Multidisciplinary Team IntervenTion in CArdio-ONcology (TITAN Study)

Sponsor

University of Alberta (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01621659

Collaborator

(none)

Enrollment

Location

Arms

134

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Supportive care interventionSupportive care intervention

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Multidisciplinary Team IntervenTion in CArdio-ONcology

Study Start Date :

May 1, 2014

Actual Primary Completion Date :

May 30, 2018

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

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.

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

Primary Outcome Measures

cardiac MRI [change from baseline to 12 months]
left ventricular ejection fraction (LVEF)

Secondary Outcome Measures

serum biomarkers [change from baseline to 12 months]
percent change in established biomarkers (troponin, BNP)

Other Outcome Measures

multidisciplinary team interventions [change from baseline to 12 months]
nutrition, exercise, physiotherapy interventions

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.