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

NCT01684579 | Completed Early Phase 1 DMC

• 1 other identifier: CASE2111
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; African-American Women; Aerobic Exercise

Outcome Measures

Primary Outcomes (1)

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

  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.

  30 weeks

Secondary Outcomes (2)

• Number of African-American women that participate, comply, adhere and sustain an aerobic and resistance exercise program.

  30 weeks

• Change in circulating levels of known cancer promoting cytokines, adipokines and hormones and other measurements of fitness and well-being.

  30 weeks

Study Arms (1)

Exercise and psychosocial counseling

EXPERIMENTAL

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; Behavioral: Aerobic Exercise; Behavioral: Behavioral Group Counseling

Interventions

Resistance Exercise BEHAVIORAL

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.

Exercise and psychosocial counseling

Aerobic Exercise BEHAVIORAL

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.

Exercise and psychosocial counseling

Behavioral Group Counseling BEHAVIORAL

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.

Exercise and psychosocial counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (2)

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

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Resistance Training; Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nathan Berger, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: September 13, 2012
• Study Start: June 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: March 1, 2013
• Last Updated: March 20, 2013

Record last verified: 2013-03

Locations

US (2)