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An Intervention to Decrease Fatigue Among Breast Cancer Survivors

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ClinicalTrials.gov Identifier: NCT00273208
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : August 2, 2007
Sponsor:
Collaborator:
Susan G. Komen Breast Cancer Foundation
Information provided by:
Mercy Medical Center

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Fatigue After Adjuvant Breast Cancer Treatment Behavioral: 10 week behavioral intervention program Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Being Well, Staying Healthy: An Integrated Mind-Body Medicine Intervention to Decrease Fatigue Among Breast Cancer Survivors, PILOT STUDY
Study Start Date : September 2005
Actual Study Completion Date : April 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. change in fatigue score

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00273208     History of Changes
Other Study ID Numbers: MMC 2005-01
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: August 2, 2007
Last Verified: August 2007

Keywords provided by Mercy Medical Center:
breast cancer
fatigue

Additional relevant MeSH terms:
Breast Neoplasms
Fatigue
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Signs and Symptoms