Improving Sleep in Gynecologic Cancer Survivors

N/AActive Not RecruitingNCT05044975

University of Arizona95 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Sleep Disturbance Gynecologic Cancer

Interventions

Sleep restrictionBEHAVIORAL

Participants will receive sleep restriction intervention

Stimulus controlBEHAVIORAL

Participants will receive stimulus control intervention

Systematic light exposureBEHAVIORAL

Participants will receive systematic light exposure intervention

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

University of Arizona College of Nursing

Tucson, Arizona, United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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

Wrist actigraphy

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)

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.

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)

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.

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)

Secondary Outcomes

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.

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)

Data from ClinicalTrials.gov

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