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OpenTrials
Completed

NCT Number: NCT05132998

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

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

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Key information

Conditions

Oncologic Disorders Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Vila Nova de Gaia, Porto District, 4434-502, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cardiac rehabilitation program

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 intervention

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

Primary outcomes

  1. Cardiorespiratory fitness

    Time frame: Change from baseline to 2 months

    VO2peak measured by CPET

Secondary outcomes

  1. Ventilatory efficiency

    Time frame: Change from baseline to 2 months

    minute ventilation to carbon dioxide production slope (VE/VCO2 slope) assessed by CPET

  2. Sit-to-stand test

    Time frame: Change from baseline to 2 months

    Sit-to-stand test during 60 seconds

  3. Handgrip maximal isometric muscle strength

    Time frame: Change from baseline to 2 months

    muscle strength measured with manual dynamometers (Kgf)

  4. Body composition

    Time frame: Change from baseline to 2 months

    Changes in body composition assessed by bioelectrical impedance analysis

  5. Resting diastolic blood pressure

    Time frame: Change from baseline to 2 months

    Measured with an average of 3 readings by an automated measurement device as per the ESC guidelines (mmHg)

  6. Resting systolic blood pressure

    Time frame: Change from baseline to 2 months

    Measured with an average of 3 readings by an automated measurement device as per the ESC guidelines (mmHg)

  7. Resting heart rate

    Time frame: Change from baseline to 2 months

    Measured with an average of 3 readings by an automated measurement device (bpm)

  8. Hyperlipidemia

    Time frame: Change from baseline to 2 months

    Measured through fasting Blood biochemistry including total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), high-density-lipoprotein cholesterol (HDL-C), triglycerides (TG)

  9. Diabetes control

    Time frame: Change from baseline to 2 months

    Measured through glycated haemoglobin (%) in fasting state

  10. Physical Activity

    Time frame: Change from baseline to 2 months

    Self-reported through the International Physical Activity Questionnaire, classifying the activity in three categories (low activity levels, moderate activity levels or high activity levels)

  11. Physical Activity

    Time frame: Change from baseline to 2 months

    objectively assessed by accelerometer, to wear for seven consecutive days

  12. Smoking Cessation

    Time frame: Change from baseline to 2 months

    Cigarette smoking habits quantified in pack-year and cigarettes per day, to measure exposure to tobacco

  13. Depression and anxiety

    Time frame: Change from baseline to 2 months

    Psychosocial parameters assessed through the Hospital Anxiety and Depression Score questionnaire. Scores 0-14. A sub-scale score > 8 denotes anxiety or depression symptoms

  14. Health Related Quality of Life

    Time frame: Change from baseline to 2 months

    Evaluated using the EuroQuol Five- Dimensional questionnaire ( EQ-5D-5L). It consists in five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ - Visual Analog Scale records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.

  15. Fatigue

    Time frame: Change from baseline to 2 months

    Fatigue score evaluated by the specific item on the EORTC QLQ-C30 questionnaire (high score representing high level of symptomatology)

  16. Health Literacy

    Time frame: Change from baseline to 2 months

    Assessed by the Newest Vital Sign questionnaire; range score 0-6 (high score corresponding to high health literacy)

  17. Inflammatory markers- Interleukin-6 (IL-6)

    Time frame: Change from baseline to 2 months

    Blood samples collected to access plasma levels of IL-6

  18. Inflammatory markers - High-sensitivity C-reactive protein

    Time frame: Change from baseline to 2 months

    Blood samples collected to access plasma levels of high-sensitivity C-reactive protein

  19. Feasibility - Consent rate

    Time frame: Through study recruitment, up to 2 years

    number of patients who met inclusion criteria divided by the number who consented in writing to participate. Reasons for not participating in the study will be registered.

  20. Testing and Intervention Adverse events

    Time frame: Change from baseline to 2 months

    all the events will be recorded and registered as "related" or "unrelated" to the intervention itself, as well as the impact for exercise concerns or other health intervention required

  21. Feasibility - Retention rate

    Time frame: Change from baseline to 2 months

    number of participants who remained in the study (without formally drop out during intervention).

  22. Feasibility - Intervention adherence

    Time frame: Change from baseline to 2 months

    total number of exercise sessions attended by participants allocated to this intervention group. Reasons for dropping out will be registered.

  23. Feasibility - Completion rate

    Time frame: Change from baseline to 2 months

    number of patients that completed all the evaluations during the defined timeline.

  24. Cost-effectiveness analysis

    Time frame: From baseline assessment up to 2 years

    Incremental cost per quality-adjusted life. Costs will be calculated from the provider perspective, which includes the costs incurred by the health institution providing health services; and from the societal perspective

Sponsors and collaborators

Lead sponsor

Associacao de Investigacao de Cuidados de Suporte em Oncologia

Other

Collaborators

  • Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
  • University Institute of Maia

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 24, 2021
Registry last updated
Oct 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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