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: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Multidisciplinary team intervention

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

Number of Arms

2

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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiac MRI	left ventricular ejection fraction (LVEF)	change from baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum biomarkers	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	nutrition, exercise, physiotherapy interventions	change from baseline to 12 months

Collaborators and Investigators

• Sponsor: University of Alberta

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.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): May 30, 2018
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: June 4, 2012
• First Submitted That Met QC Criteria: June 13, 2012
• First Posted (Estimated): June 18, 2012

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: imaging; exercise; nutrition; physiotherapy; cardiology; multidisciplinary team
• Other Study ID Numbers: TITAN 102