Skip to content

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02763228
Enrollment
218
Registered
2016-05-05
Start date
2016-03-16
Completion date
2020-11-06
Last updated
2022-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Physical Activity

Keywords

Physical Activity, Breast Cancer, minority, African American

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.

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.

Interventions

BEHAVIORALSuccessful 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.

BEHAVIORALAerobic Training - Fixed Schedule

Supervised aerobic training for 40 minutes 3x/week for 20 weeks

BEHAVIORALResistance Training - Fixed Schedule

Supervised resistance training for 20 minutes 3x/week for 20 weeks

BEHAVIORALWalking program

Unsupervised walking program 1-3 days/week for 52 weeks

BEHAVIORALAerobic Training - Flexible Schedule

Supervised aerobic training done on the participant's own schedule for 32 weeks

BEHAVIORALResistance Training - Flexible Schedule

Supervised resistance training done on the participant's own schedule for 32 weeks

BEHAVIORALFlexible support groups

Participants will attend 1-3 weekly group sessions of their choosing for 32 weeks.

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
Case Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Change in physical performance scores based on the Short Physical Performance Battery (SPPB)baseline to 20 weeksChange 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.

Secondary

MeasureTime frameDescription
Change in SPPB scoresbaseline to 52 weeksChange 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.
Change in Activities of daily living (ADL) scorebaseline to 20 weeksSummary scores for ADL range from 0-14 and higher scores denote higher functional status.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026