Exercising Our ABC's (African- American Breast Cancer Survivors)
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|ClinicalTrials.gov Identifier: NCT01684579|
Recruitment Status : Completed
First Posted : September 13, 2012
Last Update Posted : March 20, 2013
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: Resistance Exercise Behavioral: Aerobic Exercise Behavioral: Behavioral Group Counseling||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Exercising Our ABC's (African- American Breast Cancer Survivors)|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||March 2013|
Experimental: Exercise and psychosocial counseling
Patients will participate in a psychosocial counseling session, 1 day/week for 20 weeks. Patients will be invited to participate in a progressive aerobic and resistance exercise program designed to achieve moderate and then vigorous levels of exercise, 5 days/week for 20 weeks.
Behavioral: Resistance Exercise
Resistance exercise will be performed 2 days per week for 18 weeks. The resistance training protocol will follow the Resistance Training Strategies for Individuals With Cancer (RTSFIC). The goals will be to keep intensity levels low at the outset (having lighter weights and more reps) and progress slowly and safely. Training prescriptions will be modified based on the training level of the patients and their progress.
Behavioral: Aerobic Exercise
A 20-week aerobic walking exercise program will be developed for each participant based on results of initial exercise testing and prescribed to be done 5 or more days per week designed to progress from moderate exercise intensity, (50-70% maximum heart rate), to vigorous exercise intensity (75-85% maximum heart rate). Maximum heart rate (HR max) will be determined as the peak heart rate achieved during initial cardiopulmonary exercise screening. Heart rate during exercise will be monitored by participants using wrist monitors, already available through TREC Program. Patient progress will also be evaluated using a six minute walk test (6MWT), which will be conducted at TGP at baseline, 6, 12 and 18 weeks and, after completion of the intervention.
Behavioral: Behavioral Group Counseling
The psychosocial component of the 20-week exercise program includes a 1 ½ hour support group offered prior to one of the weekly exercise classes.
- Identify factors contributing to or limiting the success of development of the community-academic partnership. [ Time Frame: 30 weeks ]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.
- Number of African-American women that participate, comply, adhere and sustain an aerobic and resistance exercise program. [ Time Frame: 30 weeks ]A secondary endpoint is to determine if African-American women at the completion of initial therapy for stage I-III breast cancer can be engaged to participate, comply, adhere and sustain an aerobic and resistance exercise program accompanied by psychosocial counseling to improve physical and psychological quality of life.
- Change in circulating levels of known cancer promoting cytokines, adipokines and hormones and other measurements of fitness and well-being. [ Time Frame: 30 weeks ]Ascertain if a graded program to increase aerobic and resistance exercise activities along with psychosocial counseling can be used in African-American women at the completion of initial therapy for breast cancer to improve circulating levels of known cancer promoting cytokines, adipokines and hormones and other measurements of fitness and well-being.
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): NCT01684579
|United States, Ohio|
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Nathan Berger, MD||Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|