Improving Sleep in Gynecologic Cancer Survivors

University of Arizona

Status: Active, not recruiting

Conditions: Gynecologic Cancer; Sleep Disturbance

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05044975

K08CA247973 (U.S. NIH Grant/Contract)

STU00213356

Details and patient eligibility

About

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

Full 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.

Enrollment: 95 estimated patients

Sex: Female

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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95 participants in 8 patient groups

Sleep restriction, Stimulus control, and Systematic light exposure

Experimental group

Treatment:

Behavioral: Systematic light exposure

Behavioral: Sleep restriction

Behavioral: Stimulus control

Sleep restriction and Stimulus control

Experimental group

Treatment:

Behavioral: Sleep restriction

Behavioral: Stimulus control

Sleep restriction and Systematic light exposure

Experimental group

Treatment:

Behavioral: Systematic light exposure

Behavioral: Sleep restriction

Stimulus control and Systematic light exposure

Experimental group

Treatment:

Behavioral: Systematic light exposure

Behavioral: Stimulus control

Sleep Restriction

Experimental group

Treatment:

Behavioral: Sleep restriction

Stimulus control

Experimental group

Treatment:

Behavioral: Stimulus control

Systematic light exposure

Experimental group

Treatment:

Behavioral: Systematic light exposure

Sleep tracking

No Intervention group