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Completed

NCT Number: NCT02763228

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

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.

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Key information

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aerobic Training - Fixed Schedule

Behavioral

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

Other names: Aerobic exercise

Resistance Training - Fixed Schedule

Behavioral

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

Walking program

Behavioral

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

Aerobic Training - Flexible Schedule

Behavioral

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

Resistance Training - Flexible Schedule

Behavioral

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

Successful Survivorship Health Education and Support Group

Behavioral

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.

Other names: Structured Support Group

Flexible support groups

Behavioral

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

Primary outcomes

  1. Change in physical performance scores based on the Short Physical Performance Battery (SPPB)

    Time frame: baseline to 20 weeks

    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.

Secondary outcomes

  1. Change in SPPB scores

    Time frame: baseline to 52 weeks

    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.

  2. Change in Activities of daily living (ADL) score

    Time frame: baseline to 20 weeks

    Summary scores for ADL range from 0-14 and higher scores denote higher functional status.

  3. Change in Activities of daily living (ADL) score

    Time frame: baseline to 52 weeks

    Summary scores for ADL range from 0-14 and higher scores denote higher functional status.

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
May 5, 2016
Registry last updated
Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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