Trial record 18 of 54 for:    Insomnia | Open Studies | NIH, U.S. Fed

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Colorado, Denver
Sponsor:
Collaborators:
Denver Health Medical Center
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00672217
First received: May 2, 2008
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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 Intervention
Breast Cancer
Behavioral: Cognitive Behavioral Therapy for Insomnia (CBTI)
Behavioral: Behavioral Placebo Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Cognitive-Behavioral Therapy for Chronic Insomnia After Breast Cancer Treatment

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • sleep efficiency [ Time Frame: baseline, pre and post intervention, 3-months, 6-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • sleep latency, total sleep time, quality of life, fatigue [ Time Frame: baseline, pre and post intervention, 3-months, 6-months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2008
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00672217

Contacts
Contact: Ellyn E Matthews, PhD,RN,AOCN 303-724-8552 ellyn.matthews@ucdenver.edu
Contact: Michaela S McCarthy, BSN 303-724-4972 michaela.mccarthy@ucdenver.edu

Locations
United States, Colorado
University of Colorado, College of Nursing Recruiting
Aurora, Colorado, United States, 80045
Contact: Ellyn E Matthews, PhD,RN,AOCN    303-724-8552    ellyn.matthews@ucdenver.edu   
Principal Investigator: Ellyn E. Matthews, PhD,RN,AOCN         
Sponsors and Collaborators
University of Colorado, Denver
Denver Health Medical Center
Investigators
Principal Investigator: Ellyn E Matthews, PhD,RN,AOCN University of Colorado, Denver College of Nursing
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00672217     History of Changes
Other Study ID Numbers: 07-0924, 5K23NR010587
Study First Received: May 2, 2008
Last Updated: January 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Breast cancer survivors, insomnia, quality of life

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014