Physical Activity Intervention to Reduce Functional Health Disparities Among Breast Cancer Survivors
A Physical Activity Intervention to Reduce Functional Health Disparities Among Older Breast Cancer Survivors
1 other identifier
interventional
218
1 country
3
Brief Summary
The purpose of this research study is to determine whether a physical activity (exercise) program in the community will improve the functional and overall health status of older women with a history of breast cancer. The physical activity or exercise program is designed for all older breast cancer survivors, and in particular for African-Americans and women of lower socio-economic status, who are the least likely to engage in physical activity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Mar 2016
Typical duration for not_applicable breast-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 16, 2016
CompletedFirst Submitted
Initial submission to the registry
April 27, 2016
CompletedFirst Posted
Study publicly available on registry
May 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2020
CompletedMarch 22, 2022
March 1, 2022
4 years
April 27, 2016
March 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in physical performance scores based on the Short Physical Performance Battery (SPPB)
Change in physical performance will be ascertained using the Short Physical Performance Battery (SPPB). Summary scores range from 0-12 and higher scores denote higher physical performance.
baseline to 20 weeks
Secondary Outcomes (3)
Change in SPPB scores
baseline to 52 weeks
Change in Activities of daily living (ADL) score
baseline to 20 weeks
Change in Activities of daily living (ADL) score
baseline to 52 weeks
Study Arms (2)
Group 1: Exercise Program
EXPERIMENTALThe 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.
Group 2: Support Group
ACTIVE COMPARATORFirst 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.
Interventions
Supervised aerobic training for 40 minutes 3x/week for 20 weeks
Supervised resistance training for 20 minutes 3x/week for 20 weeks
Unsupervised walking program 1-3 days/week for 52 weeks
Supervised aerobic training done on the participant's own schedule for 32 weeks
Supervised resistance training done on the participant's own schedule for 32 weeks
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.
Participants will attend 1-3 weekly group sessions of their choosing for 32 weeks.
Eligibility Criteria
You may qualify if:
- Pathologically confirmed breast cancer
- 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
You may not qualify if:
- Stage IV breast cancer
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106, United States
Metro Health Medical Center
Cleveland, Ohio, 44109, United States
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195, United States
Related Publications (3)
Hundal J, Williams D, Nock NL, Austin K, Bennet E, Cerne S, Moore HCF, Petkac J, Schmitz KH, Berger NA, Owusu C. Older breast cancer survivors' exercise and support group program experiences and recommendations from the IMPROVE trial: a qualitative study. BMC Cancer. 2026 Jan 6. doi: 10.1186/s12885-025-15425-w. Online ahead of print.
PMID: 41495697DERIVEDOwusu 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.
PMID: 35289926DERIVEDOwusu 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.
PMID: 33539554DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cynthia Owusu, MD
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2016
First Posted
May 5, 2016
Study Start
March 16, 2016
Primary Completion
March 25, 2020
Study Completion
November 6, 2020
Last Updated
March 22, 2022
Record last verified: 2022-03