Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors

Cardiovascular Diseases Clinical Trial

Official title:

Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05132998
• Other study ID #: CORE Trial
• Status: Completed
• Phase: N/A
• Start date: September 30, 2021
• Est. completion date: July 5, 2022

Study information

• Verified date: October 2022
• Source: Associacao de Investigacao de Cuidados de Suporte em Oncologia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 5, 2022
• Est. primary completion date: June 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Age >18 years
• Cancer survivors exposed to the following therapies:
• high-dose anthracycline or high dose radiotherapy in thoracic wall
• low-dose anthracycline or anti-human Epidermal growth factor Receptor-type 2 drugs (anti-HER2) alone plus = 2 CVRF and / or age = 60 years at cancer treatment
• low-dose anthracycline followed by anti-HER2;
• Cancer survivors with medical background of
• coronary artery disease
• moderate valvular disease
• LVEF <50%
• Follow up after primary treatment with curative intent
• Conclusion of primary treatment at least 2 months before the inclusion

Exclusion criteria:

• Previous participation in a CRP
• Contraindications to exercise training:
• musculoskeletal or neurologic disorders, cognitive impairment
• unstable angor pectoris, decompensated HF, active myocarditis, acute endocarditis, acute pulmonary thromboembolism, complex ventricular arrhythmias
• Active cancer
• Considered unsuitable as per principal investigator judgment (namely due to expected inability to fulfill proposed schedule)

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Oncologic Disorders

Intervention

Other:
• Cardiac Rehabilitation Program
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
• Community exercise intervention
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

Locations

Country	Name	City	State
Portugal	Centro Hospitalar Vila Nova de Gaia Espinho, E.P.E.	Vila Nova De Gaia	Porto

Sponsors (3)

Lead Sponsor	Collaborator
Associacao de Investigacao de Cuidados de Suporte em Oncologia	Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E., University Institute of Maia

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiorespiratory fitness	VO2peak measured by CPET	Change from baseline to 2 months
Secondary	Ventilatory efficiency	minute ventilation to carbon dioxide production slope (VE/VCO2 slope) assessed by CPET	Change from baseline to 2 months
Secondary	Sit-to-stand test	Sit-to-stand test during 60 seconds	Change from baseline to 2 months
Secondary	Handgrip maximal isometric muscle strength	muscle strength measured with manual dynamometers (Kgf)	Change from baseline to 2 months
Secondary	Body composition	Changes in body composition assessed by bioelectrical impedance analysis	Change from baseline to 2 months
Secondary	Resting diastolic blood pressure	Measured with an average of 3 readings by an automated measurement device as per the ESC guidelines (mmHg)	Change from baseline to 2 months
Secondary	Resting systolic blood pressure	Measured with an average of 3 readings by an automated measurement device as per the ESC guidelines (mmHg)	Change from baseline to 2 months
Secondary	Resting heart rate	Measured with an average of 3 readings by an automated measurement device (bpm)	Change from baseline to 2 months
Secondary	Hyperlipidemia	Measured through fasting Blood biochemistry including total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), high-density-lipoprotein cholesterol (HDL-C), triglycerides (TG)	Change from baseline to 2 months
Secondary	Diabetes control	Measured through glycated haemoglobin (%) in fasting state	Change from baseline to 2 months
Secondary	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)	Change from baseline to 2 months
Secondary	Physical Activity	objectively assessed by accelerometer, to wear for seven consecutive days	Change from baseline to 2 months
Secondary	Smoking Cessation	Cigarette smoking habits quantified in pack-year and cigarettes per day, to measure exposure to tobacco	Change from baseline to 2 months
Secondary	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	Change from baseline to 2 months
Secondary	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'.	Change from baseline to 2 months
Secondary	Fatigue	Fatigue score evaluated by the specific item on the EORTC QLQ-C30 questionnaire (high score representing high level of symptomatology)	Change from baseline to 2 months
Secondary	Health Literacy	Assessed by the Newest Vital Sign questionnaire; range score 0-6 (high score corresponding to high health literacy)	Change from baseline to 2 months
Secondary	Inflammatory markers- Interleukin-6 (IL-6)	Blood samples collected to access plasma levels of IL-6	Change from baseline to 2 months
Secondary	Inflammatory markers - High-sensitivity C-reactive protein	Blood samples collected to access plasma levels of high-sensitivity C-reactive protein	Change from baseline to 2 months
Secondary	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.	Through study recruitment, up to 2 years
Secondary	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	Change from baseline to 2 months
Secondary	Feasibility - Retention rate	number of participants who remained in the study (without formally drop out during intervention).	Change from baseline to 2 months
Secondary	Feasibility - Intervention adherence	total number of exercise sessions attended by participants allocated to this intervention group. Reasons for dropping out will be registered.	Change from baseline to 2 months
Secondary	Feasibility - Completion rate	number of patients that completed all the evaluations during the defined timeline.	Change from baseline to 2 months
Secondary	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	From baseline assessment up to 2 years