Hospital-based Cardio-Oncology Rehabilitation Care Process for Cardiovascular Health in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change in left ventricular systolic function quantified by left ventricular ejection fraction and global longitudinal strain by transthoracic echocardiography
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients with physical or mental limitation to carry out an exercise program.
结局指标
主要结局
Change in left ventricular systolic function quantified by left ventricular ejection fraction and global longitudinal strain by transthoracic echocardiography
时间窗: 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
Fall of 10 absolute percentage points of left ventricular ejection fraction from baseline or with final value below 53% or global longitudinal strain fall \>15% with respect to baseline
Increased cardiac biomarkers (Troponin I and BNP/NT-proBNP)
时间窗: 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
cTnI/T\>percentil 99, BNP≥35 pg/mL, NT-proBNP≥125 pg/mL
Decrease in functional capacity assessed by estimated VO2peak
时间窗: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
To estimate VO2peak, the ONCORE equation developed in the following article is used: Díaz-Balboa, E., González-Salvado, V., Rodríguez-Romero, B. et al. Thirty-second sit-to-stand test as an alternative for estimating peak oxygen uptake and 6-min walking distance in women with breast cancer: a cross-sectional study. Support Care Cancer 30, 8251-8260 (2022). https://doi.org/10.1007/s00520-022-07268-z
Change in cardiovascular risk profile as assessed by the presence or absence of classic cardiovascular risk factors.
时间窗: 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
Dyslipidemia, Diabetes mellitus, Arterial Hypertension, Smoking status
Changes in fasting blood glucose
时间窗: 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
Value of fasting blood glucose (mg/dL) in blood tests
Changes in total low-density lipoprotein (LDL) and total cholesterol (TC) levels
时间窗: 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
Value of LDL \>160 mg/dL or CT\> 200 mg/dL in blood tests
Change in haemoglobin
时间窗: 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
Value of haemoglobin (g/dL) in blood tests
Significant cardiovascular and non-cardiovascular adverse effects during treatment.
时间窗: Date of the event throughout the study.
number of participants with significant cardiovascular and non-cardiovascular adverse effects throughout the study, threatening life, requiring admission, prolonging hospitalization, being clinically relevant or causing chemotherapy interruptions.
次要结局
- Change in health-related quality of life assessed by the Functional Assessment of Cancer Therapy - Breast plus Arm Morbidity (FACT-B+4) questionnaire.(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.(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).(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).(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(Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2))
- Changes in peak expiratory flow(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).(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.(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(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.(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).(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.(Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2))
- Change in physical activity assessed by the score in the Godin Leisure Test Exercise Questionnaire (GLTEQ).(Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2).)
- Change in cardiovascular treatment by its presence or absence.(Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2).)
研究者
Carlos Peña Gil
Head of Cardiac Rehabilitation Unit
Hospital Clinico Universitario de Santiago