Cardio-Oncology Rehabilitation Care Process
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
- The protocol lists: Exercise-based cardio-oncology rehabilitation.
- Who it may be relevant to
- Registry conditions: Cardio-Oncology, Rehabilitation, Cardiovascular Diseases, Exercise. Basic parameters: 18 years — 70 years · All.
- 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
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Hospital-based Cardio-Oncology Rehabilitation Care Process for Cardiovascular Health in Cancer Patients
Overview
The objective of this observational study is to assess the outcomes of a hospital-based Cardio-Oncology Rehabilitation (CORe) program focused on exercise in cancer patients undergoing cardiotoxic treatment. This evaluation will be conducted by analyzing disease-related health indicators, functional capacity, and quality of life. Patients at risk of cardiotoxicity attending the Cardio-Onco-Hematology Unit will be offered the exercise program, which includes two modalities: in-person (center-based) and remote (home-based) options. The assignment to either modality is non randomized, based on the functional assessment conducted in the Rehabilitation Unit and the agreement between healthcare professional and patient. All participants will perform a 3-month supervised exercise intervention. There are 3 time points for assessment: at baseline (T0), 3-month after the exercise program (T1) and follow-up at 9 months from baseline (T2).
Detailed description
Advancements in pharmacological cancer treatment have significantly improved prognosis and increased survival rates. However, the chronicity of treatment-related side effects or associated comorbidities may be exacerbated. Various chemotherapy treatments are associated with the potential development of cardiovascular diseases, such as cardiotoxicity, which stands as a main cause of death among women with early-stage breast cancer. Additionally, other side effects, such as fatigue, loss of muscle mass, insomnia, lymphedema, and cognitive impairments, can markedly decline the quality of life of these patients.
The comprehensive care of oncology patients should extend beyond curative interventions like surgery, radiotherapy, or chemotherapy. It must encompass other aspects, such as psychological support, social support and therapeutic exercise programs to enhance the overall treatment experience and improve the quality of life. Exercise has proven to reduce mortality, morbidity, and the risk of recurrence, improving treatment tolerance and reducing interruptions, thereby promoting adherence. Supervised exercise programs are increasingly recognized as a low-cost and a side-effect-free "polypill". However, they have not yet been integrated into the standard care of patients with cancer.
The inherited experience from multimodal Cardiac Rehabilitation (CR) programs with a comprehensive assessment and a multifaceted intervention with exercise programs as a central component; could be extended to cancer patients, resulting in a CORe program (ReCO in Spanish) by utilizing available CR programs in all healthcare areas.
The proposed CORe care process is grounded in the prior experience with the ONCORE trial (Clinicaltrials.gov: NCT03964142), which has helped in the implementation of new, structured, and controlled healthcare service, ensuring higher quality, safety, and efficiency in healthcare.
The implementation of the CORe program will take place at the University Hospital Complex of Santiago de Compostela (CHUS), under the coordination of the Cardiology, Oncology, and Rehabilitation services. The management of participants data and the establishment of indicators should facilitate the monitoring of the process and the evaluation of the results of clinical interventions.
The goal of this project is to assess the outcomes of a CORe care process through the analysis of health-related indicators, functional capacity, and the quality of life of breast cancer participants attending the Cardio-Oncology Unit.
Interventions
- Other Exercise-based cardio-oncology rehabilitation
Within the multidisciplinary approach of cardio-oncology rehabilitation, the exercise program will include recommendation and supervision of strength, aerobic and mobility exercises.
Primary outcome measures
- Change in left ventricular systolic function quantified by left ventricular ejection fraction and global longitudinal strain by transthoracic echocardiography [Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2); every year after study completion up to a maximum of 5 years]
- Increased cardiac biomarkers (Troponin I and BNP/NT-proBNP) [Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2); every year after study completion up to a maximum of 5 years]
- Decrease in functional capacity assessed by estimated VO2peak [Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)]
- Change in cardiovascular risk profile as assessed by the presence or absence of classic cardiovascular risk factors. [Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2); every year after study completion up to a maximum of 5 years]
- Changes in fasting blood glucose [Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2); every year after study completion up to a maximum of 5 years]
- Changes in total low-density lipoprotein (LDL) and total cholesterol (TC) levels [Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2); every year after study completion up to a maximum of 5 years]
- Change in haemoglobin [Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2); every year after study completion up to a maximum of 5 years]
- Significant cardiovascular and non-cardiovascular adverse effects during treatment. [Time frame: Date of the event throughout the study.]
Secondary outcome measures (12)
- Change in health-related quality of life assessed by the Functional Assessment of Cancer Therapy - Breast plus Arm Morbidity (FACT-B+4) questionnaire. [Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)]
- Change in localized lower limb functional capacity assessed by number of repetitions performed within 30 seconds in the sit-to-stand test. [Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)]
- Change in lower limb strength measured by squat dynamometry (kg). [Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)]
- Change in biceps strength by dynamometry (kg). [Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)]
- Change in perimeter (cm) of the right thigh 5cm above the upper edge of the patella [Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)]
- Changes in peak expiratory flow [Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)]
- Change in upper limb strength measured by dynamometry (kg). [Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)]
- Change in anthropometric parameters: weight in kg. [Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)]
- Change in anthropometric parameters: Body mass index (BMI) in kg/m^2 [Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)]
- Change in anthropometric parameters: abdominal circumference in cm. [Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)]
- Change in resting heart rate measured by pulse oximetry (beats per min). [Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)]
- Change in resting blood pressure (mmHg) measured by a blood pressure monitor. [Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)]
Eligibility criteria
Inclusion criteria
- High risk of cancer treatment-related cardiotoxicity
- Possibility of completing a cardio-onco rehabilitation program (centre-based or home-based) and programmed visits.
- Providing written informed consent.
Exclusion criteria
- Patients with physical or mental limitation to carry out an exercise program.
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
Spain · 1 center
- Hospital Clínico Universitario de Santiago — Santiago de Compostela
Identifiers
NCT: NCT06302634 · ReCO · 2022/137