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

Primary Purpose

Breast Cancer, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic Training - Fixed Schedule
Resistance Training - Fixed Schedule
Walking program
Aerobic Training - Flexible Schedule
Resistance Training - Flexible Schedule
Successful Survivorship Health Education and Support Group
Flexible support groups
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Physical Activity, Breast Cancer, minority, African American

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
  • Metro Health Medical Center
  • Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1: Exercise Program

Group 2: Support Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Change in Activities of daily living (ADL) score
Summary scores for ADL range from 0-14 and higher scores denote higher functional status.
Change in Activities of daily living (ADL) score
Summary scores for ADL range from 0-14 and higher scores denote higher functional status.

Full Information

First Posted
April 27, 2016
Last Updated
March 21, 2022
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT02763228
Brief Title
Physical Activity Intervention to Reduce Functional Health Disparities Among Breast Cancer Survivors
Official Title
A Physical Activity Intervention to Reduce Functional Health Disparities Among Older Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 16, 2016 (Actual)
Primary Completion Date
March 25, 2020 (Actual)
Study Completion Date
November 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Physical Activity
Keywords
Physical Activity, Breast Cancer, minority, African American

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Exercise Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2: Support Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Training - Fixed Schedule
Other Intervention Name(s)
Aerobic exercise
Intervention Description
Supervised aerobic training for 40 minutes 3x/week for 20 weeks
Intervention Type
Behavioral
Intervention Name(s)
Resistance Training - Fixed Schedule
Intervention Description
Supervised resistance training for 20 minutes 3x/week for 20 weeks
Intervention Type
Behavioral
Intervention Name(s)
Walking program
Intervention Description
Unsupervised walking program 1-3 days/week for 52 weeks
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Training - Flexible Schedule
Intervention Description
Supervised aerobic training done on the participant's own schedule for 32 weeks
Intervention Type
Behavioral
Intervention Name(s)
Resistance Training - Flexible Schedule
Intervention Description
Supervised resistance training done on the participant's own schedule for 32 weeks
Intervention Type
Behavioral
Intervention Name(s)
Successful Survivorship Health Education and Support Group
Other Intervention Name(s)
Structured Support Group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Flexible support groups
Intervention Description
Participants will attend 1-3 weekly group sessions of their choosing for 32 weeks.
Primary Outcome Measure Information:
Title
Change in physical performance scores based on the Short Physical Performance Battery (SPPB)
Description
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.
Time Frame
baseline to 20 weeks
Secondary Outcome Measure Information:
Title
Change in SPPB scores
Description
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.
Time Frame
baseline to 52 weeks
Title
Change in Activities of daily living (ADL) score
Description
Summary scores for ADL range from 0-14 and higher scores denote higher functional status.
Time Frame
baseline to 20 weeks
Title
Change in Activities of daily living (ADL) score
Description
Summary scores for ADL range from 0-14 and higher scores denote higher functional status.
Time Frame
baseline to 52 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Owusu, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Metro Health Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35289926
Citation
Owusu C, Margevicius S, Nock NL, Austin K, Bennet E, Cerne S, Hergenroeder P, Moore HCF, Petkac J, Schluchter M, Schmitz KH, Webb Hooper M, Wimbley L, Berger NA. A randomized controlled trial of the effect of supervised exercise on functional outcomes in older African American and non-Hispanic White breast cancer survivors: Are there racial differences in the effects of exercise on functional outcomes? Cancer. 2022 Jun 15;128(12):2320-2338. doi: 10.1002/cncr.34184. Epub 2022 Mar 15.
Results Reference
derived
PubMed Identifier
33539554
Citation
Owusu C, Nock NL, Feuntes V, Margevicius S, Hergenroeder P, Austin K, Bennet E, Cerne S, Moore HCF, Petkac J, Schluchter M, Schmitz KH, Webb Hooper M, Coccia S, Nagy C, Wimbley L, Berger NA. IMPROVE, a community-based exercise intervention versus support group to improve functional and health outcomes among older African American and Non-Hispanic White breast cancer survivors from diverse socioeconomic backgrounds: Recruitment strategies and baseline characteristics. Cancer. 2021 Jun 1;127(11):1836-1846. doi: 10.1002/cncr.33430. Epub 2021 Feb 4.
Results Reference
derived

Learn more about this trial

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

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