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| ID | Type | Description | Link |
|---|---|---|---|
| 517176-1 | Registry Identifier | SUNY UB IRB | |
| 1R15NR013779-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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The purpose of this study is to determine whether cognitive behavioral therapy (CBT) is effective for insomnia in lung cancer survivors.
A randomized controlled clinical trial will be used to test the efficacy of this brief CBT-I compared to attention control on sleep, mood, functional status and quality of life in lung cancer survivors and evaluate the feasibility of translating an evidence-based CBT-I into the clinical setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy eating control | Active Comparator | Healthy eating control involves healthy eating content delivered in a 90 minute group session with two follow up phone calls. |
|
| Cognitive behavioral therapy | Experimental | Cognitive behavioral therapy for insomnia includes content on sleep restriction, stimulus control, relaxation, cognitive restructuring and sleep hygiene content delivered in a 90 minute group intervention with two follow up phone calls. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavioral therapy for insomnia | Behavioral | Cognitive behavioral therapy for insomnia includes content on sleep restriction, stimulus control, relaxation, cognitive restructuring and sleep hygiene content delivered in a 90 minute group intervention with two follow up phone calls. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Efficiency | Sleep Efficiency > 85% measured with a seven-day sleep diary. The score is calculated based on participants' recording of time asleep (minutes) divided by time in bed (minutes). Sleep Efficiency greater than or equal to 85% indicates good sleep quality, and values less than 85% indicate poor sleep quality. | 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne Dickerson, RN, PhD | SUNY University at Buffalo School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SUNY University at Buffalo | Buffalo | New York | 14214 | United States | ||
| Roswell Park Cancer Institute Thoracic Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17326546 | Background | Edinger JD, Wohlgemuth WK, Radtke RA, Coffman CJ, Carney CE. Dose-response effects of cognitive-behavioral insomnia therapy: a randomized clinical trial. Sleep. 2007 Feb;30(2):203-12. doi: 10.1093/sleep/30.2.203. | |
| 12683477 | Background | Edinger JD, Sampson WS. A primary care "friendly" cognitive behavioral insomnia therapy. Sleep. 2003 Mar 15;26(2):177-82. doi: 10.1093/sleep/26.2.177. |
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Data have been prepared for sharing with other investigators. All collected individual participant data (IPD) can be accessed at our data repository.
Data will be made available one year after publication of the study findings manuscript.
IPD will be publicly available to the public via a data repository.
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Four participants were excluded from the study after screening positive (e.g. > or = to 15) on the overnight ApneaLink test and referred to sleep medicine for further assessment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Eating Control | Healthy eating control involves healthy eating content delivered in a 90 minute group session with two follow up phone calls. Healthy eating control: Healthy eating control involves healthy eating content delivered in a 90 minute group session with two follow up phone calls. |
| FG001 | Cognitive Behavioral Therapy | Cognitive behavioral therapy for insomnia includes content on sleep restriction, stimulus control, relaxation, cognitive restructuring and sleep hygiene content delivered in a 90 minute group intervention with two follow up phone calls. Cognitive behavioral therapy for insomnia: Cognitive behavioral therapy for insomnia includes content on sleep restriction, stimulus control, relaxation, cognitive restructuring and sleep hygiene content delivered in a 90 minute group intervention with two follow up phone calls. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Eating Control | Healthy eating control involves healthy eating content delivered in a 90 minute group session with two follow up phone calls. Healthy eating control: Healthy eating control involves healthy eating content delivered in a 90 minute group session with two follow up phone calls. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sleep Efficiency | Sleep Efficiency > 85% measured with a seven-day sleep diary. The score is calculated based on participants' recording of time asleep (minutes) divided by time in bed (minutes). Sleep Efficiency greater than or equal to 85% indicates good sleep quality, and values less than 85% indicate poor sleep quality. | Posted | Mean | Standard Deviation | percentage of sleep efficiency | 5 weeks |
|
one month
Daytime Sleepiness
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Eating Control | Healthy eating control involves healthy eating content delivered in a 90 minute group session with two follow up phone calls. Healthy eating control: Healthy eating control involves healthy eating content delivered in a 90 minute group session with two follow up phone calls. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suzanne S. Dickerson | University at Buffalo School of Nursing | 716-829-3254 | sdickers@buffalo.edu |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| Healthy eating control | Behavioral | Healthy eating control involves healthy eating content delivered in a 90 minute group session with two follow up phone calls. |
|
| Buffalo |
| New York |
| 14263 |
| United States |
| 16777060 | Background | Germain A, Shear MK, Hall M, Buysse DJ. Effects of a brief behavioral treatment for PTSD-related sleep disturbances: a pilot study. Behav Res Ther. 2007 Mar;45(3):627-32. doi: 10.1016/j.brat.2006.04.009. Epub 2006 Jun 14. |
| 18591549 | Background | Espie CA, Fleming L, Cassidy J, Samuel L, Taylor LM, White CA, Douglas NJ, Engleman HM, Kelly HL, Paul J. Randomized controlled clinical effectiveness trial of cognitive behavior therapy compared with treatment as usual for persistent insomnia in patients with cancer. J Clin Oncol. 2008 Oct 1;26(28):4651-8. doi: 10.1200/JCO.2007.13.9006. Epub 2008 Jun 30. |
| 16858458 | Background | Vena C, Parker K, Allen R, Bliwise D, Jain S, Kimble L. Sleep-wake disturbances and quality of life in patients with advanced lung cancer. Oncol Nurs Forum. 2006 Jul 1;33(4):761-9. doi: 10.1188/06.ONF.761-769. |
| 17352006 | Background | Davidson JR, Feldman-Stewart D, Brennenstuhl S, Ram S. How to provide insomnia interventions to people with cancer: insights from patients. Psychooncology. 2007 Nov;16(11):1028-38. doi: 10.1002/pon.1183. |
| 23989018 | Background | Dean GE, Redeker NS, Wang YJ, Rogers AE, Dickerson SS, Steinbrenner LM, Gooneratne NS. Sleep, mood, and quality of life in patients receiving treatment for lung cancer. Oncol Nurs Forum. 2013 Sep;40(5):441-51. doi: 10.1188/13.ONF.441-451. |
| 41170811 | Derived | Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2. |
| 31672070 | Derived | Dean GE, Weiss C, Jungquist CR, Klimpt ML, Alameri R, Ziegler PA, Steinbrenner LM, Dexter EU, Dhillon SS, Lucke JF, Dickerson SS. Nurse-Delivered Brief Behavioral Treatment for Insomnia in Lung Cancer Survivors: A Pilot RCT. Behav Sleep Med. 2020 Nov-Dec;18(6):774-786. doi: 10.1080/15402002.2019.1685523. Epub 2019 Oct 31. |
| Withdrawal by Subject |
|
| Cognitve Behaviroal Therapy |
Cognitive behavioral therapy for insomnia includes content on sleep restriction, stimulus control, relaxation, cognitive restructuring and sleep hygiene content delivered in a 90 minute group intervention with two follow up phone calls. Cognitive behavioral therapy for insomnia: Cognitive behavioral therapy for insomnia includes content on sleep restriction, stimulus control, relaxation, cognitive restructuring and sleep hygiene content delivered in a 90 minute group intervention with two follow up phone calls. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 1 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Cognitve Behaviroal Therapy | Cognitive behavioral therapy for insomnia includes content on sleep restriction, stimulus control, relaxation, cognitive restructuring and sleep hygiene content delivered in a 90 minute group intervention with two follow up phone calls. Cognitive behavioral therapy for insomnia: Cognitive behavioral therapy for insomnia includes content on sleep restriction, stimulus control, relaxation, cognitive restructuring and sleep hygiene content delivered in a 90 minute group intervention with two follow up phone calls. | 0 | 14 | 0 | 14 | 0 | 14 |
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| D001523 |
| Mental Disorders |