Physical Activity in Reducing Functional Health Disparities in Older Stage I-III Breast Cancer Survivors

Status: Active

Description

This randomized phase III trial studies physical activity in reducing functional health disparities in older stage I-III breast cancer survivors. Increased physical activity among older breast cancer survivors may help to improve functional and overall health status.

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
  • 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 medical clearance from a physician
  • 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

Locations & Contacts

Michigan

Wyoming
Metro Health Hospital
Status: Active
Contact: Paul Francis Hergenroeder
Phone: 216-778-5360
Email: phergenroeder@metrohealth.org

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: Active
Contact: Cynthia Owusu
Phone: 216-844-7670
Email: cynthia.owusu@case.edu
Cleveland Clinic Foundation
Status: Active
Contact: Halle Crile Foster Moore
Phone: 216-445-4624
Email: mooreh1@ccf.org
Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Status: Active
Contact: Cynthia Owusu
Phone: 216-844-7670
Email: cynthia.owusu@case.edu
The Gathering Place
Status: Active
Contact: Ellen Heyman
Email: heyman@touchedbycancer.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. 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 (BCa) survivors who are within five years of treatment completion for stage I-III BCa.

II. To examine whether race and socio-economic status (SES) moderate the intervention effect on physical activity (PA) levels and functional outcomes at 20 and 52 weeks

III. To examine the effect of the PA intervention on longitudinal changes in beliefs, attitudes, preferences (KAPs) and PA levels, and the extent to which changes in these factors mediate intervention effect on functional outcomes.

IV. To determine the effect of the PA intervention on surrogate biomarkers associated with breast cancer prognosis and functional disability.

OUTLINE: Patients are randomized into 1 of 2 groups.

GROUP I: Patients undergo supervised aerobic exercise over 40 minutes and resistance training over 20 minutes 3 times per week for 20 weeks. Patients then participate in regular exercise sessions on flexible schedule for 32 weeks.

GROUP II: Patients participate in structured health education and support group sessions over 60 minutes once per week for 20 weeks. Patients then participate in support group sessions for 32 weeks.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Supportive care

Lead Organization

Lead Organization
Case Comprehensive Cancer Center

Principal Investigator
Cynthia Owusu

Trial IDs

Primary ID CASE2116
Secondary IDs NCI-2016-01773
Clinicaltrials.gov ID NCT02763228