Health BehaviorNCT07245420
Evaluation Of Cardiovascular Health Outcomes Among Survivors 2
A study testing Survivorship Care Plan + Educational Materials (delivered via CIAS platform) and Healthy Hearts eHealth Program in people with Health Behavior, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 26 years and older
- Conditions the study is for
- Health Behavior
- What is being tested?
- Survivorship Care Plan + Educational Materials (delivered via CIAS platform) and Healthy Hearts eHealth Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Currently participating in a long-term follow-up program that provides risk-based screening
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Matthew Ehrhardt, MD, MS, MPI, 888-226-4343, referralinfo@stjude.org
Matthew Ehrhardt, MD, MS, MPI
About this study
Official title: Evaluation Of Cardiovascular Health Outcomes Among Survivors 2 (ECHOS2)
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.
Read the 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
- Conditions
- Health Behavior
- Being tested
- Survivorship Care Plan + Educational Materials (delivered via CIAS platform), Healthy Hearts eHealth Program
- Keywords
- Childhood Cancer Survivors, Cardiomyopathy Screening, eHealth Intervention
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survivorship Care Plan + Educational Materials (delivered via CIAS platform)Behavioural
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 ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC) | Active comparator | Participants receive a personalized survivorship care plan and educational materials about cardiomyopathy risk and screening recommendations. Receives: Behavioral: Survivorship Care Plan + Educational Materials (delivered via CIAS platform) |
| 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. Receives: Behavioral: Healthy Hearts eHealth Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study startSep 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Matthew Ehrhardt, MD, MS, MPI, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245420
- Sponsor's protocol ID
- ECHOS2
- Other IDs
- 1R01CA297448, NCI-2025-07891
- Status last verified
- Jun 2026
- First submitted
- 3 Nov 2025
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Cardiovascular Health Outcomes Among Survivors 2 (ECHOS2)
- ClinicalTrials.gov ID
- NCT07245420
- Acronym / sponsor ID
- ECHOS2
- Conditions
- Health Behavior
- Keywords
- Childhood Cancer Survivors, Cardiomyopathy Screening, eHealth Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) | Active comparator | Behavioral: 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. |
| Healthy Hearts eHealth Intervention | Experimental | Behavioral: Healthy Hearts eHealth ProgramParticipants 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. |
Who may qualify
- Ages
- 26 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Currently participating in a long-term follow-up program that provides risk-based screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Standard of Care (SOC) |
| Healthy Hearts eHealth ProgramParticipants 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. | Behavioural | Healthy Hearts eHealth Intervention |
Primary outcome
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
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.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew Ehrhardt, MD, MS, MPI principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survivorship Care Plan + Educational Materials (delivered via CIAS platform) and Healthy Hearts eHealth Program in people with Health Behavior, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Ehrhardt, MD, MS, MPI (888-226-4343, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.