Cognitive-Behavioral Therapy for Chronic Insomnia After Breast Cancer Treatment (REST)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Behavioral: Cognitive Behavioral Therapy for Insomnia (CBTI) Behavioral: Behavioral Placebo Treatment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Cognitive-Behavioral Therapy for Chronic Insomnia After Breast Cancer Treatment |
- sleep efficiency [ Time Frame: baseline, pre and post intervention, 3-months, 6-months ] [ Designated as safety issue: No ]
- sleep latency, total sleep time, quality of life, fatigue [ Time Frame: baseline, pre and post intervention, 3-months, 6-months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Behavioral Placebo Therapy
Behavioral Placebo Treatment
|
Behavioral: Behavioral Placebo Treatment
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.
|
|
Active Comparator: Cognitive Behavioral Therapy
Cognitive Behavioral Therapy for Insomnia (CBTI)
|
Behavioral: Cognitive Behavioral Therapy for Insomnia (CBTI)
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.
|
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 the intervention on quality of life (QOL) and daily functioning. Sixty women after completion of primary breast cancer treatment, 21-65 years of age, who meet the criteria for chronic insomnia will be recruited from two Western U.S. Cancer Centers. Participants will be randomized to one of two treatment conditions (CBTI or behavioral placebo treatment). Both groups will receive six in-office and phone sessions. The control group will receive the same amount of individualized attention. Sleep efficiency and component measures (e.g., sleep onset latency, minutes awake after sleep onset) and quality of life and component measures of daily functioning will be assess pre and post-intervention, and at 3- and 6-month follow up visits. It is hypothesized that women receiving CBTI treatment will demonstrate greater increase in sleep efficiency (time in bed compared with time asleep) and will self-report greater improvements in QOL and daily functioning compared to those receiving a behavioral placebo treatment at the conclusion of the intervention and at 3- to 6-month follow-ups. Established instruments include the Insomnia Severity Index, Morin Sleep Diary, Dysfunctional Beliefs and Attitudes about Sleep-16, European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30, Attentional Function Index, Revised Piper Fatigue Scale, and Hospital Anxiety and Depression Scale. Subjective data will be corroborated with actigraphy. Results may inform development of clinical guidelines for insomnia management after cancer treatment. The proposed study associated with this K23 award relates to the Health People 2010 goal of improving quality of life of individuals of all ages, and the cancer focus area goal of reducing illness and disability caused by cancer.
Eligibility| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations| Contact: Ellyn E Matthews, PhD,RN,AOCN | 303-724-8552 | ellyn.matthews@ucdenver.edu |
| Contact: Michaela S McCarthy, BSN | 303-724-4972 | michaela.mccarthy@ucdenver.edu |
| United States, Colorado | |
| University of Colorado, College of Nursing | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Ellyn E Matthews, PhD,RN,AOCN 303-724-8552 ellyn.matthews@ucdenver.edu | |
| Principal Investigator: Ellyn E. Matthews, PhD,RN,AOCN | |
| Principal Investigator: | Ellyn E Matthews, PhD,RN,AOCN | University of Colorado, Denver College of Nursing |
More Information
No publications provided
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT00672217 History of Changes |
| Other Study ID Numbers: | 07-0924, 5K23NR010587 |
| Study First Received: | May 2, 2008 |
| Last Updated: | January 23, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Colorado, Denver:
|
Breast cancer survivors, insomnia, quality of life |
Additional relevant MeSH terms:
|
Breast Neoplasms Sleep Initiation and Maintenance Disorders Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Mental Disorders |
ClinicalTrials.gov processed this record on May 21, 2013