Breast Cancer Clinical Trial
Official title:
Fatigue in Breast Cancer:A Behavioral Sleep Intervention
Verified date | August 2023 |
Source | University of Nebraska |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 220 |
Est. completion date | June 1, 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Nebraska Medical Center | Omaha | Nebraska |
Lead Sponsor | Collaborator |
---|---|
University of Nebraska | National Institute of Nursing Research (NINR) |
United States,
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fatigue | Fatigue as measured by Piper Fatigue Scale | 1 year | |
Secondary | Activity-rest as measured by SF-36v2 and actigraphy | Activity-rest as measured by SF-36v2 and actigraphy | 1 year | |
Secondary | Sleep-wake | Sleep-wake as measured by Pittsburgh Sleep Quality Index and actigraphy | 1 year | |
Secondary | Psychological mood | Psychological mood as measured by Hospital Anxiety and Depression Scale | 1 year | |
Secondary | Symptom experience | Symptom experience as measured by Symptom Experience Scale | 1 year |
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