Multidisciplinary Team IntervenTion in CArdio-ONcology (TITAN Study) (TITAN)
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ClinicalTrials.gov Identifier: NCT01621659 |
Recruitment Status :
Active, not recruiting
First Posted : June 18, 2012
Last Update Posted : July 19, 2023
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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.
Condition or disease | Intervention/treatment | Phase |
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Breast Cancer | Behavioral: Multidisciplinary team intervention | Phase 2 |
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 |
Arm | Intervention/treatment |
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Experimental: multidisciplinary team intervention
Intervention arm receives regular assessments and treatments from cardiology team, clinical nutrition, pharmacist, exercise physiologist and physiotherapist
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Behavioral: Multidisciplinary team intervention
Intervention arm receives regular assessments and treatments from cardiology team, clinical nutrition, pharmacist, exercise physiologist and physiotherapist
Other Names:
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No Intervention: Observational arm
Participants randomized to observational arm will receive usual care.
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- cardiac MRI [ Time Frame: change from baseline to 12 months ]left ventricular ejection fraction (LVEF)
- serum biomarkers [ Time Frame: change from baseline to 12 months ]percent change in established biomarkers (troponin, BNP)
- multidisciplinary team interventions [ Time Frame: change from baseline to 12 months ]nutrition, exercise, physiotherapy interventions
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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
Canada, Alberta | |
Cross Cancer Institute | |
Edmonton, Alberta, Canada, T6G 1Z2 |
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 |
multidisciplinary team exercise nutrition |
cardiology physiotherapy imaging |