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
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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 |

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 |

- change in fatigue score

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
moderate to severe fatigue >6 months after last chemotherapy or radiation treatment >5 years from diagnosis
Exclusion Criteria:
Metastatic disease-

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
United States, Maryland | |
Mercy Medical Center | |
Baltimore, Maryland, United States, 21202 |
Principal Investigator: | Kathy J Helzlsouer, M.D., M.H.S. | Mercy Medical Center |
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 |