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Recruiting NCT07245420

Evaluation Of Cardiovascular Health Outcomes Among Survivors 2

No phase Interventional Health Behavior

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Survivorship Care Plan + Educational Materials (delivered via CIAS platform), Healthy Hearts eHealth Program.
Who it may be relevant to
Registry conditions: Health Behavior. Basic parameters: from 26 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation Of Cardiovascular Health Outcomes Among Survivors 2 (ECHOS2)

Overview

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.

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

Interventions

  • 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.
  • 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.

Primary outcome measures

  • 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]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • St. Jude Children's Research Hospital — Memphis

Identifiers

NCT: NCT07245420 · ECHOS2 · 1R01CA297448 · NCI-2025-07891

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗