Many cancer survivors are at risk for cardiovascular disease (CVD); it is therefore important to identify patients at increased risk for cardiotoxicity, especially in the setting of CVRF or pre-existing CVD, and to design personalized interventions to prevent cardiovascular morbidity. In this background, cardio-oncology rehabilitation frameworks for specific cancer patients have been proposed. Given potential beneficial effects of exercise among cancer patients (including those at higher risk of CVD), data pertaining to optimal program designs are of paramount contemporary importance. Thus, the aim of this study is to compare the impact of a Cardiac Rehabilitation Program (CRP) model versus a community-based exercise intervention plus usual care on cardiorespiratory fitness (CRF), physical function domains and CVRF control in adult cancer survivors who have been exposed to cardiotoxic cancer treatment and/or with cardiovascular medical background. Study outcomes will be assessed at baseline (M0) and after an 8 weeks-intervention (M1), comprising maximal aerobic capacity (peak oxygen uptake), muscular strength, neuromuscular function, single CVRF control including physical activity measurements and psychosocial parameters, health-related quality of life, fatigue, health literacy, inflammatory response and feasibility metrics; an economic evaluation will provide quantitative comparison, for a cost-effectiveness analysis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
In addition to standard medical care, for an 8-week period, patients will have access to the core components of a CRP, delivered by a multidisciplinary rehabilitation team
In addition to standard medical care, for an 8-week period, patients will have access to a community exercise intervention oriented by a sports professional
Centro Hospitalar Vila Nova de Gaia Espinho, E.P.E.
Vila Nova de Gaia, Porto District, Portugal
Cardiorespiratory fitness
VO2peak measured by CPET
Time frame: Change from baseline to 2 months
Ventilatory efficiency
minute ventilation to carbon dioxide production slope (VE/VCO2 slope) assessed by CPET
Time frame: Change from baseline to 2 months
Sit-to-stand test
Sit-to-stand test during 60 seconds
Time frame: Change from baseline to 2 months
Handgrip maximal isometric muscle strength
muscle strength measured with manual dynamometers (Kgf)
Time frame: Change from baseline to 2 months
Body composition
Changes in body composition assessed by bioelectrical impedance analysis
Time frame: Change from baseline to 2 months
Resting diastolic blood pressure
Measured with an average of 3 readings by an automated measurement device as per the ESC guidelines (mmHg)
Time frame: Change from baseline to 2 months
Resting systolic blood pressure
Measured with an average of 3 readings by an automated measurement device as per the ESC guidelines (mmHg)
Time frame: Change from baseline to 2 months
Resting heart rate
Measured with an average of 3 readings by an automated measurement device (bpm)
Time frame: Change from baseline to 2 months
Hyperlipidemia
Measured through fasting Blood biochemistry including total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), high-density-lipoprotein cholesterol (HDL-C), triglycerides (TG)
Time frame: Change from baseline to 2 months
Diabetes control
Measured through glycated haemoglobin (%) in fasting state
Time frame: Change from baseline to 2 months
Physical Activity
Self-reported through the International Physical Activity Questionnaire, classifying the activity in three categories (low activity levels, moderate activity levels or high activity levels)
Time frame: Change from baseline to 2 months
Physical Activity
objectively assessed by accelerometer, to wear for seven consecutive days
Time frame: Change from baseline to 2 months
Smoking Cessation
Cigarette smoking habits quantified in pack-year and cigarettes per day, to measure exposure to tobacco
Time frame: Change from baseline to 2 months
Depression and anxiety
Psychosocial parameters assessed through the Hospital Anxiety and Depression Score questionnaire. Scores 0-14. A sub-scale score \> 8 denotes anxiety or depression symptoms
Time frame: Change from baseline to 2 months
Health Related Quality of Life
Evaluated using the EuroQuol Five- Dimensional questionnaire ( EQ-5D-5L). It consists in five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ - Visual Analog Scale records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Time frame: Change from baseline to 2 months
Fatigue
Fatigue score evaluated by the specific item on the EORTC QLQ-C30 questionnaire (high score representing high level of symptomatology)
Time frame: Change from baseline to 2 months
Health Literacy
Assessed by the Newest Vital Sign questionnaire; range score 0-6 (high score corresponding to high health literacy)
Time frame: Change from baseline to 2 months
Inflammatory markers- Interleukin-6 (IL-6)
Blood samples collected to access plasma levels of IL-6
Time frame: Change from baseline to 2 months
Inflammatory markers - High-sensitivity C-reactive protein
Blood samples collected to access plasma levels of high-sensitivity C-reactive protein
Time frame: Change from baseline to 2 months
Feasibility - Consent rate
number of patients who met inclusion criteria divided by the number who consented in writing to participate. Reasons for not participating in the study will be registered.
Time frame: Through study recruitment, up to 2 years
Testing and Intervention Adverse events
all the events will be recorded and registered as "related" or "unrelated" to the intervention itself, as well as the impact for exercise concerns or other health intervention required
Time frame: Change from baseline to 2 months
Feasibility - Retention rate
number of participants who remained in the study (without formally drop out during intervention).
Time frame: Change from baseline to 2 months
Feasibility - Intervention adherence
total number of exercise sessions attended by participants allocated to this intervention group. Reasons for dropping out will be registered.
Time frame: Change from baseline to 2 months
Feasibility - Completion rate
number of patients that completed all the evaluations during the defined timeline.
Time frame: Change from baseline to 2 months
Cost-effectiveness analysis
Incremental cost per quality-adjusted life. Costs will be calculated from the provider perspective, which includes the costs incurred by the health institution providing health services; and from the societal perspective
Time frame: From baseline assessment up to 2 years
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