Cognitive-Behavioral Therapy for Chronic Insomnia After Breast Cancer Treatment
REST
2 other identifiers
interventional
64
1 country
1
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 distressing symptom in cancer patients. CBTI is considered the treatment of choice for chronic primary insomnia. Few studies have been conducted in cancer survivors to evaluate the effect of CBTI on sleep and clinically relevant outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started Jul 2008
Typical duration for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2008
CompletedFirst Posted
Study publicly available on registry
May 6, 2008
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedMay 27, 2015
January 1, 2013
4.8 years
May 2, 2008
May 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
sleep efficiency
baseline, pre and post intervention, 3-months, 6-months
Secondary Outcomes (1)
sleep latency, total sleep time, quality of life, fatigue
baseline, pre and post intervention, 3-months, 6-months
Study Arms (2)
Behavioral Placebo Therapy
PLACEBO COMPARATORBehavioral Placebo Treatment
Cognitive Behavioral Therapy
ACTIVE COMPARATORCognitive Behavioral Therapy for Insomnia (CBTI)
Interventions
Six 15-30 minute in-person or phone sessions that incorporate cognitive, behavioral and psycho-educational techniques focused on modifying the perpetuating factors that maintain insomnia.
Six 15-30 minute in-person or phone sessions that begin with a review of the sleep diary, a general discussion of treatment progress and tabulation of sleep parameters.
Eligibility Criteria
You may qualify if:
- to 65 years of age inclusive
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- National Institute of Nursing Research (NINR)collaborator
- Denver Health Medical Centercollaborator
Study Sites (1)
University of Colorado, College of Nursing
Aurora, Colorado, 80045, United States
Related Publications (1)
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.
PMID: 41170811DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ellyn E Matthews, PhD,RN,AOCN
University of Colorado, Denver College of Nursing
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2008
First Posted
May 6, 2008
Study Start
July 1, 2008
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
May 27, 2015
Record last verified: 2013-01