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Multidisciplinary Team Care for Breast Cancer (TITAN Trial)
Phase 2
Waitlist Available
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
histologically confirmed malignancy (breast or lymphoma);
scheduled to receive anthracycline and/or trastuzumab-based chemotherapy;
Must not have
previous radiotherapy to thorax.
previous anthracycline or trastuzumab-based therapy;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will assess whether receiving extra assessments and early interventions from teams of health care professionals is helpful for people diagnosed with cancer.
Who is the study for?
This trial is for adults over 18 with breast cancer or lymphoma, scheduled for specific chemotherapy treatments, and able to attend follow-ups. It's not for those with heart issues, prior thorax radiotherapy, previous similar chemo treatments, physical disability impeding certain tests, psychiatric conditions affecting consent, or involvement in related studies.
What is being tested?
The TITAN Study is testing whether extra care from a team of various health professionals (like nurses and dietitians) can benefit people with cancer during and after treatment. Participants will be randomly assigned to receive either this multidisciplinary intervention or the usual care.
What are the potential side effects?
Since this study focuses on additional assessments rather than medication side effects are not the main concern; however, any interventions introduced by the multidisciplinary team may carry their own risks depending on individual patient circumstances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer (breast or lymphoma) has been confirmed through tissue examination.
Select...
I am scheduled for chemotherapy that includes anthracycline or trastuzumab.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had radiation therapy to my chest area before.
Select...
I have had treatments with anthracycline or trastuzumab.
Select...
I do not have heart failure, cardiomyopathy, or an LVEF below 50%.
Select...
I have a physical disability that prevents me from undergoing exercise tests or DEXA scans.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
cardiac MRI
Secondary study objectives
serum biomarkers
Other study objectives
multidisciplinary team interventions
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: multidisciplinary team interventionExperimental Treatment1 Intervention
Intervention arm receives regular assessments and treatments from cardiology team, clinical nutrition, pharmacist, exercise physiologist and physiotherapist
Group II: Observational armActive Control1 Intervention
Participants randomized to observational arm will receive usual care.
Find a Location
Who is running the clinical trial?
University of AlbertaLead Sponsor
942 Previous Clinical Trials
434,315 Total Patients Enrolled
14 Trials studying Breast Cancer
2,541 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had radiation therapy to my chest area before.My cancer (breast or lymphoma) has been confirmed through tissue examination.I have had treatments with anthracycline or trastuzumab.I am scheduled for chemotherapy that includes anthracycline or trastuzumab.I am 18 years old or older.I do not have heart failure, cardiomyopathy, or an LVEF below 50%.You have a mental illness or condition that affects your ability to understand and make decisions about the study.I have a physical disability that prevents me from undergoing exercise tests or DEXA scans.You cannot participate if you are already participating in another study focused on heart health or exercise.
Research Study Groups:
This trial has the following groups:- Group 1: Observational arm
- Group 2: multidisciplinary team intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.