Multidisciplinary Team IntervenTion in CArdio-ONcology (TITAN Study)

Breast Cancer Clinical Trial

— TITAN  

Official title:

Multidisciplinary Team IntervenTion in CArdio-ONcology

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01621659
• Other study ID #: TITAN 102
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 2014
• Est. completion date: June 30, 2025

Study information

• Verified date: July 2023
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: June 30, 2025
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Behavioral:
• Multidisciplinary team intervention
Intervention arm receives regular assessments and treatments from cardiology team, clinical nutrition, pharmacist, exercise physiologist and physiotherapist

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	multidisciplinary team interventions	nutrition, exercise, physiotherapy interventions	change from baseline to 12 months
Primary	cardiac MRI	left ventricular ejection fraction (LVEF)	change from baseline to 12 months
Secondary	serum biomarkers	percent change in established biomarkers (troponin, BNP)	change from baseline to 12 months