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

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ClinicalTrials.gov Identifier: NCT02763228
Recruitment Status : Recruiting
First Posted : May 5, 2016
Last Update Posted : July 2, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Physical Activity Behavioral: Aerobic Training - Fixed Schedule Behavioral: Resistance Training - Fixed Schedule Behavioral: Walking program Behavioral: Aerobic Training - Flexible Schedule Behavioral: Resistance Training - Flexible Schedule Behavioral: Successful Survivorship Health Education and Support Group Behavioral: Flexible support groups Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Physical Activity Intervention to Reduce Functional Health Disparities Among Older Breast Cancer Survivors
Actual Study Start Date : March 16, 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020


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 Name: 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 Name: Structured Support Group

Behavioral: Flexible support groups
Participants will attend 1-3 weekly group sessions of their choosing for 32 weeks.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02763228


Contacts
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Contact: Cynthia Owusu, MD 216-844-7670 cynthia.owusu@case.edu
Contact: Halle Moore, MD 216-445-4624 mooreh1@ccf.org

Locations
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United States, Ohio
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Cynthia Owusu, MD    216-844-7670    cynthia.owusu@case.edu   
Metro Health Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Paul Hergenroeder, MD    216-778-5360    phergenroeder@metrohealth.org   
The Gathering Place Not yet recruiting
Cleveland, Ohio, United States, 44122
Contact: Ellen Heyman, MSN, RN, CS       heyman@touchedbycancer.org   
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Halle Moore, MD    216-445-4624    mooreh1@ccf.org   
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Cynthia Owusu, MD University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02763228     History of Changes
Other Study ID Numbers: CASE2116
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Case Comprehensive Cancer Center:
Physical Activity
Breast Cancer
minority
African American

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases