Breast Cancer Clinical Trial
Official title:
Effects of a Structured Exercise Program on Cancer-Related Fatigue in Women Receiving Radiation Therapy for Breast Cancer
Verified date | January 2020 |
Source | Georgetown University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Radiation therapy (RT) is often used to treat breast cancer. RT combined with breast surgery
is associated with better outcomes in early stage breast cancer compared to surgery alone.
Fatigue is one of the most important side effects of RT because it can decrease patients'
quality of life.
Studies found that physical activity (PA) may help to improve quality of life in cancer
survivors. PA has been reported to lower fatigue, anxiety, and depression. Physical
inactivity over a long period of time may lead to rapid energy and physical function loss.
PA intervention studies in patients undergoing RT have included mostly White patients. There
is no evidence on African American patients undergoing RT. The purpose of this study is to
examine the efficacy of a structured, moderate-intensity, aerobic exercise program in
reducing cancer-related fatigue in African Americans undergoing RT for localized breast
cancer.
Status | Completed |
Enrollment | 27 |
Est. completion date | December 2015 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 74 Years |
Eligibility |
Inclusion Criteria: - -over 18 years old or less than 75 years old. - histologically confirmed carcinoma of the breast - radiation therapy naive - sedentary, as defined as <60 minutes of recreation or work requiring modest PA/week based on the 7 day physical activity recall questionnaire - ambulatory - negative serum pregnancy test and not planning to be pregnant in the next 3 months - ability to understand and the willingness to sign a written informed consent. - have breast cancer stage 0-IIIA - completed neo-adjuvant or adjuvant chemotherapy may be concurrently receiving endocrine or HER2 directed therapy Exclusion Criteria: - age less than 18 years old or more than 75 years - no histological confirmation of breast cancer - prior breast, chest or pelvic radiotherapy - concurrent chemotherapy - distant metastases - physical limitations (e.g., orthopedic, central nervous system) that contraindicate participation in a low to moderate intensity home-based walking program - a positive pregnancy test, currently pregnant or planning to become pregnant in the next three months - identified as the active or maintenance stage of exercise behavior - psychiatric disorder which would render the subject unable to provide informed consent. |
Country | Name | City | State |
---|---|---|---|
United States | Washington Cancer Institute at Washington Hospital Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Georgetown University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduce cancer-related fatigue | Fatigue Cancer-related fatigue will be determined using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) survey instrument. The FACIT-Fatigue is a 13-item subscale developed to identify a finite set of concerns specific to fatigue. The responses to the 13 items on the FACIT fatigue questionnaire are each measured on a 4-point Likert scale. Thus, the total score ranges from 0 to 52. The FACIT-Fatigue scale has been validated in patients with cancer and showed excellent internal consistency and reliability. | 8 weeks | |
Secondary | Increase quality of life | HRQOL Cancer related HRQOL among participants in the study will be measured using the Functional Assessment of Cancer Therapy (FACT) system questionnaires. The Functional Assessment of Cancer Therapy—General (FACT-G) questionnaire is one of the most widely used HRQOL instruments. It measures HRQOL in four different domains (Physical well-being, Functional well-being, Emotional well-being and Social/Family well-being). To this core questionnaire, we will add specific modules specific for breast (FACT-B) cancer. Thus, the FACT B questionnaire contains an additional series of questions specific to FACT-B some specific questions about breast cancer (37). The FACT system has a number of advantages as a method of measuring HRQOL. The questionnaires have been developed to reflect patients' concerns; moreover they are reliable, reproducible and have been validated in numerous studies. Higher scores on the FACT questionnaires reflect higher QOL. |
8 weeks |
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