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Cognitive-Behavioral Therapy for Chronic Insomnia After Breast Cancer Treatment (REST)

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ClinicalTrials.gov Identifier: NCT00672217
Recruitment Status : Completed
First Posted : May 6, 2008
Last Update Posted : May 27, 2015
Sponsor:
Collaborators:
National Institute of Nursing Research (NINR)
Denver Health Medical Center
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Cognitive Behavioral Therapy for Insomnia (CBTI) Behavioral: Behavioral Placebo Treatment Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Cognitive-Behavioral Therapy for Chronic Insomnia After Breast Cancer Treatment
Study Start Date : July 2008
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. sleep efficiency [ Time Frame: baseline, pre and post intervention, 3-months, 6-months ]

Secondary Outcome Measures :
  1. sleep latency, total sleep time, quality of life, fatigue [ Time Frame: baseline, pre and post intervention, 3-months, 6-months ]


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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00672217


Locations
United States, Colorado
University of Colorado, College of Nursing
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
National Institute of Nursing Research (NINR)
Denver Health Medical Center
Investigators
Principal Investigator: Ellyn E Matthews, PhD,RN,AOCN University of Colorado, Denver College of Nursing

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00672217     History of Changes
Other Study ID Numbers: 07-0924
5K23NR010587 ( U.S. NIH Grant/Contract )
First Posted: May 6, 2008    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: January 2013

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 Wake Disorders
Nervous System Diseases
Mental Disorders