Improving Sleep in Gynecologic Cancer Survivors

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

Detailed Description
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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.

Official Title
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Improving Sleep in Gynecologic Cancer Survivors

Conditions
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Sleep Disturbance, Gynecologic Cancer

Intervention / Treatment
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* Behavioral: Sleep restriction
* Behavioral: Stimulus control
* Behavioral: Systematic light exposure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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) |