Evaluation Of Cardiovascular Health Outcomes Among Survivors 2

NCT ID: NCT07245420

Last Updated: 2025-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2030-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Health Behavior

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard of Care (SOC)

Participants receive a personalized survivorship care plan and educational materials about cardiomyopathy risk and screening recommendations.

Group Type ACTIVE_COMPARATOR

Survivorship Care Plan + Educational Materials (delivered via CIAS platform)

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Healthy Hearts eHealth Program

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

St. Jude Children's Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Matthew Ehrhardt, MD, MS, MPI

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Matthew Ehrhardt, MD, MS, MPI

Role: CONTACT

866-278-5833

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Matthew Ehrhardt, MD, MS, MPI

Role: primary

866-278-5833

Related Links

Access external resources that provide additional context or updates about the study.

http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

Clinical Trials Open at St. Jude

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R01CA297448

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2025-07891

Identifier Type: OTHER

Identifier Source: secondary_id

ECHOS2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.