350 Participants Needed

Survivorship Education for Heart Health

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: St. Jude Children's Research Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help childhood cancer survivors understand their risk of heart problems later in life. It tests two educational approaches: one provides standard care materials about heart risk and screenings, while the other adds an online program with interactive tools to motivate heart health (the Healthy Hearts eHealth Program). The trial seeks survivors who haven't had a recent heart test and were treated with specific cancer therapies that increase heart risk. Participants should have completed previous study surveys and be comfortable using English. The study aims to encourage timely heart check-ups, which could be critical for long-term health.

As an unphased trial, this study offers a unique opportunity to contribute to research that could improve heart health education for future cancer survivors.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these educational methods are safe for childhood cancer survivors?

Research has shown that the Healthy Hearts eHealth Program is safe for participants. It improves lifestyle habits and lowers the risk of heart disease by encouraging more exercise and healthier eating. No reports of serious side effects or problems have emerged from using this program.

The program employs an interactive approach, featuring avatar-led interviews and video stories from other survivors, to help users overcome obstacles to heart health screenings. Participants have responded positively to this method, with no major issues reported.

Overall, the Healthy Hearts eHealth Program provides a safe and supportive way to promote heart health awareness and action among childhood cancer survivors.12345

Why are researchers excited about this trial?

Researchers are excited about the Survivorship Education for Heart Health trial because it explores innovative ways to improve heart health education among survivors. Unlike traditional methods that might just hand out printed materials, the trial uses the CIAS platform to deliver interactive content, including avatar-led motivational interviews and video vignettes from survivors. This approach could make learning about heart health more engaging and personalized, potentially leading to better understanding and adherence to recommended screenings. The hope is that these digital tools will break down barriers to care and encourage proactive management of heart health in a way that traditional pamphlets can't.

What evidence suggests that this trial's treatments could be effective for heart health in childhood cancer survivors?

The Healthy Hearts eHealth Program, available to participants in this trial, has been shown in studies to lower the risk of heart disease. In one study, participants using this program experienced a 6.7% decrease in their 10-year risk of coronary heart disease (CHD). Another study found that the program encourages important heart health check-ups. It includes interactive features like motivational talks and videos, which help individuals manage their heart health more effectively. Overall, evidence suggests that this program can reduce heart disease risk by promoting lifestyle changes and regular check-ups.12367

Who Is on the Research Team?

ME

Matthew Ehrhardt, MD, MS, MPI

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

This trial is for childhood cancer survivors who are at risk of heart problems due to their past treatments. Participants should be interested in learning about their cardiovascular health and willing to undergo recommended heart screening tests.

Inclusion Criteria

Has not had an echocardiogram in the previous 5 years
Childhood Cancer Survivor Study (CCSS) Participants
I am 26 years old or older.
See 5 more

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Survey

Participants complete a baseline survey to assess initial conditions and eligibility

1 day
1 visit (virtual)

Intervention

Participants receive either the Healthy Hearts eHealth intervention or standard educational materials

12 months
Ongoing virtual engagement

Follow-up

Participants are monitored for adherence to cardiomyopathy screening and changes in screening precursors

12 months
Self-reported questionnaire and medical record review

What Are the Treatments Tested in This Trial?

Interventions

  • Healthy Hearts eHealth Program
  • Survivorship Care Plan + Educational Materials (delivered via CIAS platform)

Trial Overview

The study evaluates the effectiveness of a Survivorship Care Plan with Educational Materials, delivered through the CIAS platform, versus an eHealth program called Healthy Hearts designed to educate survivors on cardiovascular risks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Healthy Hearts eHealth InterventionExperimental Treatment1 Intervention
Group II: Standard of Care (SOC)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials
451
Recruited
5,326,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

Evaluation Of Cardiovascular Health Outcomes Among ...

Number of Participants who Received Cardiomyopathy Screening at 12 months between Participants Randomized to the Healthy Hearts eHealth ...

The Healthy Hearts Project: Development and evaluation ...

Development and evaluation of a website for cardiovascular risk assessment and visualisation and self-management through healthy lifestyle goal-setting.

Healthy Hearts – A community-based primary prevention ...

The mean 10-year risk of CHD at baseline was 13.14% (SD 9.18) and had fallen at follow-up to 12.34% (SD 8.71), a mean reduction of 6.7% of the ...

Healthy Hearts California - CDPH - CA.gov

Healthy Hearts California (HHC) aims to be a driving force behind reducing the risk and prevalence of heart disease and stroke in our state.

Healthy Hearts Family Program for Cardiovascular Disease

This trial aims to determine if the Healthy Hearts Family Program, a 6-month family-based initiative, can reduce heart disease risk in Hispanic families in ...

Healthy Hearts

Improving cardiovascular health starts with accurate blood pressure measurement, documentation of data, and use of protocols. To improve health outcomes and ...

Process evaluation findings from Strong Hearts, Healthy ...

SHHC-2.0 was a 24-week cardiovascular disease prevention program that was effective in improving physical activity and nutrition behaviors and clinical ...