Completed

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

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What is being tested

Resistance Exercise

+ Aerobic Exercise

+ Behavioral Group Counseling

Behavioral
Who is being recruted

Breast Diseases+3

+ Neoplasms

+ Neoplasms by Site

Over 18 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Early Phase 1
Interventional
Study Start: June 2011
See protocol details

Summary

Principal SponsorCase Comprehensive Cancer Center
Last updated: March 20, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2011

Actual date on which the first participant was enrolled.

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.

Principal SponsorCase Comprehensive Cancer Center
Last updated: March 20, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

19 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesBreast Neoplasms

Criteria

7 inclusion criteria required to participate
Age 18 years and older

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

Eligible patients will include African-American women only

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

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8 exclusion criteria prevent from participating
Caucasian (non-African-American) and male breast cancer patients

History of connective tissue disorder that would limit exercise

Inability to provide informed consent

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)

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

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

Cleveland, United StatesOpen Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center in Google Maps

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, United States
Completed2 Study Centers