Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors

NCT ID: NCT05132998

Last Updated: 2022-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2022-07-05

Brief Summary

Many cancer survivors are at risk for cardiovascular disease (CVD); it is therefore important to identify patients at increased risk for cardiotoxicity, especially in the setting of CVRF or pre-existing CVD, and to design personalized interventions to prevent cardiovascular morbidity. In this background, cardio-oncology rehabilitation frameworks for specific cancer patients have been proposed. Given potential beneficial effects of exercise among cancer patients (including those at higher risk of CVD), data pertaining to optimal program designs are of paramount contemporary importance.

Thus, the aim of this study is to compare the impact of a Cardiac Rehabilitation Program (CRP) model versus a community-based exercise intervention plus usual care on cardiorespiratory fitness (CRF), physical function domains and CVRF control in adult cancer survivors who have been exposed to cardiotoxic cancer treatment and/or with cardiovascular medical background. Study outcomes will be assessed at baseline (M0) and after an 8 weeks-intervention (M1), comprising maximal aerobic capacity (peak oxygen uptake), muscular strength, neuromuscular function, single CVRF control including physical activity measurements and psychosocial parameters, health-related quality of life, fatigue, health literacy, inflammatory response and feasibility metrics; an economic evaluation will provide quantitative comparison, for a cost-effectiveness analysis

Conditions

Oncologic Disorders; Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cardiac Rehabilitation Program (CRP) Group

1. Baseline consultation with physiatrist specialized in CRP - addressing CVRF control, comorbidities and disabilities; case-by-case discussion with a cardiologist specialized in CR will be undertaken, for tailoring exercise prescription. Nutritional individualized plan addressing dietary goals. Psychological management addressing psychosocial outcomes and motivation for healthy lifestyle habits

2. Multidisciplinary team educational meeting: periodic group sessions with health education purposes

3. Exercise intervention - 2 times/week sessions at CR facilities, supervised by a physiatrist, conducted by physiotherapist. Heart rate (HR) continuously monitored during each session by remote electrocardiographic monitoring or HR monitor. Exercise intensity estimated according to CR guidelines, determined after CV risk stratification, using CPET results.

Group Type: EXPERIMENTAL

Cardiac Rehabilitation Program

Intervention Type: OTHER

In addition to standard medical care, for an 8-week period, patients will have access to the core components of a CRP, delivered by a multidisciplinary rehabilitation team

Community Exercise Group

a) Besides standard medical and supportive care, psychological and nutritional individual support will be offered on demand, in hospital setting, according to the attending physician standard clinical assessment and usual care.

Exercise intervention - Performed at a community-based facility, comprising 2 sessions/week, prescribed according to current physical activity guidelines for cancer survivors. Exercise intervention will be conducted by an exercise physiologist, internationally certified in exercise for cancer patients

Group Type: ACTIVE_COMPARATOR

Community exercise intervention

Intervention Type: OTHER

In addition to standard medical care, for an 8-week period, patients will have access to a community exercise intervention oriented by a sports professional

Interventions

Cardiac Rehabilitation Program

In addition to standard medical care, for an 8-week period, patients will have access to the core components of a CRP, delivered by a multidisciplinary rehabilitation team

Intervention Type: OTHER

Community exercise intervention

In addition to standard medical care, for an 8-week period, patients will have access to a community exercise intervention oriented by a sports professional

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age >18 years
• Cancer survivors exposed to the following therapies:

• high-dose anthracycline or high dose radiotherapy in thoracic wall
• low-dose anthracycline or anti-human Epidermal growth factor Receptor-type 2 drugs (anti-HER2) alone plus ≥ 2 CVRF and / or age ≥ 60 years at cancer treatment
• low-dose anthracycline followed by anti-HER2;
• Cancer survivors with medical background of

• coronary artery disease
• moderate valvular disease
• LVEF <50%
• Follow up after primary treatment with curative intent
• Conclusion of primary treatment at least 2 months before the inclusion

Exclusion Criteria

• Previous participation in a CRP
• Contraindications to exercise training:

• musculoskeletal or neurologic disorders, cognitive impairment
• unstable angor pectoris, decompensated HF, active myocarditis, acute endocarditis, acute pulmonary thromboembolism, complex ventricular arrhythmias
• Active cancer
• Considered unsuitable as per principal investigator judgment (namely due to expected inability to fulfill proposed schedule)

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

Sponsors

Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

OTHER_GOV

Sponsor Role: collaborator

University Institute of Maia

OTHER

Sponsor Role: collaborator

Associacao de Investigacao de Cuidados de Suporte em Oncologia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centro Hospitalar Vila Nova de Gaia Espinho, E.P.E.

Vila Nova de Gaia, Porto District, Portugal

Countries

Portugal

References

Viamonte SG, Joaquim AV, Alves AJ, Vilela E, Capela A, Ferreira C, Duarte BF, Rato ND, Teixeira MP, Tavares A, Santos M, Ribeiro F. Cardio-Oncology Rehabilitation for Cancer Survivors With High Cardiovascular Risk: A Randomized Clinical Trial. JAMA Cardiol. 2023 Dec 1;8(12):1119-1128. doi: 10.1001/jamacardio.2023.3558.

Reference Type: DERIVED

PMID: 37819656 (View on PubMed)

Other Identifiers

CORE Trial

Identifier Type: -

Identifier Source: org_study_id