Cognitive-Behavioral Therapy for Chronic Insomnia After Breast Cancer Treatment
21 Years
65 Years
Female
Breast Cancer
Trial Information
Cognitive-Behavioral Therapy for Chronic Insomnia After Breast Cancer Treatment
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
Outcome Measure:
sleep efficiency
Outcome Time Frame:
baseline, pre and post intervention, 3-months, 6-months
Safety Issue:
No
Principal Investigator
Ellyn E Matthews, PhD,RN,AOCN
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Colorado, Denver College of Nursing
Authority:
United States: Institutional Review Board
Study ID:
07-0924
NCT ID:
NCT00672217
Start Date:
July 2008
Completion Date:
May 2013
Related Keywords:
- Breast Cancer
- Breast cancer survivors, insomnia, quality of life
- Breast Neoplasms
- Sleep Initiation and Maintenance Disorders
Name | Location |
|---|---|
| University of Colorado, College of Nursing | Aurora, Colorado 80045 |
