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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
218
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
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
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.
Time frame: baseline to 20 weeks
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.
Time frame: baseline to 52 weeks
Change in Activities of daily living (ADL) score
Summary scores for ADL range from 0-14 and higher scores denote higher functional status.
Time frame: 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.
Time frame: baseline to 52 weeks
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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.