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| Name | Class |
|---|---|
| Canadian Cancer Society (CCS) | OTHER |
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Sleep disturbance in cancer patients is often overlooked despite its documented high prevalence and negative impact. There are few empirically validated non-pharmacological treatments for insomnia and many patients are unwilling to rely on sleeping medications. This study will determine whether Mindfulness-Based Stress Reduction (a program that teaches meditation and yoga) produces equivalent results with the additional benefits of reduced stress and mood disturbance, to an already established treatment for insomnia, Cognitive-Behavioral Therapy. This will allow for the expansion of treatment options for insomnia beyond what is currently available and improve quality of life for millions of cancer survivors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavior Therapy | Experimental | Cognitive Behavior Therapy for insomnia consists of stimulus control therapy, sleep restriction therapy, cognitive therapy and relaxation. |
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| Mindfulness-Based Stress Reduction | Experimental | The program consists of three primary components: theoretical material related to relaxation, meditation, and the mind-body connection; experiential practice of meditation and yoga and home based practice; group process focused on problem solving and support. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-Based Stress Reduction | Behavioral | This intervention is provided over the course of eight, weekly, 90 minute sessions, plus one 6 hour silent retreat. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Insomnia Severity from baseline to 3 months | Baseline, Post-Treatment, 3 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in objective measures of sleep using Wrist Actigraphy from baseline to 3 months | Baseline, Post Treatment, 3 month follow up | |
| Change in subjective measures of sleep using Sleep Diaries from baseline to 3 months | Baseline (one week), During treatment (7 weeks), Post Treatment (1 week), 3 month Follow up (1 week) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tavis S Campbell, PhD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tom Baker Cancer Centre-Holy Cross Site | Calgary | Alberta | T2S 3C1 | Canada |
| 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. | |
| 24395850 | Derived | Garland SN, Carlson LE, Stephens AJ, Antle MC, Samuels C, Campbell TS. Mindfulness-based stress reduction compared with cognitive behavioral therapy for the treatment of insomnia comorbid with cancer: a randomized, partially blinded, noninferiority trial. J Clin Oncol. 2014 Feb 10;32(5):449-57. doi: 10.1200/JCO.2012.47.7265. Epub 2014 Jan 6. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| 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 |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| Cognitive Behavior Therapy | Behavioral | This treatment is delivered to small groups over the course of 8 weekly, 90 minute sessions |
|
|
| Change in Pittsburgh Sleep Quality Index scores from baseline to 3 months | Baseline, Post Treatment, 3 month follow up |
| Change in Dysfunctional Attitudes and Beliefs about Sleep Scale scores from baseline to 3 months | Baseline, Post Treatment, 3 month folllow up |
| Change in Calgary Symptoms of Stress Inventory scores from baseline to 3 months | Baseline, Post Treatment, 3 month folllow up |
| Change in Five Facet Mindfulness Questionnaire scores from baseline to 3 months | Baseline, Post Treatment, 3 month folllow up |
| D001523 |
| Mental Disorders |