Evaluation Of Cardiovascular Health Outcomes Among Survivors 2

June 2, 2026 updated by: St. Jude Children's Research Hospital

Evaluation Of Cardiovascular Health Outcomes Among Survivors 2 (ECHOS2)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary Objective:

  • To determine the efficacy of the Healthy Hearts eHealth intervention compared to standard of care for improving screening echocardiogram adherence in childhood cancer survivors.

Secondary Objective

  • 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.

After 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.

All 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

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Recruiting
        • St. Jude Children's Research Hospital
        • Principal Investigator:
          • Matthew Ehrhardt, MD, MS, MPI
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

• Currently participating in a long-term follow-up program that provides risk-based screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care (SOC)
Participants receive a personalized survivorship care plan and educational materials about cardiomyopathy risk and screening recommendations.
Behavioral: Survivorship Care Plan + Educational Materials (delivered via CIAS platform)
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.
Experimental: Healthy Hearts eHealth Intervention
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.
Behavioral: Healthy Hearts eHealth Program
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 12 months
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.
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Jude Children's Research Hospital

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Matthew Ehrhardt, MD, MS, MPI, St. Jude Children's Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

November 3, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECHOS2
  • 1R01CA297448 (U.S. NIH Grant/Contract)
  • NCI-2025-07891 (Other Identifier: NCI Clinical Trial Registration Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan 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.

IPD Sharing Time Frame

Data will be made available at the time of article publication.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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