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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NR018215 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Roswell Park Cancer Institute | OTHER |
| National Institute of Nursing Research (NINR) | NIH |
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The purpose is to determine whether brief behavioral treatment is effective for insomnia in cancer survivors.
A randomized controlled clinical trial will be used to test the efficacy of this brief behavioral treatment compared to attention control on sleep, mood, functional, status and quality of life and determine predictors for efficacy of Brief Behavioral Treatment for Insomnia (BBTI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral: Brief behavioral treatment for insomnia | Experimental | Brief behavioral treatment for insomnia includes 45 minute individual intervention with two follow up phone calls. |
|
| Behavioral: Healthy eating control | Active Comparator | Healthy eating control involves a 45 minute individual session with two follow up phone calls. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief behavioral treatment for insomnia | Behavioral | Brief Behavioral Treatment for Insomnia includes content on sleep restriction, stimulus control, and sleep hygiene content with 1 month for primary outcome followed by 3 month 12 month follow-up visits. |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index | One month after the intervention, experimental group mean for Insomnia Severity Index will be compared to control group mean Insomnia Severity Index. The Insomnia Severity Index is a self report brief screening tool with seven items that asks respondents to rate the nature and symptoms of their sleep problems and the degree to which insomnia interferes with daily functioning and overall distress created by sleep problems using a likert type scale Scores between 0-7 have no clinically significant insomnia. Scores between 8-14 have sub threshold insomnia. Scores between 15-21 have moderate clinical insomnia. Scores between 22-28 have severe clinical insomnia. | one month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne S. Dickerson, PhD | University at Buffalo, School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University at Buffalo | Buffalo | New York | 14214 | United States | ||
| Roswell Park Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 39887070 | Derived | Kwon M, Zhu J, Wilding GE, Larkin K, Gehrman PR, Dickerson SS. Health-related quality of life and mental health outcomes among cancer survivors in an insomnia intervention: a randomized controlled trial. Ann Behav Med. 2025 Jan 4;59(1):kaae096. doi: 10.1093/abm/kaae096. |
| Label | URL |
|---|---|
| Dose-response effects of cognitive-behavioral insomnia therapy: a randomized clinical trial. | View source |
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Approached for study- n=402, Excluded- n=266 [not meeting inclusion criteria- n=75, Declined to participate- n=47, No response after initial contact- n=144, Total participants completing screening n=136, however, 4 participants quit prior to randomization.
Final total enrolled participants = 132 with 66 in experimental and 66 in the control group.](streamdown:incomplete-link)
Participants were recruited from a major comprehensive cancer center and ancillary sites in WNY between 6/2019 and 10/2022. The first participant was enrolled 6/6/2019 and last participant was enrolled 9/26/2022. Date of last participant's last visit 11/01/2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral: Brief Behavioral Treatment for Insomnia | Brief behavioral treatment for insomnia includes 45 minute individual intervention with two follow up phone calls. Brief behavioral treatment for insomnia: Brief behavioral Managment of Insomnia content with 1 month 3 month 12 month follow-up visits. |
| FG001 | Behavioral: Healthy Eating Control | Healthy eating control involves a 45 minute individual session with two follow up phone calls. Brief behavioral treatment for insomnia: Healthy eating control involves healthy eating content with 1 month 3 month 12 month follow-up visits. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral: Brief Behavioral Treatment for Insomnia | Brief behavioral treatment for insomnia includes 45 minute individual intervention with two follow up phone calls. Brief behavioral treatment for insomnia: Healthy eating control involves healthy eating content with 1 month 3 month 12 month follow-up visits. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Insomnia Severity Index | One month after the intervention, experimental group mean for Insomnia Severity Index will be compared to control group mean Insomnia Severity Index. The Insomnia Severity Index is a self report brief screening tool with seven items that asks respondents to rate the nature and symptoms of their sleep problems and the degree to which insomnia interferes with daily functioning and overall distress created by sleep problems using a likert type scale Scores between 0-7 have no clinically significant insomnia. Scores between 8-14 have sub threshold insomnia. Scores between 15-21 have moderate clinical insomnia. Scores between 22-28 have severe clinical insomnia. | The main efficacy was determined at one month after the intervention. The study continued with measurements at 3 months and 12 months to determine durability. additional participants dropped out and the final numbers in the study were 60 experimental and 59 control. | Posted | Mean | 95% Confidence Interval | score on a scale | one month |
|
1 month
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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 | Behavioral: Brief Behavioral Treatment for Insomnia | Brief behavioral treatment for insomnia intervention includes 45 minute individual intervention with two follow up phone calls.with 1 month followup for Insomnia Severity Index measure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Suzanne S. Dickerson | School of Nursing, University at Buffalo | 716-829-3254 | sdickers@buffalo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 26, 2023 | Oct 18, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 26, 2023 | Oct 18, 2023 | ICF_001.pdf |
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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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| Healthy Eating Control | Behavioral | Healthy eating control involves healthy eating content with 1 month for primary outcome followed by 3 month and 12 month follow-up visits. |
|
| Buffalo |
| New York |
| 14263 |
| United States |
| 39589721 | Derived | Dickerson SS, Kwon M, Wilding GE, Zhu J. Nurse-delivered brief behavioral treatment for insomnia in cancer survivors: a randomized controlled trial. J Cancer Surviv. 2026 Jun;20(3):1010-1022. doi: 10.1007/s11764-024-01704-1. Epub 2024 Nov 26. |
| 38047967 | Derived | Kwon M, Zhu J, Wilding GE, Dickerson SS, Dean GE. Sleep-wake state discrepancy among cancer survivors with insomnia symptoms. Support Care Cancer. 2023 Dec 4;32(1):2. doi: 10.1007/s00520-023-08177-5. |
| 36182027 | Derived | Kwon M, Dickerson SS, Wilding GE, Aquilina AT, Reid M, Dean GE. A nurse-delivered intervention to reduce insomnia in cancer survivors: Study protocol for a randomized-controlled trial. Contemp Clin Trials. 2022 Nov;122:106939. doi: 10.1016/j.cct.2022.106939. Epub 2022 Sep 28. |
| A primary care "friendly" cognitive behavioral insomnia therapy. | View source |
| Effects of a brief behavioral treatment for PTSD-related sleep disturbances: a pilot study. | View source |
| Randomized controlled clinical effectiveness trial of cognitive behavior therapy compared with treatment as usual for persistent insomnia in patients with cancer. | View source |
| How to provide insomnia interventions to people with cancer: insights from patients. | View source |
| Behavioral: Healthy Eating Control |
Healthy eating control involves a 45 minute individual session with two follow up phone calls. Brief behavioral treatment for insomnia: Healthy eating control involves healthy eating content with 1 month 3 month 12 month follow-up visits. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Insomnia Severity Index | the Insomnia Severity Index is a self report brief screening tool with seven items that asks respondents to rate the nature and symptoms of their sleep problems and the degree to which insomnia interferes with daily functioning and overall distress created by sleep problems using a likert type scale. Scores from 8-14 meaures subthreshhold insomnia, 15-21 measures moderate insomnia, and 22-28 measures severe insomnia. Higher scores reflect worse outcomes. | Mean | Standard Deviation | units on a scale |
|
| Behavioral: Brief Behavioral Treatment for Insomnia |
Brief behavioral treatment for insomnia intervention includes 45 minute individual intervention with two follow up phone calls.with 1 month followup for Insomnia Severity Index measure |
| OG001 | Behavioral: Healthy Eating Control | Healthy eating control involves a 45 minute individual session with two follow up phone calls with one month followup for Insomnia severity Index measure. |
|
|
| 0 |
| 62 |
| 0 |
| 62 |
| 0 |
| 62 |
| EG001 | Behavioral: Healthy Eating Control | Healthy eating control involves a 45 minute individual session with two follow up phone calls with one month followup for Insomnia Severity Index measure. | 0 | 60 | 0 | 60 | 0 | 60 |
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| D001523 |
| Mental Disorders |