Cardio-Oncology Rehabilitation Care Process

Cardiovascular Diseases Clinical Trial

— ReCO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06302634
• Other study ID #: ReCO
• Secondary ID: 2022/137
• Status: Recruiting
• Start date: June 22, 2022
• Est. completion date: June 22, 2027

Study information

• Verified date: March 2024
• Source: Hospital Clinico Universitario de Santiago
• Contact: Estíbaliz Díaz-Balboa, PT
• Phone: +34 981950747
• Email: estibaliz.diaz.balboa[@]sergas.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 22, 2027
• Est. primary completion date: June 22, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardio-Oncology
• Cardiovascular Diseases
• Exercise
• Neoplasms
• Rehabilitation

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario de Santiago	Santiago de Compostela	A Coruña

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinico Universitario de Santiago

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence and compliance to cardiac rehabilitation program (CBCORe) assessed by number of training sessions attended/number of sessions planned.	Number of training sessions attended / number of sessions planned.	At the end of the cardiac rehabilitation program (3 months duration).
Other	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.	Number of telephone calls attended / number of telephone calls planned.	At the end of the cardiac rehabilitation program (3 months duration).
Other	Security of the cardiac rehabilitation program assessed by number of adverse events during training (CBCORe).	Adverse events during training.	At the end of the cardiac rehabilitation program (3 months duration).
Other	Satisfaction with the CORe program	Global satisfaction is scored from 0 (no benefit) to 10 (highest benefit); and evaluated with an open-ended question, how do you expect to benefit from participating in the program?	At the end of the cardiac rehabilitation program (3 months duration).
Other	Follow-up of the exercise performed after participation in the CORe program	Question (yes/no): do you continue exercising? supervized? if supervized, is it individualized by a physiotherapist? individualized by a personal trainer? recommendations from a technician in a gym? or city council group activities?	At follow-up at 9 months from baseline (T2).
Other	Presence or absence of lymphoedema.	It is considered 2 cm difference between upper limbs. Measurement is performed at the base of the 3rd finger, hand, wrist, 10 cm above the wrist, elbow, 10 cm above the elbow and axilla.	Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2).
Primary	Change in left ventricular systolic function quantified by left ventricular ejection fraction and global longitudinal strain by transthoracic echocardiography	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	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
Primary	Increased cardiac biomarkers (Troponin I and BNP/NT-proBNP)	cTnI/T>percentil 99, BNP=35 pg/mL, NT-proBNP=125 pg/mL	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
Primary	Decrease in functional capacity assessed by estimated VO2peak	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	Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Primary	Change in cardiovascular risk profile as assessed by the presence or absence of classic cardiovascular risk factors.	Dyslipidemia, Diabetes mellitus, Arterial Hypertension, Smoking status	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
Primary	Changes in fasting blood glucose	Value of fasting blood glucose (mg/dL) in blood tests	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
Primary	Changes in total low-density lipoprotein (LDL) and total cholesterol (TC) levels	Value of LDL >160 mg/dL or CT> 200 mg/dL in blood tests	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
Primary	Change in haemoglobin	Value of haemoglobin (g/dL) in blood tests	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
Primary	Significant cardiovascular and non-cardiovascular adverse effects during treatment.	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.	Date of the event throughout the study.
Secondary	Change in health-related quality of life assessed by the Functional Assessment of Cancer Therapy - Breast plus Arm Morbidity (FACT-B+4) questionnaire.	Score achieved in the Functional Assessment of Cancer Therapy - Breast plus Arm Morbidity (FACT-B+4) questionnaire, a specific validated scale to assess quality of life of women with breast cancer. It comprises 27 items within 5 areas of assessment: physical well-being (7 items), social and family environment (7 items), emotional well-being (7 items), functional well-being (6 items) and worries related to the diagnosis and treatment of the disease (9 items). Each item is scored by means of a Likert scale from 0 to 5, with higher scores representing better results. The total score is obtained by adding the scores for each item, and ranges from a minimum of 0 (worst possible result) to a maximum of 146 (best possible result).	Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Secondary	Change in localized lower limb functional capacity assessed by number of repetitions performed within 30 seconds in the sit-to-stand test.	Number of repetitions in the sit-to-stand test within 30 seconds.	Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Secondary	Change in lower limb strength measured by squat dynamometry (kg).	Kilograms by dynamometry.	Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Secondary	Change in biceps strength by dynamometry (kg).	Kilograms by dynamometry.	Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Secondary	Change in perimeter (cm) of the right thigh 5cm above the upper edge of the patella	Thigh perimeter measured with a tape measure in cm.	Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Secondary	Changes in peak expiratory flow	The peak expiratory flow in units of liters per minute (L/min), measured with a peak flow meter.	Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Secondary	Change in upper limb strength measured by dynamometry (kg).	Grip strength (both right and left side) and bilateral biceps strength in kilograms by dynamometry.	Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Secondary	Change in anthropometric parameters: weight in kg.	Weight measured in kg.	Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Secondary	Change in anthropometric parameters: Body mass index (BMI) in kg/m^2	Weight and height will be combined to report BMI in kg/m^2	Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Secondary	Change in anthropometric parameters: abdominal circumference in cm.	Abdominal perimeter measured with a tape measure in cm.	Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Secondary	Change in resting heart rate measured by pulse oximetry (beats per min).	Resting heart rate by pulse oximetry (beats per min).	Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Secondary	Change in resting blood pressure (mmHg) measured by a blood pressure monitor.	Resting blood pressure by a blood pressure monitor in mmHg.	Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Secondary	Change in physical activity assessed by the score in the Godin Leisure Test Exercise Questionnaire (GLTEQ).	Score achieved in the Godin Leisure Test Exercise Questionnaire (GLTEQ) for quantification of physical activity. Activities are classified into three subgroups: "strenuous," "moderate," and "light." The scores corresponding to the energy expenditure (metabolic equivalent (MET)) are obtained by multiplying activities performed for more than 15 min in a week with their coefficients. The numbers represent the MET intensity values (strenuous/ exhausting exercises: 9 METs, moderate exercises: 5 METs, and light exercises: 3 METs).The increasing scores are associated with the increasing number of exercise behaviors, providing references about the contribution of physical activity to health: the activity score of 24 units and more as active (substantial benefits); the activity score of 14-23 units as moderately active (some benefits); and the activity score of 13 units and less as inactive (less substantial or low benefits).	Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2).
Secondary	Change in cardiovascular treatment by its presence or absence.	ACE Inhibitor/ARB II; Beta-blocker; Statins; Ezetimibe	Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2).