Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors
- Conditions
- Oncologic DisordersCardiovascular Diseases
- Interventions
- Other: Community exercise interventionOther: Cardiac Rehabilitation Program
- Registration Number
- NCT05132998
- Lead Sponsor
- Associacao de Investigacao de Cuidados de Suporte em Oncologia
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Community Exercise Group Community exercise intervention a) Besides standard medical and supportive care, psychological and nutritional individual support will be offered on demand, in hospital setting, according to the attending physician standard clinical assessment and usual care. Exercise intervention - Performed at a community-based facility, comprising 2 sessions/week, prescribed according to current physical activity guidelines for cancer survivors. Exercise intervention will be conducted by an exercise physiologist, internationally certified in exercise for cancer patients Cardiac Rehabilitation Program (CRP) Group Cardiac Rehabilitation Program 1. Baseline consultation with physiatrist specialized in CRP - addressing CVRF control, comorbidities and disabilities; case-by-case discussion with a cardiologist specialized in CR will be undertaken, for tailoring exercise prescription. Nutritional individualized plan addressing dietary goals. Psychological management addressing psychosocial outcomes and motivation for healthy lifestyle habits 2. Multidisciplinary team educational meeting: periodic group sessions with health education purposes 3. Exercise intervention - 2 times/week sessions at CR facilities, supervised by a physiatrist, conducted by physiotherapist. Heart rate (HR) continuously monitored during each session by remote electrocardiographic monitoring or HR monitor. Exercise intensity estimated according to CR guidelines, determined after CV risk stratification, using CPET results.
- Primary Outcome Measures
Name Time Method Cardiorespiratory fitness Change from baseline to 2 months VO2peak measured by CPET
- Secondary Outcome Measures
Name Time Method Ventilatory efficiency Change from baseline to 2 months minute ventilation to carbon dioxide production slope (VE/VCO2 slope) assessed by CPET
Health Literacy Change from baseline to 2 months Assessed by the Newest Vital Sign questionnaire; range score 0-6 (high score corresponding to high health literacy)
Sit-to-stand test Change from baseline to 2 months Sit-to-stand test during 60 seconds
Handgrip maximal isometric muscle strength Change from baseline to 2 months muscle strength measured with manual dynamometers (Kgf)
Body composition Change from baseline to 2 months Changes in body composition assessed by bioelectrical impedance analysis
Diabetes control Change from baseline to 2 months Measured through glycated haemoglobin (%) in fasting state
Depression and anxiety Change from baseline to 2 months Psychosocial parameters assessed through the Hospital Anxiety and Depression Score questionnaire. Scores 0-14. A sub-scale score \> 8 denotes anxiety or depression symptoms
Cost-effectiveness analysis From baseline assessment up to 2 years 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
Resting diastolic blood pressure Change from baseline to 2 months Measured with an average of 3 readings by an automated measurement device as per the ESC guidelines (mmHg)
Resting systolic blood pressure Change from baseline to 2 months Measured with an average of 3 readings by an automated measurement device as per the ESC guidelines (mmHg)
Resting heart rate Change from baseline to 2 months Measured with an average of 3 readings by an automated measurement device (bpm)
Hyperlipidemia Change from baseline to 2 months Measured through fasting Blood biochemistry including total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), high-density-lipoprotein cholesterol (HDL-C), triglycerides (TG)
Smoking Cessation Change from baseline to 2 months Cigarette smoking habits quantified in pack-year and cigarettes per day, to measure exposure to tobacco
Fatigue Change from baseline to 2 months Fatigue score evaluated by the specific item on the EORTC QLQ-C30 questionnaire (high score representing high level of symptomatology)
Inflammatory markers- Interleukin-6 (IL-6) Change from baseline to 2 months Blood samples collected to access plasma levels of IL-6
Physical Activity Change from baseline to 2 months objectively assessed by accelerometer, to wear for seven consecutive days
Health Related Quality of Life Change from baseline to 2 months 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'.
Inflammatory markers - High-sensitivity C-reactive protein Change from baseline to 2 months Blood samples collected to access plasma levels of high-sensitivity C-reactive protein
Feasibility - Consent rate Through study recruitment, up to 2 years 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.
Testing and Intervention Adverse events Change from baseline to 2 months 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
Feasibility - Retention rate Change from baseline to 2 months number of participants who remained in the study (without formally drop out during intervention).
Feasibility - Intervention adherence Change from baseline to 2 months total number of exercise sessions attended by participants allocated to this intervention group. Reasons for dropping out will be registered.
Feasibility - Completion rate Change from baseline to 2 months number of patients that completed all the evaluations during the defined timeline.
Trial Locations
- Locations (1)
Centro Hospitalar Vila Nova de Gaia Espinho, E.P.E.
🇵🇹Vila Nova De Gaia, Porto, Portugal