Cardio-Oncology Rehabilitation Care Process

NCT ID: NCT06302634

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-22
• Study Completion Date: 2027-06-22

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.

Conditions

Cardio-Oncology; Rehabilitation; Cardiovascular Diseases; Exercise

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Center-Based Cardio-Oncology Rehabilitation (CBCORe)

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

Exercise-based cardio-oncology rehabilitation

Intervention Type: OTHER

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

Home-Based Cardio-Oncology Rehabilitation (HBCORe)

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

Exercise-based cardio-oncology rehabilitation

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinico Universitario de Santiago

OTHER

Sponsor Role: lead

Responsible Party

Carlos Peña Gil

Head of Cardiac Rehabilitation Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlos Peña-Gil, MD, PhD

Role: STUDY_DIRECTOR

Hospital Clinico Universitario de Santiago

Violeta González-Salvado, MD, PhD

Role: STUDY_CHAIR

Hospital Clinico Universitario de Santiago

Locations

Hospital Clínico Universitario de Santiago

Santiago de Compostela, A Coruña, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Estíbaliz Díaz-Balboa, PT

Role: CONTACT

estibaliz.diaz.balboa@sergas.es

+34 981950747

Bibiana Villamayor-Blanco, MD, PhD

Role: CONTACT

bibiana.villamayor.blanco@sergas.es

+ 34 981950744

Facility Contacts

Carlos Peña-Gil, MD, PhD

Role: primary

carlos.pena.gil@sergas.es

+34 981 950 778

Estíbaliz Díaz-Balboa

Role: backup

estibaliz.diaz.balboa@sergas.es

+34 981950747

Other Identifiers

2022/137

Identifier Type: OTHER

Identifier Source: secondary_id

ReCO

Identifier Type: -

Identifier Source: org_study_id