Cardiac Rehabilitation Program in Improving Cardiorespiratory Fitness in Stage 0-III Breast Cancer Survivors

February 23, 2022 updated by: Ohio State University Comprehensive Cancer Center

A Cardiac Rehabilitation Program for Breast Cancer Survivors: A Feasibility Study

This clinical trial studies a cardiac rehabilitation program in improving cardiorespiratory fitness in stage 0-III breast cancer survivors. Cardiovascular disease is the leading cause of death of women in both the general population and the breast cancer survivor population. There are many risk factors common to both heart disease and breast cancer development, including physical inactivity. A cardiac rehabilitation program may help improve cardiorespiratory fitness, reduce cardiovascular disease risk factors, and improve quality of life among breast cancer survivors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. Assess the feasibility of conducting a 14-week cardiac rehabilitation (CR) program in women with breast cancer after completion of acute therapy.

II. Preliminarily evaluate the efficacy of CR in improving cardiorespiratory fitness (peak oxygen uptake, maximum volume of oxygen [VO2 max]) at baseline and 14 weeks.

III. Explore changes in cardiovascular disease (CVD) risk factors (blood pressure, cholesterol, fasting glucose, and body mass index) between baseline and 14-week follow-up. Blood pressure and body mass index will also be checked at 8 weeks.

IV. Quantify the difference in quality of life (QoL) between baseline, 8 week, and 14 week follow up, adjusting for baseline QoL values.

OUTLINE:

Patients participate in a CR program consisting of 1-hour CR intervention sessions, based on a personalized exercise prescription, 3 times per week for 14 weeks (a total of 36 sessions). Components of the exercise prescription includes intensity, mode, duration, and frequency. Intensity of exercise is guided by the results of a graded exercise stress test, rating of perceived exertion (RPE), heart rate, and symptoms, such as chest pain/angina or shortness of breath. If exercise is well-tolerated during CR sessions, patients are encouraged to supplement their exercise program at home, increasing their exercise frequency to up to 5 times per week. Patients may attend weekly educational sessions offered by the Phase 2 CR program which covers topics such as stress management, smoking cessation, nutrition, and weight loss.

Study Type

Interventional

Enrollment (Actual)

25

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
      • Columbus, Ohio, United States, 43210
        • Ohio State University 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

30 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Diagnosed with breast cancer stages 0-III within 6 months after completion of all planned surgery, radiation and or chemotherapy treatments
  • Concurrent endocrine therapy permissible
  • Ability to understand and the willingness to sign a written informed consent
  • Willingness to participate in CR program

Exclusion Criteria:

  • Existing CVD
  • Existing diabetes
  • Contraindications to exercise
  • Metastatic breast cancer
  • Other concurrent malignancies except skin cancer
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situation that would limit compliance with study requirements
  • Pregnant or nursing women
  • Unable to give informed consent
  • Any contraindication to cardiac stress testing
  • Travel distance greater than 50 miles

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Supportive care (CR program)
Patients participate in a CR program consisting of 1-hour CR intervention sessions, based on a personalized exercise prescription, 3 times per week for 14 weeks (a total of 36 sessions). Components of the exercise prescription includes intensity, mode, duration, and frequency. Intensity of exercise is guided by the results of a graded exercise stress test, RPE, heart rate, and symptoms, such as chest pain/angina or shortness of breath. If exercise is well-tolerated during CR sessions, patients are encouraged to supplement their exercise program at home, increasing their exercise frequency to up to 5 times per week. Patients may attend weekly educational sessions offered by the Phase 2 CR program which covers topics such as stress management, smoking cessation, nutrition, and weight loss.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Educational Intervention
Attend weekly educational sessions
Other Names:
  • Education for Intervention
  • Intervention, Educational
Behavioral: Exercise Intervention
Participate in CR program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of conducting a 14-week CR program
Time Frame: 14 weeks
During the course of the 14-week intervention period, the CR medical director will monitor CR staff adherence to the study protocol. Every 2 weeks, they will review intervention participants' baseline graded exercise test results and subsequent exercise prescriptions to ensure the intervention is targeted at the appropriate level of each participant's VO2 max. Will administer a satisfaction questionnaire to intervention participants. Results from these surveys will be evaluated during the course of the study by the principal investigator and used to improve the study process as appropriate.
14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of CR in improving cardiorespiratory fitness
Time Frame: At 14 weeks
Analysis of follow-up VO2 max, in units of mL/kg/min, will be done using an analysis of covariance (ANCOVA) approach. If VO2 max values are missing at 14 weeks, will use the Duke Activity Status Index questionnaire responses to approximate VO2 max values.
At 14 weeks

Collaborators and Investigators

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

Sponsor

Ohio State University 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.

Helpful Links

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)

May 14, 2015

Primary Completion (ACTUAL)

October 23, 2018

Study Completion (ACTUAL)

December 31, 2021

Study Registration Dates

First Submitted

March 7, 2016

First Submitted That Met QC Criteria

January 30, 2017

First Posted (ESTIMATE)

February 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2022

Last Update Submitted That Met QC Criteria

February 23, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-14060
  • NCI-2015-00810 (REGISTRY: CTRP (Clinical Trial Reporting Program))

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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