Evaluation Of Cardiovascular Health Outcomes Among Survivors 2

St. Jude Children's Research Hospital

Status: Enrolling

Conditions: Health Behavior

Treatments: Behavioral: Healthy Hearts eHealth Program; Behavioral: Survivorship Care Plan + Educational Materials (delivered via CIAS platform)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07245420

ECHOS2

1R01CA297448 (U.S. NIH Grant/Contract)

NCI-2025-07891 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 350 estimated patients

Sex: All

Ages: 26+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

Standard of Care (SOC)

Active Comparator group

Description:

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

Treatment:

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

Healthy Hearts eHealth Intervention

Experimental group

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.

Treatment:

Behavioral: Healthy Hearts eHealth Program