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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
Specific Aim #1: To determine the effect of a refined and culturally-sensitive physical activity intervention on functional outcomes at 20 and 52 weeks among older Breast Cancer survivors who are within five years of treatment completion for stage I-III Breast Cancer (BCa).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Exercise Program | Experimental | 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. |
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| Group 2: Support Group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic Training - Fixed Schedule | Behavioral | Supervised aerobic training for 40 minutes 3x/week for 20 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in SPPB scores | 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 52 weeks |
| Change in Activities of daily living (ADL) score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia Owusu, MD | University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41495697 | Derived | 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;26(1):181. doi: 10.1186/s12885-025-15425-w. | |
| 35289926 |
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| Resistance Training - Fixed Schedule | Behavioral | Supervised resistance training for 20 minutes 3x/week for 20 weeks |
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| Walking program | Behavioral | Unsupervised walking program 1-3 days/week for 52 weeks |
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| Aerobic Training - Flexible Schedule | Behavioral | Supervised aerobic training done on the participant's own schedule for 32 weeks |
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| Resistance Training - Flexible Schedule | Behavioral | Supervised resistance training done on the participant's own schedule for 32 weeks |
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| Successful Survivorship Health Education and Support Group | Behavioral | 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. |
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| Flexible support groups | Behavioral | Participants will attend 1-3 weekly group sessions of their choosing for 32 weeks. |
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Summary scores for ADL range from 0-14 and higher scores denote higher functional status. |
| baseline to 20 weeks |
| Change in Activities of daily living (ADL) score | Summary scores for ADL range from 0-14 and higher scores denote higher functional status. | baseline to 52 weeks |
| Metro Health Medical Center |
| Cleveland |
| Ohio |
| 44109 |
| United States |
| Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center | Cleveland | Ohio | 44195 | United States |
| 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. |
| 33539554 | Derived | 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. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D012657 | Self-Help Groups |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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