Cardio-Oncology Rehabilitation Care Process
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorHospital Clinico Universitario de Santiago
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients with physical or mental limitation to carry out an exercise program.
Trial population
Women with breast cancer at high risk of developing cardiotoxicity
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Exercise-based cardio-oncology rehabilitation
Other interventionWithin the multidisciplinary approach of cardio-oncology rehabilitation, the exercise program will include recommendation and supervision of strength, aerobic and mobility exercises.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Center-Based Cardio-Oncology Rehabilitation (CBCORe)1 intervention
Group B: Home-Based Cardio-Oncology Rehabilitation (HBCORe)1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
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 years2
Increased cardiac biomarkers (Troponin I and BNP/NT-proBNP)
cTnI/T\>percentil 99, BNP≥35 pg/mL, NT-proBNP≥125 pg/mL
Time frame
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 years3
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
Time frame
Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)4
Change in cardiovascular risk profile as assessed by the presence or absence of classic cardiovascular risk factors.
Dyslipidemia, Diabetes mellitus, Arterial Hypertension, Smoking status
Time frame
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 yearsSecondary outcomes
1
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).
Time frame
Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)2
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.
Time frame
Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)3
Change in lower limb strength measured by squat dynamometry (kg).
Kilograms by dynamometry.
Time frame
Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)4
Change in biceps strength by dynamometry (kg).
Kilograms by dynamometry.
Time frame
Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)Other outcomes
1
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.
Time frame
At the end of the cardiac rehabilitation program (3 months duration).2
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.
Time frame
At the end of the cardiac rehabilitation program (3 months duration).3
Security of the cardiac rehabilitation program assessed by number of adverse events during training (CBCORe).
Adverse events during training.
Time frame
At the end of the cardiac rehabilitation program (3 months duration).4
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?
Time frame
At the end of the cardiac rehabilitation program (3 months duration).Sponsors and contacts
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Source ClinicalTrials.gov