Multidisciplinary Team IntervenTion in CArdio-ONcology (TITAN Study)

Study Overview
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Brief Summary
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People with breast cancer often experience many short and long-term side effects as a result of both the cancer and the necessary treatments. Receiving extra assessments and care from teams of multiple health professionals has been shown to be helpful for people with other health problems, such as heart disease. These 'multidisciplinary' teams may include nurses, doctors, pharmacists, dietitians, exercise therapists, counselors, and other specialists. Currently, the investigators do not know if receiving extra assessments from a multidisciplinary team is helpful for people receiving cancer treatment. In this study, the investigators hope to learn the effect of extra assessments and early interventions from teams of health care professionals in people diagnosed with cancer, during and after the treatment period. After initial assessments, participants will be randomized to multidisciplinary team intervention or usual care.

Official Title
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Multidisciplinary Team IntervenTion in CArdio-ONcology

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Multidisciplinary team intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically confirmed malignancy (breast or lymphoma); scheduled to receive anthracycline and/or trastuzumab-based chemotherapy; age ≥ 18 years; willing to attend follow-up visits. Exclusion Criteria: physical disability preventing exercise testing or DEXA scan; psychiatric disease or disorder precluding informed consent; participation in other cardiotoxicity or exercise intervention study; contraindication to anti-cancer therapy, including known heart failure, cardiomyopathy, or baseline LVEF < 50%; previous anthracycline or trastuzumab-based therapy; previous radiotherapy to thorax.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Supportive care intervention
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: multidisciplinary team intervention<br>Intervention arm receives regular assessments and treatments from cardiology team, clinical nutrition, pharmacist, exercise physiologist and physiotherapist | Behavioral: Multidisciplinary team intervention<br>* Intervention arm receives regular assessments and treatments from cardiology team, clinical nutrition, pharmacist, exercise physiologist and physiotherapist<br>* Other names: physiotherapy assessment and training;|
| No Intervention: Observational arm<br>Participants randomized to observational arm will receive usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac MRI | left ventricular ejection fraction (LVEF) | change from baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum biomarkers | percent change in established biomarkers (troponin, BNP) | change from baseline to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multidisciplinary team, exercise, nutrition, cardiology, physiotherapy, imaging