Cardio-Oncology Rehabilitation Exercise
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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.
Primary outcome measures
- Cardiopulmonary Fitness [Time frame: post-intervention (16 weeks)]
Secondary outcome measures (11)
- Visceral adipose tissue [Time frame: post-intervention (16 weeks)]
- Left ventricular ejection fraction [Time frame: post-intervention (16 weeks)]
- Native myocardial T1 time [Time frame: post-intervention (16 weeks)]
- Left ventricular mass [Time frame: post-intervention (16 weeks)]
- lipid profile [Time frame: post-intervention (16 weeks)]
- Fasting glucose [Time frame: post-intervention (16 weeks)]
- hemoglobin A1c [Time frame: post-intervention (16 weeks)]
- Cancer-specific, health-related quality of life [Time frame: post-intervention (16 weeks)]
- Depressive symptoms [Time frame: post-intervention (16 weeks)]
- Psychosocial Stress [Time frame: post-intervention (16 weeks)]
- Cancer-related fatigue [Time frame: post-intervention (16 weeks)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- Toronto Rehabilitation Institute — Toronto
Identifiers
NCT: NCT05522959 · 19-5080