Evaluation Of Cardiovascular Health Outcomes Among Survivors 2
3 other identifiers
interventional
350
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2025
CompletedFirst Posted
Study publicly available on registry
November 24, 2025
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2029
Study Completion
Last participant's last visit for all outcomes
December 1, 2030
April 23, 2026
April 1, 2026
3.5 years
November 3, 2025
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
This outcome will be measured through self-reported questionnaire at 12 months along with confirmation through medical record review.
12 months
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.
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.
12 months
Study Arms (2)
Standard of Care (SOC)
ACTIVE COMPARATORParticipants receive a personalized survivorship care plan and educational materials about cardiomyopathy risk and screening recommendations.
Healthy Hearts eHealth Intervention
EXPERIMENTALParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Childhood Cancer Survivor Study (CCSS) Participants
- Age ≥26 years
- Treated with cumulative doxorubicin equivalent anthracycline doses ≥100 mg/m2 with any/no radiation, or ≥15 Gy chest radiation with any/no anthracyclines
- No history of cardiomyopathy
- Has not had an echocardiogram in the previous 5 years
- Has a history of successful completion of CCSS surveys
- English-Speaking
- Has not been enrolled in ECHOS-1 (pilot)
You may not qualify if:
- Currently participating in a long-term follow-up program that provides risk-based screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Ehrhardt, MD, MS, MPI
St. Jude Children's Research Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2025
First Posted
November 24, 2025
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
December 1, 2029
Study Completion (Estimated)
December 1, 2030
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be made available at the time of article publication.
- Access Criteria
- 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.
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.