Improving Sleep in Gynecologic Cancer Survivors

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

Study Overview

• Status: Completed
• Conditions: Gynecologic Cancer; Sleep Disturbance
• Intervention / Treatment: Behavioral: Sleep restriction; Behavioral: Stimulus control; Behavioral: Systematic light exposure

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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85721
      • University of Arizona College of Nursing
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep restriction, Stimulus control, and Systematic light exposure	Behavioral: Sleep restriction; Participants will receive sleep restriction intervention; Behavioral: Stimulus control; Participants will receive stimulus control intervention; Behavioral: Systematic light exposure; Participants will receive systematic light exposure intervention
Experimental: Sleep restriction and Stimulus control	Behavioral: Sleep restriction; Participants will receive sleep restriction intervention; Behavioral: Stimulus control; Participants will receive stimulus control intervention
Experimental: Sleep restriction and Systematic light exposure	Behavioral: Sleep restriction; Participants will receive sleep restriction intervention; Behavioral: Systematic light exposure; Participants will receive systematic light exposure intervention
Experimental: Stimulus control and Systematic light exposure	Behavioral: Stimulus control; Participants will receive stimulus control intervention; Behavioral: Systematic light exposure; Participants will receive systematic light exposure intervention
Experimental: Sleep Restriction	Behavioral: Sleep restriction; Participants will receive sleep restriction intervention
Experimental: Stimulus control	Behavioral: Stimulus control; Participants will receive stimulus control intervention
Experimental: Systematic light exposure	Behavioral: Systematic light exposure; Participants will receive systematic light exposure intervention
No Intervention: Sleep tracking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in objectively-measured sleep outcomes from baseline to immediately after the intervention and 3-months post-intervention	Wrist actigraphy	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)
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.	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)
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)
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.	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)
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.	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)
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.	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)
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.	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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in circadian activity rhythms from baseline to immediately after the intervention and 3-months post-intervention	Wrist actigraphy	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)
Changes in urinary 6-Sulfatoxymelatonin from baseline to immediately after the intervention and 3-months post-intervention	The night prior to each assessment participants will collect overnight urine to enable analysis of urinary 6-Sulfatoxymelatonin	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)

Collaborators and Investigators

• Sponsor: University of Arizona
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2021
• Primary Completion (Actual): August 7, 2025
• Study Completion (Actual): August 7, 2025

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: September 11, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Parasomnias
• Other Study ID Numbers: STU00213356; K08CA247973 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No