Status:
COMPLETED
Cognitive-Behavioral Therapy for Chronic Insomnia After Breast Cancer Treatment
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Denver Health Medical Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
21-65 years
Phase:
NA
Brief Summary
The primary goal of the proposed study is to examine a cognitive behavioral intervention for insomnia (CBTI) in women after breast cancer treatment. Chronic Insomnia is a highly prevalent and distress...
Detailed Description
The overall goals of this study are to: 1) test standard 4-component CBTI in patients with breast cancer post-treatment, 2) gather data on the feasibility of the methods, and 3) determine effects of t...
Eligibility Criteria
Inclusion
- 21 to 65 years of age inclusive
- 1-36 months after radiation or chemotherapy for non-metastatic breast cancer and on a stable dose of anti-estrogen agent and medications for hot flashes
- Meets diagnostic criteria for chronic, secondary insomnia
- Speak and write English
Exclusion
- Presence of a serious unstable physical illness other than cancer
- Presence of dementia, major depression, psychosis or other serious psychiatric disorder
- Presence of a sleep disorder other than insomnia
- Unstable doses of psychotropic medications (excluding hypnotics), opioids, anit-endocrine medications, or use of high dose steroids
- Current evening/night shift employment
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00672217
Start Date
July 1 2008
End Date
May 1 2013
Last Update
May 27 2015
Active Locations (1)
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1
University of Colorado, College of Nursing
Aurora, Colorado, United States, 80045