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Fatigue in Breast Cancer:A Behavioral Sleep Intervention

Phase 3
19 Years
Not Enrolling
Breast Cancer

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Trial Information

Fatigue in Breast Cancer:A Behavioral Sleep Intervention

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

fatigue as measured by Piper Fatigue Scale

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Ann M Berger, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Nebraska


United States: Institutional Review Board

Study ID:




Start Date:

April 2003

Completion Date:

June 2006

Related Keywords:

  • Breast Cancer
  • fatigue
  • activity-rest
  • sleep-wake
  • psychological distress
  • symptom management
  • Breast Neoplasms
  • Fatigue



University of Nebraska Medical CenterOmaha, Nebraska  68198-3330