Improving Sleep in Gynecologic Cancer Survivors

NCT05044975 | Active Not Recruiting

• 2 other identifiers: STU00213356K08CA247973
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Sleep Disturbance; Gynecologic Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

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

  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

  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

  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

  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

  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 Outcomes (2)

• Changes in circadian activity rhythms from baseline to immediately after the intervention and 3-months post-intervention

  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

  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)

Study Arms (8)

Sleep restriction, Stimulus control, and Systematic light exposure

EXPERIMENTAL

Behavioral: Sleep restriction; Behavioral: Stimulus control; Behavioral: Systematic light exposure

Sleep restriction and Stimulus control

EXPERIMENTAL

Behavioral: Sleep restriction; Behavioral: Stimulus control

Sleep restriction and Systematic light exposure

EXPERIMENTAL

Behavioral: Sleep restriction; Behavioral: Systematic light exposure

Stimulus control and Systematic light exposure

EXPERIMENTAL

Behavioral: Stimulus control; Behavioral: Systematic light exposure

Sleep Restriction

EXPERIMENTAL

Behavioral: Sleep restriction

Stimulus control

EXPERIMENTAL

Behavioral: Stimulus control

Systematic light exposure

EXPERIMENTAL

Behavioral: Systematic light exposure

Sleep tracking

NO INTERVENTION

Interventions

Sleep restriction BEHAVIORAL

Participants will receive sleep restriction intervention

Sleep Restriction; Sleep restriction and Stimulus control; Sleep restriction and Systematic light exposure; Sleep restriction, Stimulus control, and Systematic light exposure

Stimulus control BEHAVIORAL

Participants will receive stimulus control intervention

Sleep restriction and Stimulus control; Sleep restriction, Stimulus control, and Systematic light exposure; Stimulus control; Stimulus control and Systematic light exposure

Systematic light exposure BEHAVIORAL

Participants will receive systematic light exposure intervention

Sleep restriction and Systematic light exposure; Sleep restriction, Stimulus control, and Systematic light exposure; Stimulus control and Systematic light exposure; Systematic light exposure

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Arizona College of Nursing

Tucson, Arizona, 85721, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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.

  PMID: 35310101 DERIVED

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 16, 2021
• Study Start: October 11, 2021
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)