Neoplasms

Skin and Connective Tissue Diseases

All Conditions

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Symptoms and General Pathology

Rare Diseases

Breast Neoplasms

Sleep Initiation and Maintenance Disorders

Breast Diseases

Skin Diseases

Parasomnias

Sleep Disorders, Intrinsic

Dyssomnias

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Mental Disorders

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Quality of Life

Chronic Graft Versus Host Disease

Central Nervous System Depressants

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Tannic Acid

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.

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.

Behavioral Placebo Treatment

Ellyn E Matthews, PhD,RN,AOCN

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.

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.

Cognitive-Behavioral Therapy for Chronic Insomnia After Breast Cancer Treatment

National Institute of Nursing Research (NINR)

Denver Health Medical Center

University of Colorado, Denver

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Cognitive-Behavioral Therapy for Chronic Insomnia After Breast Cancer Treatment	NCT00672217	Breast Cancer	Cognitive Behav... Behavioral Plac...	21 Years - 65 Years	University of Colorado, Denver
Cognitive-Behavioral Therapy for Chronic Insomnia After Breast Cancer Treatment	NCT00672217	Breast Cancer	Cognitive Behav... Behavioral Plac...	21 Years - 65 Years	University of Colorado, Denver

Spots Global Cancer Trial Database for behavioral placebo treatment