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Multidisciplinary Team IntervenTion in CArdio-ONcology (TITAN Study) (TITAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01621659
Recruitment Status : Active, not recruiting
First Posted : June 18, 2012
Last Update Posted : July 19, 2023
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Study Description
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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.


Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Multidisciplinary team intervention Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Supportive care intervention
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Multidisciplinary Team IntervenTion in CArdio-ONcology
Study Start Date : May 2014
Actual Primary Completion Date : May 30, 2018
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: multidisciplinary team intervention
Intervention arm receives regular assessments and treatments from cardiology team, clinical nutrition, pharmacist, exercise physiologist and physiotherapist
 Behavioral: Multidisciplinary team intervention
Intervention arm receives regular assessments and treatments from cardiology team, clinical nutrition, pharmacist, exercise physiologist and physiotherapist
Other Names:
  • cardiology assessment and intervention
  • nutritional assessment and intervention
  • exercise assessment and training
  • pharmacist assessment and counseling
  • physiotherapy assessment and training
No Intervention: Observational arm
Participants randomized to observational arm will receive usual care.


Outcome Measures
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Primary Outcome Measures :
  1. cardiac MRI [ Time Frame: change from baseline to 12 months ]
    left ventricular ejection fraction (LVEF)


Secondary Outcome Measures :
  1. serum biomarkers [ Time Frame: change from baseline to 12 months ]
    percent change in established biomarkers (troponin, BNP)


Other Outcome Measures:
  1. multidisciplinary team interventions [ Time Frame: change from baseline to 12 months ]
    nutrition, exercise, physiotherapy interventions


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621659


Locations
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Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
University of Alberta
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01621659    
Other Study ID Numbers: TITAN 102
First Posted: June 18, 2012    Key Record Dates
Last Update Posted: July 19, 2023
Last Verified: July 2023
Keywords provided by University of Alberta:
multidisciplinary team
exercise
nutrition
 cardiology
physiotherapy
imaging