Clinical Trials Directory

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

TypeNameDescription
BEHAVIORALAerobic Training - Fixed ScheduleSupervised aerobic training for 40 minutes 3x/week for 20 weeks
BEHAVIORALResistance Training - Fixed ScheduleSupervised resistance training for 20 minutes 3x/week for 20 weeks
BEHAVIORALWalking programUnsupervised walking program 1-3 days/week for 52 weeks
BEHAVIORALAerobic Training - Flexible ScheduleSupervised aerobic training done on the participant's own schedule for 32 weeks
BEHAVIORALResistance Training - Flexible ScheduleSupervised resistance training done on the participant's own schedule for 32 weeks
BEHAVIORALSuccessful Survivorship Health Education and Support GroupSupport 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.
BEHAVIORALFlexible support groupsParticipants 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.