Recruiting

Observational Study

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT07245420

Conditions

Health Behavior

Eligibility Criteria

Sex: All

Age: 26+

Healthy Volunteers: Not accepted

Interventions

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

Healthy Hearts eHealth Program

Study Details

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.

Conditions

Health Behavior

Study ID

NCT07245420

Start date

Sep, 2026

Status verified date

Jun, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 26+

Healthy Volunteers: Not 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

Study Design

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Standard of Care (SOC)

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

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.

Interventions

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.

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Matthew Ehrhardt, MD, MS, MPI

888-226-4343referralinfo@stjude.org

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Matthew Ehrhardt, MD, MS, MPI

888-226-4343referralinfo@stjude.org

Principal Investigator:

Matthew Ehrhardt, MD, MS, MPI

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Keywords

  • Childhood Cancer Survivors
  • Cardiomyopathy Screening
  • eHealth Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-06-26.