Physical Activity Intervention to Reduce Functional Health Disparities Among Breast Cancer Survivors
NCT ID: NCT02763228
Last Updated: 2022-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
218 participants
INTERVENTIONAL
2016-03-16
2020-11-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Lifestyle Intervention for High Risk Cancer Survivors
NCT01508273
Exercise in Improving Health and Quality of Life in Breast Cancer Survivors
NCT03679559
Attitudes, Beliefs, and Preferences of Older Stage I-III Breast Cancer Survivors Towards Physical Activity
NCT02566408
The INFLUENCE of PHYSICAL ACTIVITY on the HEALTH and WELL-BEING of BREAST CANCER SURVIVORS
NCT06672380
Feasibility of High Levels of Energy Expenditure From Physical Activity for Breast Cancer Survivors
NCT02963740
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Specific Aim #2: To examine whether race and socioeconomic status (SES) moderate the intervention effect on physical activity (PA) levels and functional outcomes at 20 and 52 weeks.
Specific Aim #3: To examine the effect of the PA intervention on longitudinal changes in beliefs, attitudes and preferences (KAPs) and PA levels, and the extent to which changes in these factors mediate intervention effect on functional outcomes.
Specific Aim #4: To determine the effect of the PA intervention on surrogate biomarkers associated with breast cancer prognosis and functional disability.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1: Exercise Program
The exercise in this study will consist of two types of exercise training: resistance training and aerobic exercise. Resistance training is like "weight lifting" to improve strength and function. Participants will complete resistance training by using resistance machines and free weights. Aerobic exercise is exercise that intends to improve the cardiopulmonary or oxygen/lung and heart systems. It is often referred to as "cardio" exercise. Treadmill walking, stationary cycling sessions, and/or other exercises will be used for aerobic exercise.
Participants will be instructed in the exercise routine by physical fitness experts and trainers.
Aerobic Training - Fixed Schedule
Supervised aerobic training for 40 minutes 3x/week for 20 weeks
Resistance Training - Fixed Schedule
Supervised resistance training for 20 minutes 3x/week for 20 weeks
Walking program
Unsupervised walking program 1-3 days/week for 52 weeks
Aerobic Training - Flexible Schedule
Supervised aerobic training done on the participant's own schedule for 32 weeks
Resistance Training - Flexible Schedule
Supervised resistance training done on the participant's own schedule for 32 weeks
Group 2: Support Group
First 20 Weeks: Participants will take part in a structured Health Education and Support Group sessions once a week.
Last 32 weeks: Participants will be encouraged to take part in any of the Support Group sessions offered regularly on their own schedule.
Successful Survivorship Health Education and Support Group
Support groups will be held for one hour 3x/week for 20 weeks. Topics will include, but are not limited, to long-term side effects of treatment, stress management, coping with fear and uncertainty, body image, sexuality, and spirituality.
Flexible support groups
Participants will attend 1-3 weekly group sessions of their choosing for 32 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Aerobic Training - Fixed Schedule
Supervised aerobic training for 40 minutes 3x/week for 20 weeks
Resistance Training - Fixed Schedule
Supervised resistance training for 20 minutes 3x/week for 20 weeks
Walking program
Unsupervised walking program 1-3 days/week for 52 weeks
Aerobic Training - Flexible Schedule
Supervised aerobic training done on the participant's own schedule for 32 weeks
Resistance Training - Flexible Schedule
Supervised resistance training done on the participant's own schedule for 32 weeks
Successful Survivorship Health Education and Support Group
Support groups will be held for one hour 3x/week for 20 weeks. Topics will include, but are not limited, to long-term side effects of treatment, stress management, coping with fear and uncertainty, body image, sexuality, and spirituality.
Flexible support groups
Participants will attend 1-3 weekly group sessions of their choosing for 32 weeks.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Stage I-III
* Patients who have completed treatment but are within five years of treatment completion (primary surgery, chemotherapy or radiation therapy), whichever was received last. Hormonal therapy and targeted therapy are allowed
* Race: African-Americans and Non-Hispanic Whites
Exclusion Criteria
* Patients with end-stage disease, severe dementia and/or life expectancy of less than one year
* Inability to understand English as study instruments have not been validated in other languages
* Inability to provide informed consent
* High-risk patients (as defined by the American College of Sports Medicine risk-stratification schema using the American College of Sports Medicine (ACSM)/American Heart Association exercise pre-participation questionnaire) who do not receive clearance from cardiology
* Other medical or psychological conditions that would make participation unsafe or inhibit our ability to test our primary hypothesis, e.g. Parkinson's disease, severe dementia.
65 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institutes of Health (NIH)
NIH
Case Comprehensive Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Cynthia Owusu, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Metro Health Medical Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Owusu C, Margevicius S, Nock NL, Austin K, Bennet E, Cerne S, Hergenroeder P, Moore HCF, Petkac J, Schluchter M, Schmitz KH, Webb Hooper M, Wimbley L, Berger NA. A randomized controlled trial of the effect of supervised exercise on functional outcomes in older African American and non-Hispanic White breast cancer survivors: Are there racial differences in the effects of exercise on functional outcomes? Cancer. 2022 Jun 15;128(12):2320-2338. doi: 10.1002/cncr.34184. Epub 2022 Mar 15.
Owusu C, Nock NL, Feuntes V, Margevicius S, Hergenroeder P, Austin K, Bennet E, Cerne S, Moore HCF, Petkac J, Schluchter M, Schmitz KH, Webb Hooper M, Coccia S, Nagy C, Wimbley L, Berger NA. IMPROVE, a community-based exercise intervention versus support group to improve functional and health outcomes among older African American and Non-Hispanic White breast cancer survivors from diverse socioeconomic backgrounds: Recruitment strategies and baseline characteristics. Cancer. 2021 Jun 1;127(11):1836-1846. doi: 10.1002/cncr.33430. Epub 2021 Feb 4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CASE2116
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.