Cognitive-Behavioral Therapy for Chronic Insomnia After Breast Cancer Treatment

Breast Cancer Clinical Trial

— REST  

Official title:

Cognitive-Behavioral Therapy for Chronic Insomnia After Breast Cancer Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00672217
• Other study ID #: 07-0924
• Secondary ID: 5K23NR010587
• Status: Completed
• Phase: N/A
• First received: May 2, 2008
• Last updated: May 26, 2015
• Start date: July 2008
• Est. completion date: May 2013

Study information

• Verified date: January 2013
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Colorado, College of Nursing	Aurora	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	Denver Health Medical Center, National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sleep efficiency		baseline, pre and post intervention, 3-months, 6-months	No
Secondary	sleep latency, total sleep time, quality of life, fatigue		baseline, pre and post intervention, 3-months, 6-months	No