Cardio-Oncology Rehabilitation Exercise (CORE)

December 1, 2023 updated by: Amy Kirkham, University of Toronto

A Single Arm Intervention Study to Assess the Role of Structured Cardio-Oncology Rehabilitation Exercise to Improve Cardiovascular Health in Early Stage Breast Cancer Survivors (CORE Study)

Women with breast cancer who are referred to the cardiac rehabilitation program at the Toronto Rehabilitation Institute will be invited to enrol in this observational study. Participants will take part in an established 16-week multimodal cardiac rehabilitation program (HEALTh program) at Toronto Rehabilitation Institute and outcome measures will be assessed before and after program participation to determine the effectiveness of the program in improving cardio metabolic health. Change in VO₂peak will be assessed using Cardiopulmonary Exercise Test (CPET). Traditional cardiac risk factors, lifestyle behaviours, exercise adherence, health-related quality of life, and fatigue will also be assessed.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

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

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Recruiting
        • Toronto Rehabilitation Institute
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Female early-stage breast cancer survivors.

Description

Inclusion Criteria:

  • History of early-stage breast cancer (I-III)
  • Currently receiving or have completed adjuvant therapy (i.e. chemotherapy, surgery, radiation, targeted therapies)
  • Able to communicate in English

Exclusion Criteria:

  • Pregnancy
  • Metastatic disease (Stage IV)
  • Unable or unwilling to complete cardiopulmonary exercise test

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiopulmonary Fitness
Time Frame: post-intervention (16 weeks)
VO2peak assessed using cardiopulmonary exercise test
post-intervention (16 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visceral adipose tissue
Time Frame: post-intervention (16 weeks)
Measured only in a subset (n=30) of participants via 1.5T MRI.
post-intervention (16 weeks)
Left ventricular ejection fraction
Time Frame: post-intervention (16 weeks)
Measured only in a subset (n=30) of participants via 1.5T MRI.
post-intervention (16 weeks)
Native myocardial T1 time
Time Frame: post-intervention (16 weeks)
Measured only in a subset (n=30) of participants via 1.5T MRI.
post-intervention (16 weeks)
Left ventricular mass
Time Frame: post-intervention (16 weeks)
Measured only in a subset (n=30) of participants via 1.5T MRI.
post-intervention (16 weeks)
lipid profile
Time Frame: post-intervention (16 weeks)
Assessed via fasting blood draw
post-intervention (16 weeks)
Fasting glucose
Time Frame: post-intervention (16 weeks)
Assessed via fasting blood draw
post-intervention (16 weeks)
hemoglobin A1c
Time Frame: post-intervention (16 weeks)
Assessed via fasting blood draw
post-intervention (16 weeks)
Cancer-specific, health-related quality of life
Time Frame: post-intervention (16 weeks)
Functional Assessment of Cancer Therapy (FACT) questionnaire. Minimum score = 0, maximum score = 108, with higher score representing better quality of life.
post-intervention (16 weeks)
Depressive symptoms
Time Frame: post-intervention (16 weeks)
Patient Health Questionnaire 9 scale. Minimum value = 0, maximum value = 27, where higher score represents more depressive symptoms.
post-intervention (16 weeks)
Psychosocial Stress
Time Frame: post-intervention (16 weeks)
Perceived Stress Scale (PSS). Minimum value = 0, maximum value = 56, where higher score represents more perceived stress.
post-intervention (16 weeks)
Cancer-related fatigue
Time Frame: post-intervention (16 weeks)
Fatigue sub-scale of the Functional Assessment of Cancer Therapy (FACT) questionnaire. Minimum score = 0, maximum score = 52, with higher score representing less fatigue.
post-intervention (16 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoking Status
Time Frame: post-intervention (16 weeks)
Smoking assessment history questionnaire
post-intervention (16 weeks)
Moderate-Intensity Physical Activity Time
Time Frame: averaged over 7 days post-intervention
PiezoRx® will be worn by participants for 7 days with data used to assess moderate activity time (>100 steps per minute)
averaged over 7 days post-intervention
Vigorous-intensity Physical Activity
Time Frame: averaged over 7 days post-intervention
PiezoRx® will be worn by participants for 7 days with data used to assess vigorous activity time (>120 steps per minute)
averaged over 7 days post-intervention
Physical Activity Bouts per Day
Time Frame: averaged over 7 days post-intervention
PiezoRx® will be worn by participants for 7 days with data used to assess bouts of physical activity per day (greater than 10 minutes of moderate/vigorous activity)
averaged over 7 days post-intervention
Total daily steps
Time Frame: averaged over 7 days post-intervention
PiezoRx® will be worn by participants for 7 days with data used to assess total daily steps
averaged over 7 days post-intervention
Self-Reported Physical Activity
Time Frame: post-intervention (16 weeks)
Godin Leisure Time Physical Activity Questionnaire
post-intervention (16 weeks)
Diet quality
Time Frame: post-intervention (16 weeks)
Rapid Eating and Activity Assessment for Participants (REAP) questionnaire. Minimum score = 13, maximum score = 39, with a higher score indicating a higher diet quality.
post-intervention (16 weeks)

Collaborators and Investigators

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

Sponsor

University of Toronto

Collaborators

Toronto Rehabilitation Institute

Investigators

  • Principal Investigator: Amy Kirkham, PhD, University of Toronto

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 14, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 15, 2022

First Submitted That Met QC Criteria

August 28, 2022

First Posted (Actual)

August 31, 2022

Study Record Updates

Last Update Posted (Estimated)

December 4, 2023

Last Update Submitted That Met QC Criteria

December 1, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-5080

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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