Evaluation Of Cardiovascular Health Outcomes Among Survivors 2

ConditionHealth Behavior

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age26+

SponsorSt. Jude Children's Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

350 Participants

are divided into 2 treatment groups

Group A: Standard of Care (SOC)Active comparator 1 intervention

Group B: Healthy Hearts eHealth InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

This outcome will be measured through self-reported questionnaire at 12 months along with confirmation through medical record review.

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.

This outcome will use questions included in the baseline and 12 month questionnaire to calculate the differences in precursors to cardiomyopathy screening (perceived barriers, knowledge, motivation, beliefs, self-efficacy) at 12 months between participants randomized to Healthy Hearts eHealth Intervention vs participants assigned to standard care.

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

St. Jude Children's Research Hospital

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

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