Physical Activity Intervention to Reduce Functional Health Disparities Among Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

A Physical Activity Intervention to Reduce Functional Health Disparities Among Older Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02763228
• Other study ID #: CASE2116
• Status: Completed
• Phase: N/A
• Start date: March 16, 2016
• Est. completion date: November 6, 2020

Study information

• Verified date: March 2022
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: November 6, 2020
• Est. primary completion date: March 25, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Physical Activity

Intervention

Behavioral:
• Aerobic Training - Fixed Schedule
Supervised aerobic training for 40 minutes 3x/week for 20 weeks
• Resistance Training - Fixed Schedule
Supervised resistance training for 20 minutes 3x/week for 20 weeks
• Walking program
Unsupervised walking program 1-3 days/week for 52 weeks
• Aerobic Training - Flexible Schedule
Supervised aerobic training done on the participant's own schedule for 32 weeks
• Resistance Training - Flexible Schedule
Supervised resistance training done on the participant's own schedule for 32 weeks
• 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.
• Flexible support groups
Participants will attend 1-3 weekly group sessions of their choosing for 32 weeks.

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center	Cleveland	Ohio
United States	Metro Health Medical Center	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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 20 weeks
Secondary	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