Fatigue in Breast Cancer: A Behavioral Sleep Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00572416
Recruitment Status : Completed
First Posted : December 13, 2007
Last Update Posted : December 13, 2007
Information provided by:
University of Nebraska

Brief Summary:
  1. This randomized clinical trial compares a four component behavioral sleep intervention group to an attention control healthy eating group
  2. The behavioral sleep intervention is designed to reduce fatigue in women with stages I-IIIA breast cancer receiving anthracycline-based chemotherapy
  3. The intervention uses an Individual Sleep Promotion Plan to promote daytime activity and nighttime sleep,and to decrease physchological and symptom distress
  4. The healthy eating group receives equal time and attention and information on healthy eating
  5. All participants receive a research nurse visit 2 days prior to each chemotherapy treatment, and 30, 60, 90 days after the last treatment, and one-year after the first treatment.
  6. Adherence to the intervention is calculated at each time
  7. Reliable and valid instruments are used, including wrist actigraphy

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Individual Sleep Promotion Plan Behavioral: Healthy Eating Control Phase 3

Detailed Description:
Higher fatigue levels are found in women with stage I, II or IIIA breast cancer receiving adjuvant chemotherapy (CT) who adopt patterns of daytime inactivity and nighttime restlessness and have more symptom and psychological distress. Interventions that improve sleep quality and reduce daytime fatigue in persons with insomnia may also benefit women receiving adjuvant CT. Using selected factors from Piper's Integrated Fatigue Model (IFM), a randomized, controlled clinical trial will compare women with breast cancer who receive a four component behavioral sleep intervention to women in the attentional control group during and after adjuvant CT. The intervention is designed to reduce fatigue in these women by promoting daytime activity, improving sleep quality and decreasing symptom and psychological distress. The aims of this study are to: 1) Compare the immediate (sleep/wake, activity/exercise, symptoms, psychological distress) and consequent (fatigue) outcomes of women who receive a four component behavioral sleep intervention (sleep hygiene counseling, relaxation therapy, sleep restriction and stimulus control) (n=110) with the outcomes in the healthy eating group (n=110) in women with stage I, II or IIIA breast cancer during 4 or 8 cycles of adjuvant chemotherapy, at 30, 60 and 90 days after their last treatment, and 1 year after their first treatment; 2) Determine the extent to which factors selected from the IFM influence fatigue intensity levels a) in the total sample at baseline and b) differentially influence fatigue intensity levels between groups 30 days after the last chemotherapy treatment and 1 year after the first treatment and 3) Evaluate the adherence to the refined behavioral sleep intervention and preferences for sleep hygiene and relaxation therapy techniques in the experimental group over time. Women will be randomized on the basis of good or poor sleeping history and intent to treat (4 versus 8 cycles of CT) to the intervention or attentional control group. Using the co-scientist model, the sleep intervention group will follow an Individual Sleep Promotion Plan negotiated with the investigator with regularly scheduled reinforcements and revisions. The healthy eating group will receive equal time and attention regarding general topics and nutrition. Established instruments include the Piper Fatigue Scale, Hospital Anxiety and Depression Scale, SF-36 Health Survey, Symptom Experience Scale, Daily Diary and Pittsburgh Sleep Quality Index. Objective measures include wrist actigraph, hemoglobin/ hematocrit, white blood count, T4 & TSH, and body mass index and a C - reactive protein at 1 year. Statistical analyses include RM-ANOVA, generalized estimation equation methodology and multiple regression analysis. Results may inform development of clinical guidelines for fatigue management during adjuvant CT.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Fatigue in Breast Cancer:A Behavioral Sleep Intervention
Study Start Date : April 2003
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Four component behavioral sleep intervention comprised of activity-rest, sleep-wake, phychological distress and symptom management. Four components of the Individual Sleep Promotion Plan are: stimulus control, sleep restruction, relaxation, and sleep hygiene.
Behavioral: Individual Sleep Promotion Plan
Four components, including activity-rest, sleep-wake, psychological distress, and symptom management. Sleep-wake component has four strategies: stimulus control, sleep restriction, relaxation, and sleep hygiene
Placebo Comparator: 2
Equal time and attention, information about healthy eating and general conversation
Behavioral: Healthy Eating Control
Equal time and attention and information about healthy eating

Primary Outcome Measures :
  1. fatigue as measured by Piper Fatigue Scale [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. activity-rest as measured by SF-36v2 and actigraphy [ Time Frame: 1 year ]
  2. sleep-wake as measured by Pittsburgh Sleep Quality Index and actigraphy [ Time Frame: 1 year ]
  3. pyschological mood as measured by Hospital Anxiety and Depression Scale [ Time Frame: 1 year ]
  4. symptom experience as measured by Symptom Experience Scale [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ages 19 and older
  • Diagnosed for the first time with stage I-IIIA breast cancer
  • Post-operative for breast cancer
  • Scheduled to receive anthracycline-based adjuvant chemotherapy with our without taxane chemotherapy
  • English speaking
  • Karnofsky performance Scale score equal to or greater than 60

Exclusion Criteria:

  • Comorbid diagnosis of chronic insomnia
  • Sleep apnea or chronic fatigue syndrome
  • Unstable congestive heart failure
  • Chronic obstructive pulmonary disease
  • Insulin-depenent diabetes
  • Neruomuscular disease
  • Abnormal thryoid function
  • Depression, or
  • Treatment with steriods
  • Erratic sleep schedule due to working rotating shifts

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 identifier (NCT number): NCT00572416

United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-5330
Sponsors and Collaborators
University of Nebraska
Principal Investigator: Ann M Berger, PhD University of Nebraska

Publications of Results:
Responsible Party: Ann M. Berger, PI, University of Nebraska Medical Center Identifier: NCT00572416     History of Changes
Other Study ID Numbers: 140-02FB
5R01NR007762-05 ( U.S. NIH Grant/Contract )
First Posted: December 13, 2007    Key Record Dates
Last Update Posted: December 13, 2007
Last Verified: December 2007

Keywords provided by University of Nebraska:
psychological distress
symptom management

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Signs and Symptoms