Cardio-Oncology Rehabilitation Care Process

NCT06302634 | Recruiting

• 2 other identifiers: ReCO2022/137
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardio-Oncology; Rehabilitation; Cardiovascular Diseases; Exercise

Keywords

cardio-oncology rehabilitation; cardiovascular prevention; exercise; cancer

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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)

• 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

• 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

• 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

• 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

• 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 Outcomes (14)

• 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)

Other Outcomes (6)

• Adherence and compliance to cardiac rehabilitation program (CBCORe) assessed by number of training sessions attended/number of sessions planned.

  At the end of the cardiac rehabilitation program (3 months duration).

• 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.

  At the end of the cardiac rehabilitation program (3 months duration).

• Security of the cardiac rehabilitation program assessed by number of adverse events during training (CBCORe).

  At the end of the cardiac rehabilitation program (3 months duration).

Study Arms (2)

Center-Based Cardio-Oncology Rehabilitation (CBCORe)

Therapeutic exercise program supervised by a physiotherapist. 2 days/week, duration 1h, in the Cardiac Rehabilitation ward.

Other: Exercise-based cardio-oncology rehabilitation

Home-Based Cardio-Oncology Rehabilitation (HBCORe)

Recommendation of physical exercise and motivational interview through telephone follow-up every 2 weeks by the physiotherapist.

Other: Exercise-based cardio-oncology rehabilitation

Interventions

Exercise-based cardio-oncology rehabilitation OTHER

Within the multidisciplinary approach of cardio-oncology rehabilitation, the exercise program will include recommendation and supervision of strength, aerobic and mobility exercises.

Center-Based Cardio-Oncology Rehabilitation (CBCORe); Home-Based Cardio-Oncology Rehabilitation (HBCORe)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with breast cancer at high risk of developing cardiotoxicity

You may qualify if:

• 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.

You may not qualify if:

• Patients with physical or mental limitation to carry out an exercise program.

Sponsors & Collaborators

• Hospital Clinico Universitario de Santiago: lead

Study Sites (1)

Hospital Clínico Universitario de Santiago

Santiago de Compostela, A Coruña, 15706, Spain

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Motor Activity; Neoplasms

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Carlos Peña-Gil, MD, PhD

  Hospital Clinico Universitario de Santiago

  STUDY DIRECTOR

• Violeta González-Salvado, MD, PhD

  Hospital Clinico Universitario de Santiago

  STUDY CHAIR

Central Study Contacts

Estíbaliz Díaz-Balboa, PT

CONTACT

+34 981950747; estibaliz.diaz.balboa@sergas.es

Bibiana Villamayor-Blanco, MD, PhD

CONTACT

+ 34 981950744; bibiana.villamayor.blanco@sergas.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cardiac Rehabilitation Unit

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: June 22, 2022
• Primary Completion (Estimated): June 22, 2027
• Study Completion (Estimated): June 22, 2027
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

ES (1)