Идёт набор NCT06302634

Cardio-Oncology Rehabilitation Care Process

— Наблюдательное Cardio-Oncology Rehabilitation Cardiovascular Diseases Exercise

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Exercise-based cardio-oncology rehabilitation.
Кому может быть актуально: Состояния в реестре: Cardio-Oncology, Rehabilitation, Cardiovascular Diseases, Exercise. Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Испания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Hospital-based Cardio-Oncology Rehabilitation Care Process for Cardiovascular Health in Cancer Patients

Обзор

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).

Подробное описание

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.

Вмешательства

Другое 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.

Первичные конечные точки

Change in left ventricular systolic function quantified by left ventricular ejection fraction and global longitudinal strain by transthoracic echocardiography [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: Date of the event throughout the study.]

Вторичные конечные точки (12)

Change in health-related quality of life assessed by the Functional Assessment of Cancer Therapy - Breast plus Arm Morbidity (FACT-B+4) questionnaire. [Срок оценки: 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. [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: 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 [Срок оценки: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)]
Changes in peak expiratory flow [Срок оценки: 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). [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 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). [Срок оценки: 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. [Срок оценки: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)]

Критерии участия

Критерии включения

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.