Sleep Disturbance, Gynecologic Cancer
Conditions
Brief summary
This purpose of this study is to learn about how to provide treatment to gynecologic cancer survivors who have difficulty sleeping.
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.
Interventions
BEHAVIORALSleep restriction
Participants will receive sleep restriction intervention
BEHAVIORALStimulus control
Participants will receive stimulus control intervention
BEHAVIORALSystematic light exposure
Participants will receive systematic light exposure intervention
Sponsors
National Cancer Institute (NCI)
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in subjectively-reported sleep quality 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) | 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. |
| Changes in perceived impairment during wake associated with sleep problems 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) | 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. |
| Changes in objectively-measured sleep outcomes 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) | Wrist actigraphy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| 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) | 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. |
| 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) | 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. |
| 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) | The 27-item Functional Assessment of Cancer Therapy - General (FACT-G) will measure HRQOL. |
| 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) | The 32-item Memorial Symptom Assessment Scale (MSAS) will evaluate symptom burden. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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) | Wrist actigraphy |
| 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) | The night prior to each assessment participants will collect overnight urine to enable analysis of urinary 6-Sulfatoxymelatonin |
Countries
United States
Outcome results
None listed