Evaluation Of Cardiovascular Health Outcomes Among Survivors 2 (ECHOS2)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 26 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Currently participating in a long-term follow-up program that provides risk-based screening
研究组 & 干预措施
Standard of Care (SOC)
Participants receive a personalized survivorship care plan and educational materials about cardiomyopathy risk and screening recommendations.
干预措施: Survivorship Care Plan + Educational Materials (delivered via CIAS platform) (Behavioral)
Healthy Hearts eHealth Intervention
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.
干预措施: Healthy Hearts eHealth Program (Behavioral)
结局指标
主要结局
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.
时间窗: 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.
时间窗: 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.
次要结局
未报告次要终点