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Multidisciplinary Team IntervenTion in CArdio-ONcology (TITAN Study)

Phase 2
Active, not recruiting
Conditions
Breast Cancer
Interventions
Behavioral: Multidisciplinary team intervention
Registration Number
NCT01621659
Lead Sponsor
University of Alberta
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
80
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
multidisciplinary team interventionMultidisciplinary team interventionIntervention arm receives regular assessments and treatments from cardiology team, clinical nutrition, pharmacist, exercise physiologist and physiotherapist
Primary Outcome Measures
NameTimeMethod
cardiac MRIchange from baseline to 12 months

left ventricular ejection fraction (LVEF)

Secondary Outcome Measures
NameTimeMethod
serum biomarkerschange from baseline to 12 months

percent change in established biomarkers (troponin, BNP)

Trial Locations

Locations (1)

Cross Cancer Institute

🇨🇦

Edmonton, Alberta, Canada

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