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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA297448 | U.S. NIH Grant/Contract | View source | |
| NCI-2025-07891 | Other Identifier | NCI Clinical Trial Registration Program |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
Primary Objective:
Secondary Objective
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care (SOC) | Active Comparator | Participants receive a personalized survivorship care plan and educational materials about cardiomyopathy risk and screening recommendations. |
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| Healthy Hearts eHealth Intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
• Currently participating in a long-term follow-up program that provides risk-based screening
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew Ehrhardt, MD, MS, MPI | Contact | 888-226-4343 | referralinfo@stjude.org |
| Name | Affiliation | Role |
|---|---|---|
| Matthew Ehrhardt, MD, MS, MPI | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Recruiting | Memphis | Tennessee | 38105 | United States |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
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Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
Data will be made available at the time of article publication.
Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.
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| ID | Term |
|---|---|
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| 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. |
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