Improving Fatigue: A Pilot Study of Acupuncture and Patient Education for Breast Cancer Survivors
Recruitment status was Recruiting
Based on our 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), we 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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Improving Fatigue: A Pilot Study of Acupuncture and Patient Education for Breast Cancer Survivors|
- Fatigue as measured by the Brief Fatigue Inventory [ Time Frame: prior to beginning of treatment and after treatment ends ] [ Designated as safety issue: No ]
- Health-Related Quality of Life (HRQoL) as measured by the SF36 [ Time Frame: prior to beginning of treatment and after end of treatment ] [ Designated as safety issue: No ]
- Pain as measured by an analog scale [ Time Frame: prior to beginning of treatment and after conclusion of treatment ] [ Designated as safety issue: No ]
- Cognitive complaints as measured by the FACT-COG [ Time Frame: prior to the beginning of treatment and after end of treatment ] [ Designated as safety issue: No ]
|Study Start Date:||March 2008|
|Estimated Study Completion Date:||March 2009|
|Estimated Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Active Comparator: Acupuncture & educ
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
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.
Other Name: Traditional Chinese Medicine, Integrative East-West Medicine
No Intervention: 2. Standard care
Patients in the control arm will continue to receive standard care from their physician.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00646633
|Contact: Ka-Kit Hui, M.D.||(310) firstname.lastname@example.org|
|Contact: Sue Fan, M.A.||(310) email@example.com|
|United States, California|
|UCLA Center for East-West Medicine||Recruiting|
|Santa Monica, California, United States, 90404|
|Principal Investigator: Ka-Kit Hui, M.D.|
|Principal Investigator:||Ka-Kit Hui, M.D.||UCLA Center for East-West Medicine, 1033 Gayley Ave, Suite 111, Los Angeles, CA 90024|