Breast CancerPhase 2TITANNCT01621659
Multidisciplinary Team IntervenTion in CArdio-ONcology (TITAN Study)
A Phase 2 study testing Multidisciplinary team intervention in people with Breast Cancer, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Multidisciplinary team intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- May 2014to 3 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed malignancy (breast or lymphoma);
- scheduled to receive anthracycline and/or trastuzumab-based chemotherapy;
- age ≥ 18 years;
- willing to attend follow-up visits.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Breast Cancer
- Being tested
- Multidisciplinary team intervention
- Keywords
- multidisciplinary team, exercise, nutrition, cardiology, physiotherapy, imaging
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary team interventionBehavioural
Also called cardiology assessment and intervention, nutritional assessment and intervention, exercise assessment and training, pharmacist assessment and counseling
Intervention arm receives regular assessments and treatments from cardiology team, clinical nutrition, pharmacist, exercise physiologist and physiotherapist
| Study group | Role | What they receive |
|---|---|---|
| multidisciplinary team intervention | Experimental | Intervention arm receives regular assessments and treatments from cardiology team, clinical nutrition, pharmacist, exercise physiologist and physiotherapist Receives: Behavioral: Multidisciplinary team intervention |
| Observational arm | No intervention | Participants randomized to observational arm will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac MRI
left ventricular ejection fraction (LVEF)
Measured: change from baseline to 12 months
Secondary outcomes (1)
serum biomarkers
percent change in established biomarkers (troponin, BNP)
Measured: change from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startMay 2014
- Primary completion30 May 2018
- Study completion3 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Supportive care intervention
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621659
- Sponsor's protocol ID
- TITAN 102
- Acronym
- TITAN
- Status last verified
- May 2026
- First submitted
- 4 Jun 2012
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Kirkham AA, Mackey JR, Thompson RB, Haykowsky MJ, Oudit GY, McNeely M, Coulden R, Stickland MK, Baracos VE, Dyck JRB, Haennel R, Pituskin E, Paterson DI. TITAN Trial: A Randomized Controlled Trial of a Cardiac Rehabilitation Care Model in Breast Cancer. JACC Adv. 2023 Jul 27;2(6):100424. doi: 10.1016/j.jacadv.2023.100424. eCollection 2023 Aug.
PubMed 38939428Maayah ZH, Ferdaoussi M, Boukouris AE, Takahara S, Das SK, Khairy M, Mackey JR, Pituskin E, Sutendra G, Paterson DI, Dyck JRB. Endothelin Receptor Blocker Reverses Breast Cancer-Induced Cardiac Remodeling. JACC CardioOncol. 2023 May 2;5(5):686-700. doi: 10.1016/j.jaccao.2023.02.004. eCollection 2023 Oct.
PubMed 37969640Pituskin 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.
PubMed 27629548
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Team IntervenTion in CArdio-ONcology
- ClinicalTrials.gov ID
- NCT01621659
- Acronym / sponsor ID
- TITAN / TITAN 102
- Conditions
- Breast Cancer
- Keywords
- multidisciplinary team, exercise, nutrition, cardiology, physiotherapy, imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 3 Dec 2026 (estimated)
- First posted
- 18 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Supportive care intervention
| Arm | Type | Receives |
|---|---|---|
| multidisciplinary team intervention | Experimental | Behavioral: Multidisciplinary team interventionIntervention arm receives regular assessments and treatments from cardiology team, clinical nutrition, pharmacist, exercise physiologist and physiotherapist |
| Observational arm | No intervention | –Participants randomized to observational arm will receive usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- histologically confirmed malignancy (breast or lymphoma);
- scheduled to receive anthracycline and/or trastuzumab-based chemotherapy;
- age ≥ 18 years;
- willing to attend follow-up visits.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary team interventionAlso: cardiology assessment and intervention, nutritional assessment and intervention, exercise assessment and training, pharmacist assessment and counselingIntervention arm receives regular assessments and treatments from cardiology team, clinical nutrition, pharmacist, exercise physiologist and physiotherapist | Behavioural | multidisciplinary team intervention |
Primary outcome
cardiac MRI
Time frame: change from baseline to 12 months
left ventricular ejection fraction (LVEF)
1 secondary outcome
serum biomarkers
Time frame: change from baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Derived from this study: PubMed 38939428Kirkham AA, Mackey JR, Thompson RB, Haykowsky MJ, Oudit GY, McNeely M, Coulden R, Stickland MK, Baracos VE, Dyck JRB, Haennel R, Pituskin E, Paterson DI. TITAN Trial: A Randomized Controlled Trial of a Cardiac Rehabilitation Care Model in Breast Cancer. JACC Adv. 2023 Jul 27;2(6):100424. doi: 10.1016/j.jacadv.2023.100424. eCollection 2023 Aug.
- Derived from this study: PubMed 37969640Maayah ZH, Ferdaoussi M, Boukouris AE, Takahara S, Das SK, Khairy M, Mackey JR, Pituskin E, Sutendra G, Paterson DI, Dyck JRB. Endothelin Receptor Blocker Reverses Breast Cancer-Induced Cardiac Remodeling. JACC CardioOncol. 2023 May 2;5(5):686-700. doi: 10.1016/j.jaccao.2023.02.004. eCollection 2023 Oct.
- Derived from this study: PubMed 27629548Pituskin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Multidisciplinary team intervention in people with Breast Cancer, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiac MRI (time frame: change from baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01621659, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.