Trials / Completed
CompletedNCT02763228
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 218 (actual)
- Sponsor
- Case Comprehensive Cancer Center · Academic / Other
- Sex
- Female
- Age
- 65 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Aerobic Training - Fixed Schedule | Supervised aerobic training for 40 minutes 3x/week for 20 weeks |
| BEHAVIORAL | Resistance Training - Fixed Schedule | Supervised resistance training for 20 minutes 3x/week for 20 weeks |
| BEHAVIORAL | Walking program | Unsupervised walking program 1-3 days/week for 52 weeks |
| BEHAVIORAL | Aerobic Training - Flexible Schedule | Supervised aerobic training done on the participant's own schedule for 32 weeks |
| BEHAVIORAL | Resistance Training - Flexible Schedule | Supervised resistance training done on the participant's own schedule for 32 weeks |
| BEHAVIORAL | 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. |
| BEHAVIORAL | Flexible support groups | Participants will attend 1-3 weekly group sessions of their choosing for 32 weeks. |
Timeline
- Start date
- 2016-03-16
- Primary completion
- 2020-03-25
- Completion
- 2020-11-06
- First posted
- 2016-05-05
- Last updated
- 2022-03-22
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02763228. Inclusion in this directory is not an endorsement.