Self-help Treatment for Insomnia in Breast Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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Self-help Treatment for Insomnia in Breast Cancer Patients

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: professionally administered cognitive-behavioral therapy
* Behavioral: self-administered form of cognitive-behavioral therapy
* Behavioral: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be receiving treatment for a diagnosis of breast or gynaecological cancer To obtain a score of 8 or higher on the Insomnia Severity Index (ISI) or to be using a hypnotic medication ≥ 1 night per week Exclusion Criteria: To have received a diagnosis or being treated for : a sleep disorder other than insomnia (e.g., sleep apnea) a severe psychiatric disorder (e.g., psychotic disorder) a severe cognitive disorder (e.g., dementia)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>professionally administered cognitive-behavioral therapy | Behavioral: professionally administered cognitive-behavioral therapy<br>* professionally administered CBT-I consisting of six weekly sessions<br>|
| Experimental: 2<br>self-administered form of cognitive behavioral therapy | Behavioral: self-administered form of cognitive-behavioral therapy<br>* self-administered CBT-I consisting of six short booklets and videotapes<br>|
| Placebo Comparator: 3<br>usual care | Behavioral: placebo<br>* usual care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep diary indices, actigraphy, Insomnia Severity Index |  | pre-treatment, post-treatment, 3 follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EORTC QLQ, MFI, CFQ, TCEIQ, HADS, DBAS, UHCSQ, costs |  | pre-treatement, post-treatment, 3 follow-up |