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New hope for better sleep after gynecologic cancer: behavioral interventions show promise

NCT ID NCT05044975

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested three behavioral approaches—sleep restriction, stimulus control, and systematic light exposure—to help gynecologic cancer survivors who have trouble sleeping. 78 participants completed the program, and researchers measured changes in sleep quality and daytime impairment. The goal is to find safe, non-drug ways to improve sleep and quality of life for cancer survivors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
behavioral interventions (sleep restriction, stimulus control, systematic light exposure)
What this could lead to
If successful, this could point toward effective non-drug ways to help gynecologic cancer survivors get better sleep and feel more rested.
What could go wrong
This is a small, completed study (78 participants) without a control group, so results may not apply to everyone. Behavioral changes can be hard to maintain long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

78 people

The number who actually took part.

Started

Oct 2021

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611, United States

  • University of Arizona College of Nursing

    Tucson, Arizona, 85721, United States

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