Cognitive-Behavioral Therapy for Chronic Insomnia After Breast Cancer Treatment

NCT ID: NCT00672217

Last Updated: 2015-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2013-05-31

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Behavioral Placebo Therapy

Behavioral Placebo Treatment

Group Type: PLACEBO_COMPARATOR

Behavioral Placebo Treatment

Intervention Type: BEHAVIORAL

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.

Cognitive Behavioral Therapy

Cognitive Behavioral Therapy for Insomnia (CBTI)

Group Type: ACTIVE_COMPARATOR

Cognitive Behavioral Therapy for Insomnia (CBTI)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Denver Health Medical Center

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ellyn E Matthews, PhD,RN,AOCN

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver College of Nursing

Locations

University of Colorado, College of Nursing

Aurora, Colorado, United States

Countries

United States

Other Identifiers

5K23NR010587

Identifier Type: NIH

Identifier Source: secondary_id

View Link

07-0924

Identifier Type: -

Identifier Source: org_study_id