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

Primary Purpose

Fatigue

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Acupuncture and patient education

About this trial

This is an interventional supportive care trial for Fatigue focused on measuring Cancer, Acupuncture

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UCLA Center for East-West Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Acupuncture & educ

2. Standard care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Fatigue as measured by the Brief Fatigue Inventory

Secondary Outcome Measures

Health-Related Quality of Life (HRQoL) as measured by the SF36

Pain as measured by an analog scale

Cognitive complaints as measured by the FACT-COG

Full Information

NCT ID

NCT00646633

First Posted

March 25, 2008

Last Updated

July 5, 2016

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

Susan G. Komen Breast Cancer Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00646633

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2008

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

Susan G. Komen Breast Cancer Foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fatigue

Keywords

Cancer, Acupuncture

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acupuncture & educ

Arm Type

Active Comparator

Arm Description

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

Arm Title

2. Standard care

Arm Type

No Intervention

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Acupuncture and patient education

Other Intervention Name(s)

Traditional Chinese Medicine, Integrative East-West Medicine

Intervention Description

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.

Primary Outcome Measure Information:

Title

Fatigue as measured by the Brief Fatigue Inventory

Time Frame

prior to beginning of treatment and after treatment ends. Up to an average of 44 weeks.

Secondary Outcome Measure Information:

Title

Health-Related Quality of Life (HRQoL) as measured by the SF36

Time Frame

prior to beginning of treatment and after end of treatment. Up to an average of 44 weeks.

Title

Pain as measured by an analog scale

Time Frame

prior to beginning of treatment and after conclusion of treatment. Up to an average of 44 weeks.

Title

Cognitive complaints as measured by the FACT-COG

Time Frame

prior to the beginning of treatment and after end of treatment. Up to an average of 44 weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ka-Kit Hui, M.D.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCLA Center for East-West Medicine

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

16484714

Citation

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.

Results Reference

background

PubMed Identifier

15851771

Citation

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. doi: 10.1177/0163278705275339.

Results Reference

background

PubMed Identifier

18648966

Citation

Johnston 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.

Results Reference

background

PubMed Identifier

15117996

Citation

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. doi: 10.1200/JCO.2004.04.102.

Results Reference

background

PubMed Identifier

21703001

Citation

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. doi: 10.1186/1472-6882-11-49.

Results Reference

derived

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

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