Back to resultsSelf-help Treatment for Insomnia in Breast Cancer Patients
Primary Purpose
Insomnia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
professionally administered cognitive-behavioral therapy
self-administered form of cognitive-behavioral therapy
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia
Eligibility Criteria
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)
Sites / Locations
- Centre de recherche de l'HDQ
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
Arm Description
professionally administered cognitive-behavioral therapy
self-administered form of cognitive behavioral therapy
usual care
Outcomes
Primary Outcome Measures
sleep diary indices, actigraphy, Insomnia Severity Index
Secondary Outcome Measures
EORTC QLQ, MFI, CFQ, TCEIQ, HADS, DBAS, UHCSQ, costs
Full Information
NCT ID
NCT00674830
First Posted
May 7, 2008
Last Updated
August 14, 2013
Sponsor
CHU de Quebec-Universite Laval
Collaborators
Canadian Breast Cancer Research Alliance
1. Study Identification
Unique Protocol Identification Number
NCT00674830
Brief Title
Self-help Treatment for Insomnia in Breast Cancer Patients
Official Title
Self-help Treatment for Insomnia in Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Quebec-Universite Laval
Collaborators
Canadian Breast Cancer Research Alliance
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
professionally administered cognitive-behavioral therapy
Arm Title
2
Arm Type
Experimental
Arm Description
self-administered form of cognitive behavioral therapy
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
usual care
Intervention Type
Behavioral
Intervention Name(s)
professionally administered cognitive-behavioral therapy
Intervention Description
professionally administered CBT-I consisting of six weekly sessions
Intervention Type
Behavioral
Intervention Name(s)
self-administered form of cognitive-behavioral therapy
Intervention Description
self-administered CBT-I consisting of six short booklets and videotapes
Intervention Type
Behavioral
Intervention Name(s)
placebo
Intervention Description
usual care
Primary Outcome Measure Information:
Title
sleep diary indices, actigraphy, Insomnia Severity Index
Time Frame
pre-treatment, post-treatment, 3 follow-up
Secondary Outcome Measure Information:
Title
EORTC QLQ, MFI, CFQ, TCEIQ, HADS, DBAS, UHCSQ, costs
Time Frame
pre-treatement, post-treatment, 3 follow-up
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josée Savard, Ph.D.
Organizational Affiliation
Centre de recherche de l'HDQ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de recherche de l'HDQ
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
26715229
Citation
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.
Results Reference
derived
PubMed Identifier
25083010
Citation
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.
Results Reference
derived
Learn more about this trial
Self-help Treatment for Insomnia in Breast Cancer Patients
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