Clinical trial NCT00572416: Fatigue in Breast Cancer: A Behavioral Sleep Intervention
Official title: Fatigue in Breast Cancer:A Behavioral Sleep Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: fatigue
activity-rest
sleep-wake
psychological distress
symptom management
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2007-12-13
Enrollment: 220
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fatigue
timeFrame: 1 year
Secondary outcomes:
measure: Activity-rest as measured by SF-36v2 and actigraphy
timeFrame: 1 year
measure: Sleep-wake
timeFrame: 1 year
measure: Psychological mood
timeFrame: 1 year
measure: Symptom experience
timeFrame: 1 year
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Ann M Berger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berger AM, Farr LA, Kuhn BR, Fischer P, Agrawal S. Values of sleep/wake, activity/rest, circadian rhythms, and fatigue prior to adjuvant breast cancer chemotherapy. J Pain Symptom Manage. 2007 Apr;33(4):398-409. doi: 10.1016/j.jpainsymman.2006.09.022.
citation: Berger AM, Neumark DE, Chamberlain J. Enhancing recruitment and retention in randomized clinical trials of cancer symptom management. Oncol Nurs Forum. 2007 Mar;34(2):E17-22. doi: 10.1188/07.ONF.E17-E22.