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

March 21, 2022 updated by: Case Comprehensive Cancer Center

A Physical Activity Intervention to Reduce Functional Health Disparities Among Older 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

218

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
      • Cleveland, Ohio, United States, 44109
        • Metro Health Medical Center
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group 1: Exercise Program

The exercise in this study will consist of two types of exercise training: resistance training and aerobic exercise. Resistance training is like "weight lifting" to improve strength and function. Participants will complete resistance training by using resistance machines and free weights. Aerobic exercise is exercise that intends to improve the cardiopulmonary or oxygen/lung and heart systems. It is often referred to as "cardio" exercise. Treadmill walking, stationary cycling sessions, and/or other exercises will be used for aerobic exercise.

Participants will be instructed in the exercise routine by physical fitness experts and trainers.
Behavioral: Aerobic Training - Fixed Schedule
Supervised aerobic training for 40 minutes 3x/week for 20 weeks
Other Names:
  • Aerobic exercise
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
ACTIVE_COMPARATOR: Group 2: Support Group

First 20 Weeks: Participants will take part in a structured Health Education and Support Group sessions once a week.

Last 32 weeks: Participants will be encouraged to take part in any of the Support Group sessions offered regularly on their own schedule.
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.
Other Names:
  • Structured Support Group
Behavioral: Flexible support groups
Participants will attend 1-3 weekly group sessions of their choosing for 32 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline to 20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline to 52 weeks
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.
baseline to 20 weeks
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.
baseline to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Cynthia Owusu, MD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 16, 2016

Primary Completion (ACTUAL)

March 25, 2020

Study Completion (ACTUAL)

November 6, 2020

Study Registration Dates

First Submitted

April 27, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (ESTIMATE)

May 5, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 22, 2022

Last Update Submitted That Met QC Criteria

March 21, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASE2116

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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