- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01621659
Multidisciplinary Team IntervenTion in CArdio-ONcology (TITAN Study) (TITAN)
Multidisciplinary Team IntervenTion in CArdio-ONcology
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: multidisciplinary team intervention
Intervention arm receives regular assessments and treatments from cardiology team, clinical nutrition, pharmacist, exercise physiologist and physiotherapist
|
Intervention arm receives regular assessments and treatments from cardiology team, clinical nutrition, pharmacist, exercise physiologist and physiotherapist
Other Names:
|
|
No Intervention: Observational arm
Participants randomized to observational arm will receive usual care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cardiac MRI
Time Frame: change from baseline to 12 months
|
left ventricular ejection fraction (LVEF)
|
change from baseline to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
serum biomarkers
Time Frame: change from baseline to 12 months
|
percent change in established biomarkers (troponin, BNP)
|
change from baseline to 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
multidisciplinary team interventions
Time Frame: change from baseline to 12 months
|
nutrition, exercise, physiotherapy interventions
|
change from baseline to 12 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Pituskin E, Haykowsky M, McNeely M, Mackey J, Chua N, Paterson I. Rationale and design of the multidisciplinary team IntervenTion in cArdio-oNcology study (TITAN). BMC Cancer. 2016 Sep 15;16(1):733. doi: 10.1186/s12885-016-2761-8.
- Kirkham AA, Mackey JR, Thompson RB, Haykowsky MJ, Oudit GY, McNeely M, Coulden R, Stickland MK, Baracos VE, Dyck JRB, Haennel R, Pituskin E, Paterson DI. TITAN Trial: A Randomized Controlled Trial of a Cardiac Rehabilitation Care Model in Breast Cancer. JACC Adv. 2023 Jul 27;2(6):100424. doi: 10.1016/j.jacadv.2023.100424. eCollection 2023 Aug.
- Maayah ZH, Ferdaoussi M, Boukouris AE, Takahara S, Das SK, Khairy M, Mackey JR, Pituskin E, Sutendra G, Paterson DI, Dyck JRB. Endothelin Receptor Blocker Reverses Breast Cancer-Induced Cardiac Remodeling. JACC CardioOncol. 2023 May 2;5(5):686-700. doi: 10.1016/j.jaccao.2023.02.004. eCollection 2023 Oct.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Skin Diseases
- Breast Diseases
- Behavior
- Skin and Connective Tissue Diseases
- Breast Neoplasms
- Motor Activity
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Health Services
- Health Care Facilities Workforce and Services
- Community Health Services
- Behavioral Disciplines and Activities
- Mental Health Services
- Epidemiologic Measurements
- Methods
- Nutrition Assessment
- Counseling
Other Study ID Numbers
- TITAN 102
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