder, abuse of alcohol or illicit substances within the past 6 months, narrow angle glaucoma, retinal disorders, epilepsy or a similar condition)
* Diagnosed sleep apnea, narcolepsy, periodic limb movement disorder, or restless legs syndrome unless well controlled
* Use of medications that may be contraindications for study procedures due to safety concerns or due to potential impact on intervention efficacy or assessment validity (e.g., sedatives/hypnotics), to be identified on a case-by-case basis
* Shift worker
* Severe physical or cognitive impairment (≥ 2 errors on a brief six-item version of the Mini Mental State Exam \[MMSE\] or Patient Reported Functional Status \[PRFS\] score \> 2, which is based on the Eastern Cooperative Oncology Group \[ECOG\]but has been modified to be in lay language)
* Plans to travel across 3 or more meridians/time zones during the 6 intervention weeks or plans to cross any meridians/time zones during the 2 weeks leading up to wearing an actiwatch.
* History of a primary diagnosis of a distinct non-gynecologic or non-skin cancer other than a non-melanoma skin cancer within the 5 years prior to enrollment
* For participants with Stage III ovarian cancer: less than 2 years post-completion of primary gynecologic cancer treatment and/or less than 60 days post-surgery. For patients with any other gynecologic cancer/stage: less than 30 days post-completion of primary gynecologic cancer treatment and/or less than 60 days post-surgical intervention (e.g., hysterectomy)
* Male
* Have received CBT-I or systematic bright light therapy within the past 6 months
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Arizona
OTHER
Responsible Party
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Rina Fox
Assistant Professor
Locations
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University of Arizona College of Nursing
Tucson, Arizona, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Countries
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References
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Fox RS, Gaumond JS, Zee PC, Kaiser K, Tanner EJ, Ancoli-Israel S, Siddique J, Penedo FJ, Wu LM, Reid KJ, Parthasarathy S, Badger TA, Rini C, Ong JC. Optimizing a Behavioral Sleep Intervention for Gynecologic Cancer Survivors: Study Design and Protocol. Front Neurosci. 2022 Mar 4;16:818718. doi: 10.3389/fnins.2022.818718. eCollection 2022.
Other Identifiers
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STU00213356
Identifier Type: -
Identifier Source: org_study_id
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