Multidisciplinary Team IntervenTion in CArdio-ONcology (TITAN Study)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2012 by University of Alberta
Sponsor:
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT01621659
First received: June 4, 2012
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

People with breast cancer and lymphoma 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 Intervention Phase
Breast Cancer
Lymphoma
Behavioral: Multidisciplinary team intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Multidisciplinary Team IntervenTion in CArdio-ONcology

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • echocardiography [ Time Frame: change from baseline to 12 months ] [ Designated as safety issue: No ]
    percentage of longitudinal strain from baseline


Secondary Outcome Measures:
  • serum biomarkers [ Time Frame: change from baseline to 12 months ] [ Designated as safety issue: No ]
    percent change in established biomarkers (troponin, BNP)


Estimated Enrollment: 282
Study Start Date: September 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01621659

Contacts
Contact: Ian Paterson, MD 780-407-1857 ip3@ualberta.ca
Contact: Edith Pituskin, PhD(c) 780-432-8518 pituskin@ualberta.ca

Locations
Canada, Alberta
Cross Cancer Institute Not yet recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
University of Alberta
  More Information

No publications provided

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01621659     History of Changes
Other Study ID Numbers: TITAN 102
Study First Received: June 4, 2012
Last Updated: June 13, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
multidisciplinary team
exercise
nutrition
cardiology
physiotherapy
imaging

Additional relevant MeSH terms:
Breast Neoplasms
Lymphoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 29, 2014