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

• ClinicalTrials.gov Identifier: NCT01621659
• Recruitment Status: Active, not recruiting
• First Posted: June 18, 2012
• Last Update Posted: July 19, 2023
• Sponsor: University of Alberta
• Information provided by (Responsible Party): University of Alberta

Tracking Information

• First Submitted Date: June 4, 2012
• First Posted Date: June 18, 2012
• Last Update Posted Date: July 19, 2023
• Study Start Date: May 2014
• Actual Primary Completion Date: May 30, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 8, 2020)

cardiac MRI [ Time Frame: change from baseline to 12 months ]

left ventricular ejection fraction (LVEF)

Original Primary Outcome Measures (submitted: June 13, 2012)

echocardiography [ Time Frame: change from baseline to 12 months ]

percentage of longitudinal strain from baseline

Current Secondary Outcome Measures (submitted: June 13, 2012)

serum biomarkers [ Time Frame: change from baseline to 12 months ]

percent change in established biomarkers (troponin, BNP)

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: June 8, 2020)

multidisciplinary team interventions [ Time Frame: change from baseline to 12 months ]

nutrition, exercise, physiotherapy interventions

• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Multidisciplinary Team IntervenTion in CArdio-ONcology (TITAN Study)
• Official Title: Multidisciplinary Team IntervenTion in CArdio-ONcology

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 Provided
• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Supportive care intervention

Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care

• Condition: Breast Cancer

Intervention

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

Study Arms

• Experimental: multidisciplinary team intervention
  Intervention arm receives regular assessments and treatments from cardiology team, clinical nutrition, pharmacist, exercise physiologist and physiotherapist
  Intervention: Behavioral: Multidisciplinary team intervention
• No Intervention: Observational arm
  Participants randomized to observational arm will receive usual care.

• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: October 1, 2019): 80
• Original Estimated Enrollment (submitted: June 13, 2012): 282
• Estimated Study Completion Date: June 30, 2025
• Actual Primary Completion Date: May 30, 2018 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01621659
• Other Study ID Numbers: TITAN 102
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Alberta
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Alberta
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Alberta
• Verification Date: July 2023