Health Behavior
Conditions
Keywords
Childhood Cancer Survivors, Cardiomyopathy Screening, eHealth Intervention
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.
Detailed 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
Interventions
BEHAVIORALSurvivorship 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.
BEHAVIORALHealthy 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.
Sponsors
St. Jude Children's Research Hospital
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
26 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 12 months | This outcome will be measured through self-reported questionnaire at 12 months along with confirmation through medical record review. |
| 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. | 12 months | 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. |
Countries
United States
Contacts
CONTACTMatthew Ehrhardt, MD, MS, MPI
PRINCIPAL_INVESTIGATORMatthew Ehrhardt, MD, MS, MPI
St. Jude Children's Research Hospital
Outcome results
None listed