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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-10-31

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.

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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.

Conditions

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Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Acupuncture & educ

Patients will receive a total of 8 acupuncture treatments. In each of the first four sessions, they will also receive patient education.

Group Type ACTIVE_COMPARATOR

Acupuncture and patient education

Intervention Type PROCEDURE

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.

2. Standard care

Patients in the control arm will continue to receive standard care from their physician.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acupuncture 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.

Intervention Type PROCEDURE

Other Intervention Names

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Traditional Chinese Medicine, Integrative East-West Medicine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No