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| Name | Class |
|---|---|
| Canadian Breast Cancer Research Alliance | OTHER |
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The main goal of this population-based study is to assess the efficacy of two forms of cognitive-behavioral therapy (CBT) to treat various levels of insomnia symptoms in women with breast cancer: a professionally administered form and a patient self-administered form. It is hypothesized that the two treatment conditions will be associated with significantly greater improvements in sleep, psychological distress, fatigue, cognitive functioning, and quality of life, relative to the control condition (i.e., usual care). It is also hypothesized that the magnitude of effect sizes obtained in association with treatment at each time assessment will be greater for the professionally administered treatment than the self-administered treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | professionally administered cognitive-behavioral therapy |
|
| 2 | Experimental | self-administered form of cognitive behavioral therapy |
|
| 3 | Placebo Comparator | usual care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| professionally administered cognitive-behavioral therapy | Behavioral | professionally administered CBT-I consisting of six weekly sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| sleep diary indices, actigraphy, Insomnia Severity Index | pre-treatment, post-treatment, 3 follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| EORTC QLQ, MFI, CFQ, TCEIQ, HADS, DBAS, UHCSQ, costs | pre-treatement, post-treatment, 3 follow-up |
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Inclusion Criteria:
Exclusion Criteria:
To have received a diagnosis or being treated for :
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| Name | Affiliation | Role |
|---|---|---|
| Josée Savard, Ph.D. | Centre de recherche de l'HDQ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de recherche de l'HDQ | Québec | Quebec | G1R 2J6 | 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. | |
| 26715229 | Derived | Savard J, Ivers H, Savard MH, Morin CM. Long-Term Effects of Two Formats of Cognitive Behavioral Therapy for Insomnia Comorbid with Breast Cancer. Sleep. 2016 Apr 1;39(4):813-23. doi: 10.5665/sleep.5634. |
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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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| self-administered form of cognitive-behavioral therapy | Behavioral | self-administered CBT-I consisting of six short booklets and videotapes |
|
| placebo | Behavioral | usual care |
|
| 25083010 | Derived | Savard J, Ivers H, Savard MH, Morin CM. Is a video-based cognitive behavioral therapy for insomnia as efficacious as a professionally administered treatment in breast cancer? Results of a randomized controlled trial. Sleep. 2014 Aug 1;37(8):1305-14. doi: 10.5665/sleep.3918. |
| D001523 |
| Mental Disorders |