Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT07245420
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation Of Cardiovascular Health Outcomes Among Survivors 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2025-11-03', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants who Received Cardiomyopathy Screening at 12 months between Participants Randomized to the Healthy Hearts eHealth Intervention group as compared to the standard of care.', 'timeFrame': '12 months', 'description': 'This outcome will be measured through self-reported questionnaire at 12 months along with confirmation through medical record review.'}, {'measure': 'Difference in Precursors to Cardiomyopathy Screening at 12 months between Participants Randomized to the Healthy Hearts eHealth Intervention group as Compared to the Standard of Care.', 'timeFrame': '12 months', 'description': 'This outcome will use questions included in the baseline and 12 month questionnaire to calculate the differences in precursors to cardiomyopathy screening (perceived barriers, knowledge, motivation, beliefs, self-efficacy) at 12 months between participants randomized to Healthy Hearts eHealth Intervention vs participants assigned to standard care.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Childhood Cancer Survivors', 'Cardiomyopathy Screening', 'eHealth Intervention'], 'conditions': ['Health Behavior']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.stjude.org', 'label': "St. Jude Children's Research Hospital"}, {'url': 'http://www.stjude.org/protocols', 'label': 'Clinical Trials Open at St. Jude'}]}, 'descriptionModule': {'briefSummary': 'Childhood cancer survivors who received certain treatments are at a higher risk of developing heart problems in the future. This study is looking at ways to educate childhood cancer survivors about that risk and encourage them to receive a recommended heart screening test.', 'detailedDescription': 'Primary Objective:\n\n* To determine the efficacy of the Healthy Hearts eHealth intervention compared to standard of care for improving screening echocardiogram adherence in childhood cancer survivors.\n\nSecondary Objective\n\n* To determine the efficacy of the Healthy Hearts eHealth intervention compared to standard of care for improving mediators of screening echocardiogram adherence in childhood cancer survivors.\n\nAfter consenting, participants will complete a survey that will take about 15-20 minutes to complete. After this survey, they will be randomly assigned to participate in the Healthy Hearts eHealth Intervention or to receive standard educational materials about hearth health screening.\n\nAll participants will receive the Standard of Care (SOC) materials delivered via the Computerized Intervention Authoring System (CIAS) platform (i.e., a personalized survivorship care plan and educational materials regarding cardiomyopathy risk and need for screening). In addition to the SOC materials received by controls, the Healthy Hearts eHealth intervention arm will receive CIAS platform delivered Motivational Interview (MI), including scripted interaction with an avatar, video vignettes, and patient testimonials'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '26 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Childhood Cancer Survivor Study (CCSS) Participants\n* Age ≥26 years\n* Treated with cumulative doxorubicin equivalent anthracycline doses ≥100 mg/m2 with any/no radiation, or ≥15 Gy chest radiation with any/no anthracyclines\n* No history of cardiomyopathy\n* Has not had an echocardiogram in the previous 5 years\n* Has a history of successful completion of CCSS surveys\n* English-Speaking\n* Has not been enrolled in ECHOS-1 (pilot)\n\nExclusion Criteria:\n\n• Currently participating in a long-term follow-up program that provides risk-based screening'}, 'identificationModule': {'nctId': 'NCT07245420', 'briefTitle': 'Evaluation Of Cardiovascular Health Outcomes Among Survivors 2', 'organization': {'class': 'OTHER', 'fullName': "St. Jude Children's Research Hospital"}, 'officialTitle': 'Evaluation Of Cardiovascular Health Outcomes Among Survivors 2 (ECHOS2)', 'orgStudyIdInfo': {'id': 'ECHOS2'}, 'secondaryIdInfos': [{'id': '1R01CA297448', 'link': 'https://reporter.nih.gov/quickSearch/1R01CA297448', 'type': 'NIH'}, {'id': 'NCI-2025-07891', 'type': 'OTHER', 'domain': 'NCI Clinical Trial Registration Program'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care (SOC)', 'description': 'Participants receive a personalized survivorship care plan and educational materials about cardiomyopathy risk and screening recommendations.', 'interventionNames': ['Behavioral: Survivorship Care Plan + Educational Materials (delivered via CIAS platform)']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Hearts eHealth Intervention', 'description': 'Participants receive the same SOC materials plus a tailored eHealth intervention using CIAS. This includes avatar-led motivational interviewing, survivor video vignettes, and interactive modules addressing screening barriers.', 'interventionNames': ['Behavioral: Healthy Hearts eHealth Program']}], 'interventions': [{'name': 'Survivorship Care Plan + Educational Materials (delivered via CIAS platform)', 'type': 'BEHAVIORAL', 'description': 'Participants receive a personalized survivorship care plan and educational materials about cardiomyopathy risk and screening recommendations. Materials are delivered via the CIAS platform and include infographics, treatment summaries, and general information about screening.', 'armGroupLabels': ['Standard of Care (SOC)']}, {'name': 'Healthy Hearts eHealth Program', 'type': 'BEHAVIORAL', 'description': 'Participants receive the same SOC materials plus a tailored, interactive eHealth intervention delivered via the CIAS platform. This includes avatar-led motivational interviewing (MI), survivor video vignettes, interactive modules addressing perceived barriers, self-efficacy, and goal setting. The intervention is designed to mimic MI counseling in a scalable format.', 'armGroupLabels': ['Healthy Hearts eHealth Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthew Ehrhardt, MD, MS, MPI', 'role': 'CONTACT', 'email': 'referralinfo@stjude.org', 'phone': '866-278-5833'}, {'name': 'Matthew Ehrhardt, MD, MS, MPI', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St. Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'centralContacts': [{'name': 'Matthew Ehrhardt, MD, MS, MPI', 'role': 'CONTACT', 'email': 'referralinfo@stjude.org', 'phone': '866-278-5833'}], 'overallOfficials': [{'name': 'Matthew Ehrhardt, MD, MS, MPI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Jude Children's Research Hospital"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data will be made available at the time of article publication.', 'ipdSharing': 'YES', 'description': 'Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.', 'accessCriteria': 'Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Jude Children's Research Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}