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An Intervention to Decrease Fatigue Among Breast Cancer Survivors
This study has been completed.
Sponsors and Collaborators: Mercy Medical Center
Susan G. Komen Breast Cancer Foundation
Information provided by: Mercy Medical Center
ClinicalTrials.gov Identifier: NCT00273208
  Purpose

This research project is being done to design and then test whether a 10 week program can help reduce the symptoms of being tired and fatigued among women who have had breast cancer. The pilot study will include 4 groups of women, two groups of women from Baltimore and two groups of women from Washington County, Maryland. Each group will have 5 to 6 women. The purpose of this pilot study is to help us find the best things to include in the program to help women who have had breast cancer and who have severe problems with fatigue that has lasted months to years after being treated with chemotherapy or radiation therapy.

Following the pilot program we will conduct and evaluate (using a quasi-experimental design comparing fatigue scores before and after the intervention) the efficacy of the refined 10-week integrated mind/body medicine approach to reduce symptoms of fatigue among breast cancer survivors who have completed their adjuvant therapy. Four intervention groups (~12 women per group) will be conducted: two in the urban setting and two in the rural setting. We will assess fatigue symptoms at baseline, immediately after the program, 2 months and 6 months following completion of the program. We will compare mean baseline scores to post-intervention scores.

The ultimate goal is to develop a non-pharmacologic, holistic, low risk intervention for improving symptoms of fatigue and thus improving quality of life among breast cancer survivors


Condition Intervention
Fatigue After Adjuvant Breast Cancer Treatment
Behavioral: 10 week behavioral intervention program

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Being Well, Staying Healthy: An Integrated Mind-Body Medicine Intervention to Decrease Fatigue Among Breast Cancer Survivors, PILOT STUDY

Further study details as provided by Mercy Medical Center:

Primary Outcome Measures:
  • change in fatigue score

Estimated Enrollment: 25
Study Start Date: September 2005
Study Completion Date: April 2007
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

moderate to severe fatigue >6 months after last chemotherapy or radiation treatment >5 years from diagnosis

-

Exclusion Criteria:

Metastatic disease-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00273208

Locations
United States, Maryland
Mercy Medical Center
Baltimore, Maryland, United States, 21202
Sponsors and Collaborators
Mercy Medical Center
Susan G. Komen Breast Cancer Foundation
Investigators
Principal Investigator: Kathy J Helzlsouer, M.D., M.H.S. Mercy Medical Center
  More Information

Study ID Numbers: MMC 2005-01
Study First Received: January 5, 2006
Last Updated: August 1, 2007
ClinicalTrials.gov Identifier: NCT00273208  
Health Authority: United States: Institutional Review Board

Keywords provided by Mercy Medical Center:
breast cancer
fatigue

Study placed in the following topic categories:
Signs and Symptoms
Fatigue
Skin Diseases
Breast Neoplasms
Healthy
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009