Clinical trial NCT06302634: Cardio-Oncology Rehabilitation Care Process
Official title: Hospital-based Cardio-Oncology Rehabilitation Care Process for Cardiovascular Health in Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardio-Oncology
Rehabilitation
Cardiovascular Diseases
Exercise
Keywords: cardio-oncology rehabilitation; cardiovascular prevention; exercise; cancer
Lead sponsor: Hospital Clinico Universitario de Santiago
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with breast cancer at high risk of developing cardiotoxicity

Brief summary: 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.

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.

Primary outcomes:
measure: Change in left ventricular systolic function quantified by left ventricular ejection fraction and global longitudinal strain by transthoracic echocardiography
timeFrame: 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
measure: Increased cardiac biomarkers (Troponin I and BNP/NT-proBNP)
timeFrame: 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
measure: Decrease in functional capacity assessed by estimated VO2peak
timeFrame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
measure: Change in cardiovascular risk profile as assessed by the presence or absence of classic cardiovascular risk factors.
timeFrame: 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
measure: Changes in fasting blood glucose
timeFrame: 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
measure: Changes in total low-density lipoprotein (LDL) and total cholesterol (TC) levels
timeFrame: 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
measure: Change in haemoglobin
timeFrame: 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
measure: Significant cardiovascular and non-cardiovascular adverse effects during treatment.
timeFrame: Date of the event throughout the study.
Secondary outcomes:
measure: Change in health-related quality of life assessed by the Functional Assessment of Cancer Therapy - Breast plus Arm Morbidity (FACT-B+4) questionnaire.
timeFrame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
measure: Change in localized lower limb functional capacity assessed by number of repetitions performed within 30 seconds in the sit-to-stand test.
timeFrame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
measure: Change in lower limb strength measured by squat dynamometry (kg).
timeFrame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
measure: Change in biceps strength by dynamometry (kg).
timeFrame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
measure: Change in perimeter (cm) of the right thigh 5cm above the upper edge of the patella
timeFrame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
measure: Changes in peak expiratory flow
timeFrame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
measure: Change in upper limb strength measured by dynamometry (kg).
timeFrame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
measure: Change in anthropometric parameters: weight in kg.
timeFrame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
measure: Change in anthropometric parameters: Body mass index (BMI) in kg/m^2
timeFrame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
measure: Change in anthropometric parameters: abdominal circumference in cm.
timeFrame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
measure: Change in resting heart rate measured by pulse oximetry (beats per min).
timeFrame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
measure: Change in resting blood pressure (mmHg) measured by a blood pressure monitor.
timeFrame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
measure: Change in physical activity assessed by the score in the Godin Leisure Test Exercise Questionnaire (GLTEQ).
timeFrame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2).
measure: Change in cardiovascular treatment by its presence or absence.
timeFrame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2).
Other outcomes:
measure: Adherence and compliance to cardiac rehabilitation program (CBCORe) assessed by number of training sessions attended/number of sessions planned.
timeFrame: At the end of the cardiac rehabilitation program (3 months duration).
measure: Compliance to home-based cardiac rehabilitation program (HBCORe) assessed by the total number of telephone calls during the Physiotherapy follow-up and the total time of telephone calls.
timeFrame: At the end of the cardiac rehabilitation program (3 months duration).
measure: Security of the cardiac rehabilitation program assessed by number of adverse events during training (CBCORe).
timeFrame: At the end of the cardiac rehabilitation program (3 months duration).
measure: Satisfaction with the CORe program
timeFrame: At the end of the cardiac rehabilitation program (3 months duration).
measure: Follow-up of the exercise performed after participation in the CORe program
timeFrame: At follow-up at 9 months from baseline (T2).
measure: Presence or absence of lymphoedema.
timeFrame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2).
Locations:
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago
state: A Coruña
Study officials:
affiliation: Hospital Clinico Universitario de Santiago
name: Carlos Peña-Gil, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Clinico Universitario de Santiago
name: Violeta González-Salvado, MD, PhD
role: STUDY_CHAIR
References: