Exercising Our ABC's (African- American Breast Cancer Survivors)



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:June 2011

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Recent studies have shown that some behavioral factors such as physical activity and
exercise may improve quality of life and outcome in patients with breast cancer as well as
decrease body fat, increase lean mass and reduce cancer-promoting hormones. None of these
studies have been performed in African-American women with breast cancer. The medical field
needs to understand how exercise may benefit cancer patients, particularly African
Americans, and how to optimize these benefits to improve the quality of life, prognosis and
survival.


All exercise training will take place at the Gathering Place, Beachwood OH, in the new
Wellness Center that is equipped with state-of-the-art aerobic and resistance training
apparati. All exercise will be performed under the supervision of the Gathering Place
trained and certified staff. The patient group will perform a 20 week aerobic and resistance
exercise training program to evaluate (compared to baseline) changes: in body composition
(fat, lean tissue and bone mass); cytokines including insulin, leptin, adiponectin, IL-6,
and TNFα; oxidative stress including urine isoprostane; cardiorespiratory fitness (VO2max);
upper and lower body strength (assessed using a dynamometer); sleep (assessed using the
Pittsburgh Sleep Quality Index [PSQI]); fatigue and quality of life (Qol) (assessed using
the SF-36, FACIT instruments). Patients will be evaluated before and after a 20 week
intervention and a 10 week post-intervention period. Participants also will be evaluated
for motivation barriers and compliance. These feasibility parameters will provide the basis
and guidance for an NCI grant application to focus on mechanisms and extend our evaluation
to larger cohorts of African-American patients.

Inclusion Criteria:

- Female patients with a histological confirmation of breast cancer.

- Age 18 years and older.

- Stage I-III. Limiting the cohort to stage I-III cancer limits mortality during the
8-month follow-up period and allows completion of follow-up procedures as well as
enhances exercise participation, i.e. no painful bone metastases or danger of
pathologic fracture, etc.

- Eligible patients will include African-American women only.

- Women with recently diagnosed breast cancer who are no more than 12 months after
completion of initial therapies including neoadjuvant therapy, surgery, radiation
and/or chemotherapy and who are not receiving or scheduled to receive further active
cytotoxic therapy other than adjuvant hormonal therapy or targeted therapy. Women
receiving hormonal therapy or targeted will be eligible to participate in these
studies.

- Eligible patients will include those who meet the criteria for exercise safety as
defined in the American Heart Association and the American College of Sports Medicine
exercise pre-participation questionnaire. All Women will require clearance by
cardiologist.

- Eligible patients include the ability to travel to the Gathering Place, Beachwood OH
and participate in the new Wellness Center that is equipped with state-of-the-art
aerobic and resistance training apparati.

Exclusion Criteria:

- Caucasian (non-African-American) and male breast cancer patients.

- Patients who are beyond 12 months after completion of initial therapies for breast
cancer, or continuing to receive active therapy including neoadjuvant therapy,
surgery, radiation and/or chemotherapy.

- Patients with stage IV disease, severe dementia or life-expectancy less than
6-months.

- Patients will be deemed ineligible if they do not fulfill the criteria for exercise
safety as defined in the American Heart Association and the American College of
Sports Medicine exercise pre-participation questionnaire or do not receive clearance
from cardiologist.

- Inability to understand English as the exercise instructors may not be fluent in
foreign languages and several of the instruments used to assessment have not been
translated into other languages.

- Inability to travel to the Gathering Place, Beachwood OH and participate in the new
Wellness Center that is equipped with state-of-the-art aerobic and resistance
training apparati.(Taxi fare to and from The Gathering Place will be provided where
required)

- History of connective tissue disorder that would limit exercise.

- Inability to provide informed consent.
We found this trial at
2
sites
2010 E 90th St
Cleveland, Ohio 44195
(866) 223-8100
Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-2273
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center We all know...
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Cleveland, OH
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