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Sleep DisturbanceNCT05044975

Improving Sleep in Gynecologic Cancer Survivors

A study testing Sleep restriction and Systematic light exposure in people with Sleep Disturbance and Gynecologic Cancer, run by University of Arizona at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This purpose of this study is to learn about how to provide treatment to gynecologic cancer survivors who have difficulty sleeping. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Sleep Disturbance, Gynecologic Cancer
What is being tested?
Sleep restriction and Systematic light exposure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
2 sitesUnited States
Study dates
11 Oct 2021to 7 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 11Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

  • University of Arizona College of Nursing

    Tucson, Arizona, 85721

Other trials in United States

About this study

This purpose of this study is to learn about how to provide treatment to gynecologic cancer survivors who have difficulty sleeping.

Read the detailed description

This study has two parts.

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.

Being tested
Sleep restriction, Stimulus control, Systematic light exposure
Medical subject headings
Parasomnias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sleep restrictionBehavioural

    Participants will receive sleep restriction intervention

  • Stimulus controlBehavioural

    Participants will receive stimulus control intervention

  • Systematic light exposureBehavioural

    Participants will receive systematic light exposure intervention

Study groups in NCT05044975
Study groupRoleWhat they receive
Sleep restriction, Stimulus control, and Systematic light exposureExperimentalNot described
Receives: Behavioral: Sleep restriction; Behavioral: Stimulus control; Behavioral: Systematic light exposure
Sleep restriction and Stimulus controlExperimentalNot described
Receives: Behavioral: Sleep restriction; Behavioral: Stimulus control
Sleep restriction and Systematic light exposureExperimentalNot described
Receives: Behavioral: Sleep restriction; Behavioral: Systematic light exposure
Stimulus control and Systematic light exposureExperimentalNot described
Receives: Behavioral: Stimulus control; Behavioral: Systematic light exposure
Sleep RestrictionExperimentalNot described
Receives: Behavioral: Sleep restriction
Stimulus controlExperimentalNot described
Receives: Behavioral: Stimulus control
Systematic light exposureExperimentalNot described
Receives: Behavioral: Systematic light exposure
Sleep trackingNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in objectively-measured sleep outcomes from baseline to immediately after the intervention and 3-months post-intervention

    Wrist actigraphy

    Measured: Baseline (Part 1 and Part 2 participants), immediately after the intervention (Part 1 and Part 2 participants), 3-months post-intervention (Part 2 participants only)

  2. Changes in subjectively-reported sleep quality from baseline to immediately after the intervention and 3-months post-intervention

    Subjectively-reported sleep quality over the past 7 days will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance questionnaire. Raw scores will be converted to T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate more of the underlying construct.

    Measured: Baseline (Part 1 and Part 2 participants), immediately after the intervention (Part 1 and Part 2 participants), 3-months post-intervention (Part 2 participants only)

  3. Changes in perceived impairment during wake associated with sleep problems from baseline to immediately after the intervention and 3-months post-intervention

    Perceived impairment during wake associated with sleep problems over the past seven days will be measured with the PROMIS Sleep-Related Impairment questionnaire. Raw scores will be converted to T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate more of the underlying construct.

    Measured: Baseline (Part 1 and Part 2 participants), immediately after the intervention (Part 1 and Part 2 participants), 3-months post-intervention (Part 2 participants only)

Secondary outcomes (5)

  1. Changes in health-related quality of life (HRQOL) from baseline to immediately after the intervention and 3-months post-intervention

    The 27-item Functional Assessment of Cancer Therapy - General (FACT-G) will measure HRQOL.

    Measured: Baseline (Part 1 and Part 2 participants), immediately after the intervention (Part 1 and Part 2 participants), 3-months post-intervention (Part 2 participants only)

  2. Changes in overall symptom burden from baseline to immediately after the intervention and 3-months post-intervention

    The 32-item Memorial Symptom Assessment Scale (MSAS) will evaluate symptom burden.

    Measured: Baseline (Part 1 and Part 2 participants), immediately after the intervention (Part 1 and Part 2 participants), 3-months post-intervention (Part 2 participants only)

  3. Changes in symptoms of depression from baseline to immediately after the intervention and 3-months post-intervention

    Symptoms of depression over the past seven days with be measured with the PROMIS Depression questionnaire. Raw scores will be converted to T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate more of the underlying construct.

    Measured: Baseline (Part 1 and Part 2 participants), immediately after the intervention (Part 1 and Part 2 participants), 3-months post-intervention (Part 2 participants only)

  4. Changes in symptoms of anxiety from baseline to immediately after the intervention and 3-months post-intervention

    Symptoms of anxiety over the past seven days with be measured with the PROMIS Anxiety questionnaire. Raw scores will be converted to T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate more of the underlying construct.

    Measured: Baseline (Part 1 and Part 2 participants), immediately after the intervention (Part 1 and Part 2 participants), 3-months post-intervention (Part 2 participants only)

  5. Changes in fatigue from baseline to immediately after the intervention and 3-months post-intervention

    Fatigue over the past seven days with be measured with the PROMIS Fatigue questionnaire. Raw scores will be converted to T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate more of the underlying construct.

    Measured: Baseline (Part 1 and Part 2 participants), immediately after the intervention (Part 1 and Part 2 participants), 3-months post-intervention (Part 2 participants only)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2021
  2. Study start11 Oct 2021
  3. Primary completion7 Aug 2025
  4. Study completion7 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05044975
Sponsor's protocol ID
STU00213356
Other IDs
K08CA247973
Status last verified
May 2026
First submitted
3 Sep 2021
Last updated
22 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35310101

Questions about this trial

What is this clinical trial studying?

A study testing Sleep restriction and Systematic light exposure in people with Sleep Disturbance and Gynecologic Cancer, run by University of Arizona at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in objectively-measured sleep outcomes from baseline to immediately after the intervention and 3-months post-intervention (time frame: Baseline (Part 1 and Part 2 participants), immediately after the intervention (Part 1 and Part 2 participants), 3-months post-intervention (Part 2 participants only)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05044975, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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