Fatigue
Conditions
Keywords
Cancer, Acupuncture
Brief summary
Based on the investigators clinical experience in patients with chronic disease (Hui, Hui, and Johnston, 2006; Hays et al 2005), a review of the literature (Johnston, Xiao and Hui 2007), and inspired by Vickers and colleagues (PMID: 15117996), the investigators carry out a pilot study that investigates if acupuncture combined with patient education will relieve fatigue in patients who have completed primary treatment for breast cancer.
Detailed description
Patients will be randomly assigned to one of the two groups. Our hypothesis is that patients in the acupuncture/education group will experience greater relief of fatigue than those in the standard care group.
Interventions
PROCEDUREAcupuncture and patient education
Acupuncture involves the insertion of extremely thin needles, much thinner than those used for drawing blood, into very specific acupuncture points. Patients will receive a total of 8 acupuncture treatments, each lasting 50 minutes. Patient education will be delivered to individuals over the course of approximately 50 minutes for each of the four sessions; topics will include acupressure, nutrition, exercise, stress management, and lifestyle advice.
Sponsors
Susan G. Komen Breast Cancer Foundation
Jonsson Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patient is between 18 and 65 years of age 2. Patient has a rounded Brief Fatigue Inventory score of 4 or greater 3. Patient is in a stable clinical condition
Exclusion criteria
1. Severe anemia (hemoglobin level less than 9 g/dL, hematocrit level less than 30, decline in hemoglobin of 2 g/dL in the previous month, or active treatment for anemia) 2. Karnofsky Performance Status below 70 3. Acupuncture treatment in the previous 6 months 4. Fatigue before cancer diagnosis 5. Patient is mentally incapacitated or unfit to provide informed consent or participate in an interview 6. Patient has the potential for serious bleeding due to inherited diseases such as hemophilia 7. Patient is taking medications that are either fatigue-inducing or have sedating properties 8. Patient is unavailable by telephone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue as measured by the Brief Fatigue Inventory | prior to beginning of treatment and after treatment ends. Up to an average of 44 weeks. |
Secondary
| Measure | Time frame |
|---|---|
| Health-Related Quality of Life (HRQoL) as measured by the SF36 | prior to beginning of treatment and after end of treatment. Up to an average of 44 weeks. |
| Pain as measured by an analog scale | prior to beginning of treatment and after conclusion of treatment. Up to an average of 44 weeks. |
| Cognitive complaints as measured by the FACT-COG | prior to the beginning of treatment and after end of treatment. Up to an average of 44 weeks. |
Countries
United States
Outcome results
None listed