Clinical trial · Interventional
Improving Sleep in Gynecologic Cancer Survivors
NCT05044975CI-TRIAL-00112322completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This purpose of this study is to learn about how to provide treatment to gynecologic cancer survivors who have difficulty sleeping.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Sleep Disturbance | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sleep restriction | Behavioral | — | UNRESOLVED |
| Stimulus control | Behavioral | — | UNRESOLVED |
| Systematic light exposure | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- Sleep restriction, Stimulus control, and Systematic light exposure
- interventionNames
- Behavioral: Sleep restriction
- Behavioral: Stimulus control
- Behavioral: Systematic light exposure
- type
- EXPERIMENTAL
- label
- Sleep restriction and Stimulus control
- interventionNames
- Behavioral: Sleep restriction
- Behavioral: Stimulus control
- type
- EXPERIMENTAL
- label
- Sleep restriction and Systematic light exposure
- interventionNames
- Behavioral: Sleep restriction
- Behavioral: Systematic light exposure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * History of Stage I, II, or III gynecologic cancer * 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: * Stage IV disease * 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
References
Publications (1)
- DERIVEDFox 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. PMID 35310101