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


Phase 0
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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 TNF╬▒; 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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Identify factors contributing to or limiting the success of development of the community-academic partnership.

Outcome Description:

The primary endpoint is to determine if a successful partnership can be established between a community program, The Gathering Place, committed to providing support services to all community individuals with all types of cancer and academic researchers and clinicians at CWRU, Cleveland Clinic, UHCMC focused on modifying factors associated with energy balance to improve physical and psychological quality of life in cancer patients and provide the basis for future studies and programs to improve prognosis and survival.

Outcome Time Frame:

30 weeks

Safety Issue:

No

Principal Investigator

Nathan Berger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CASE2111

NCT ID:

NCT01684579

Start Date:

June 2011

Completion Date:

March 2013

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • African-American Women
  • Aerobic Exercise
  • Breast Neoplasms

Name

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Cleveland, Ohio  44195