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| ID | Type | Description | Link |
|---|---|---|---|
| K08CA247973 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep restriction, Stimulus control, and Systematic light exposure | Experimental |
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| Sleep restriction and Stimulus control | Experimental |
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| Sleep restriction and Systematic light exposure | Experimental |
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| Stimulus control and Systematic light exposure | Experimental |
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| Sleep Restriction | Experimental |
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| Stimulus control | Experimental |
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| Systematic light exposure |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep restriction | Behavioral | Participants will receive sleep restriction intervention |
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| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in circadian activity rhythms 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 urinary 6-Sulfatoxymelatonin from baseline to immediately after the intervention and 3-months post-intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona College of Nursing | Tucson | Arizona | 85721 | United States | ||
| Northwestern University Feinberg School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35310101 | Derived | 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. |
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| Sleep tracking | No Intervention |
| Stimulus control | Behavioral | Participants will receive stimulus control intervention |
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| Systematic light exposure | Behavioral | Participants will receive systematic light exposure intervention |
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| 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) |
The night prior to each assessment participants will collect overnight urine to enable analysis of urinary 6-Sulfatoxymelatonin |
| 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) |
| Chicago |
| Illinois |
| 60611 |
| United States |