Improving Fatigue: A Pilot Study of Acupuncture and Patient Education for Breast Cancer Survivors
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 25, 2008
CompletedFirst Posted
Study publicly available on registry
March 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedJuly 7, 2016
March 1, 2008
10 months
March 25, 2008
July 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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.
Study Arms (2)
Acupuncture & educ
ACTIVE COMPARATORPatients will receive a total of 8 acupuncture treatments. In each of the first four sessions, they will also receive patient education.
2. Standard care
NO INTERVENTIONPatients in the control arm will continue to receive standard care from their physician.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCLA Center for East-West Medicine
Santa Monica, California, 90404, United States
Related Publications (5)
Hui KK, Hui EK, Johnston MF. The potential of a person-centered approach in caring for patients with cancer: a perspective from the UCLA center for East-West medicine. Integr Cancer Ther. 2006 Mar;5(1):56-62. doi: 10.1177/1534735405286109.
PMID: 16484714BACKGROUNDHays RD, Brodsky M, Johnston MF, Spritzer KL, Hui KK. Evaluating the statistical significance of health-related quality-of-life change in individual patients. Eval Health Prof. 2005 Jun;28(2):160-71. doi: 10.1177/0163278705275339.
PMID: 15851771BACKGROUNDJohnston MF, Xiao B, Hui KK. Acupuncture and fatigue: current basis for shared communication between breast cancer survivors and providers. J Cancer Surviv. 2007 Dec;1(4):306-12. doi: 10.1007/s11764-007-0035-9. Epub 2007 Oct 31.
PMID: 18648966BACKGROUNDVickers AJ, Straus DJ, Fearon B, Cassileth BR. Acupuncture for postchemotherapy fatigue: a phase II study. J Clin Oncol. 2004 May 1;22(9):1731-5. doi: 10.1200/JCO.2004.04.102.
PMID: 15117996BACKGROUNDJohnston MF, Hays RD, Subramanian SK, Elashoff RM, Axe EK, Li JJ, Kim I, Vargas RB, Lee J, Yang L, Hui KK. Patient education integrated with acupuncture for relief of cancer-related fatigue randomized controlled feasibility study. BMC Complement Altern Med. 2011 Jun 25;11:49. doi: 10.1186/1472-6882-11-49.
PMID: 21703001DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ka-Kit Hui, M.D.
UCLA Center for East-West Medicine, 1033 Gayley Ave, Suite 111, Los Angeles, CA 90024
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2008
First Posted
March 28, 2008
Study Start
March 1, 2008
Primary Completion
January 1, 2009
Study Completion
October 1, 2009
Last Updated
July 7, 2016
Record last verified: 2008-03