Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-26 @ 2:40 AM
Study NCT ID:
NCT01621659
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-19
First Post:
2012-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multidisciplinary Team IntervenTion in CArdio-ONcology (TITAN Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D015596', 'term': 'Nutrition Assessment'}, {'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Supportive care intervention'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-18', 'studyFirstSubmitDate': '2012-06-04', 'studyFirstSubmitQcDate': '2012-06-13', 'lastUpdatePostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'multidisciplinary team interventions', 'timeFrame': 'change from baseline to 12 months', 'description': 'nutrition, exercise, physiotherapy interventions'}], 'primaryOutcomes': [{'measure': 'cardiac MRI', 'timeFrame': 'change from baseline to 12 months', 'description': 'left ventricular ejection fraction (LVEF)'}], 'secondaryOutcomes': [{'measure': 'serum biomarkers', 'timeFrame': 'change from baseline to 12 months', 'description': 'percent change in established biomarkers (troponin, BNP)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['multidisciplinary team', 'exercise', 'nutrition', 'cardiology', 'physiotherapy', 'imaging'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '38939428', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '37969640', 'type': 'DERIVED', 'citation': 'Maayah 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.'}, {'pmid': '27629548', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "People with breast cancer often experience many short and long-term side effects as a result of both the cancer and the necessary treatments.\n\nReceiving 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.\n\nIn 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.\n\nAfter initial assessments, participants will be randomized to multidisciplinary team intervention or usual care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically confirmed malignancy (breast or lymphoma);\n* scheduled to receive anthracycline and/or trastuzumab-based chemotherapy;\n* age ≥ 18 years;\n* willing to attend follow-up visits.\n\nExclusion Criteria:\n\n* physical disability preventing exercise testing or DEXA scan;\n* psychiatric disease or disorder precluding informed consent;\n* participation in other cardiotoxicity or exercise intervention study;\n* contraindication to anti-cancer therapy, including known heart failure, cardiomyopathy, or baseline LVEF \\< 50%;\n* previous anthracycline or trastuzumab-based therapy;\n* previous radiotherapy to thorax.'}, 'identificationModule': {'nctId': 'NCT01621659', 'acronym': 'TITAN', 'briefTitle': 'Multidisciplinary Team IntervenTion in CArdio-ONcology (TITAN Study)', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'Multidisciplinary Team IntervenTion in CArdio-ONcology', 'orgStudyIdInfo': {'id': 'TITAN 102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'multidisciplinary team intervention', 'description': 'Intervention arm receives regular assessments and treatments from cardiology team, clinical nutrition, pharmacist, exercise physiologist and physiotherapist', 'interventionNames': ['Behavioral: Multidisciplinary team intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Observational arm', 'description': 'Participants randomized to observational arm will receive usual care.'}], 'interventions': [{'name': 'Multidisciplinary team intervention', 'type': 'BEHAVIORAL', 'otherNames': ['cardiology assessment and intervention', 'nutritional assessment and intervention', 'exercise assessment and training', 'pharmacist assessment and counseling', 'physiotherapy assessment and training'], 'description': 'Intervention arm receives regular assessments and treatments from cardiology team, clinical nutrition, pharmacist, exercise physiologist and physiotherapist', 'armGroupLabels': ['multidisciplinary team intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Cross Cancer Institute', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}