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

Associacao de Investigacao de Cuidados de Suporte em Oncologia

Status: Completed

Conditions: Cardiovascular Diseases; Oncologic Disorders

Treatments: Other: Cardiac Rehabilitation Program; Other: Community exercise intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05132998

CORE Trial

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Cardiac Rehabilitation Program (CRP) Group

Experimental group

Description:

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.

Treatment:

Other: Cardiac Rehabilitation Program

Community Exercise Group

Active Comparator group

Description:

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

Treatment:

Other: Community exercise intervention