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Sponsors and Collaborators: |
Mercy Medical Center Susan G. Komen Breast Cancer Foundation |
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Information provided by: | Mercy Medical Center |
ClinicalTrials.gov Identifier: | NCT00273208 |
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 |
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Fatigue After Adjuvant Breast Cancer Treatment |
Behavioral: 10 week behavioral intervention program |
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 |
Estimated Enrollment: | 25 |
Study Start Date: | September 2005 |
Study Completion Date: | April 2007 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
moderate to severe fatigue >6 months after last chemotherapy or radiation treatment >5 years from diagnosis
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Exclusion Criteria:
Metastatic disease-
United States, Maryland | |
Mercy Medical Center | |
Baltimore, Maryland, United States, 21202 |
Principal Investigator: | Kathy J Helzlsouer, M.D., M.H.S. | Mercy Medical Center |
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 |
breast cancer fatigue |
Signs and Symptoms Fatigue Skin Diseases |
Breast Neoplasms Healthy Breast Diseases |
Neoplasms Neoplasms by Site |