Improving Fatigue: A Pilot Study of Acupuncture and Patient Education for Breast Cancer Survivors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Fatigue: A Pilot Study of Acupuncture and Patient Education for Breast Cancer Survivors

Conditions
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Fatigue

Intervention / Treatment
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* Procedure: Acupuncture and patient education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is between 18 and 65 years of age Patient has a rounded Brief Fatigue Inventory score of 4 or greater Patient is in a stable clinical condition Exclusion Criteria: 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) Karnofsky Performance Status below 70 Acupuncture treatment in the previous 6 months Fatigue before cancer diagnosis Patient is mentally incapacitated or unfit to provide informed consent or participate in an interview Patient has the potential for serious bleeding due to inherited diseases such as hemophilia Patient is taking medications that are either fatigue-inducing or have sedating properties Patient is unavailable by telephone

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acupuncture & educ<br>Patients will receive a total of 8 acupuncture treatments. In each of the first four sessions, they will also receive patient education. | Procedure: Acupuncture and patient education<br>* 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.<br>* Other names: Traditional Chinese Medicine, Integrative East-West Medicine;|
| No Intervention: 2. Standard care<br>Patients in the control arm will continue to receive standard care from their physician. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Acupuncture