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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2008 by University of California, Los Angeles.
Recruitment status was Recruiting

Sponsor:

Collaborator:

Susan G. Komen Breast Cancer Foundation

Information provided by:

University of California, Los Angeles

ClinicalTrials.gov Identifier:

NCT00646633

First received: March 25, 2008

Last updated: NA

Last verified: March 2008

History: No changes posted

Tracking Information

First Received Date ^ICMJE

March 25, 2008

Last Updated Date

March 25, 2008

Start Date ^ICMJE

March 2008

Estimated Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Fatigue as measured by the Brief Fatigue Inventory [ Time Frame: prior to beginning of treatment and after treatment ends ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care

Condition ^ICMJE

Fatigue

Intervention ^ICMJE

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

Study Arm (s)

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.

Intervention: Procedure: Acupuncture and patient education
No Intervention: 2. Standard care
Patients in the control arm will continue to receive standard care from their physician.

Publications *

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. Review.
Hays 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.
Johnston, Xiao B, Hui, KK. Acupuncture and fatigue: Current basis for shared communication between breast cancer survivors and providers. Journal of Cancer Survivorship 1(4), 306-12, 2007.
Vickers 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.
Johnston 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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2009

Estimated Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ka-Kit Hui, M.D.	(310) 794-0712	khui@mednet.ucla.edu
Contact: Sue Fan, M.A.	(310) 794-0712	suewfan@yahoo.com

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00646633

Other Study ID Numbers ^ICMJE

06-08-010

Has Data Monitoring Committee

Yes

Responsible Party

Ka-Kit Hui / Professor of Medicine, University of California, Los Angeles

Study Sponsor ^ICMJE

University of California, Los Angeles

Collaborators ^ICMJE

Susan G. Komen Breast Cancer Foundation

Investigators ^ICMJE

Principal Investigator:

Ka-Kit Hui, M.D.

UCLA Center for East-West Medicine, 1033 Gayley Ave, Suite 111, Los Angeles, CA 90024

Information Provided By

University of California, Los Angeles

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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