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Идёт набор NCT07245420

Evaluation Of Cardiovascular Health Outcomes Among Survivors 2

Без фазы С лечением Health Behavior

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Survivorship Care Plan + Educational Materials (delivered via CIAS platform), Healthy Hearts eHealth Program.
Кому может быть актуально
Состояния в реестре: Health Behavior. Базовые параметры: от 26 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Evaluation Of Cardiovascular Health Outcomes Among Survivors 2 (ECHOS2)

Обзор

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.

Подробное описание

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

Вмешательства

  • Поведенческое 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.
  • Поведенческое Healthy 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.

Первичные конечные точки

  • 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. [Срок оценки: 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. [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • Currently participating in a long-term follow-up program that provides risk-based screening

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

США · 1 центр
  • St. Jude Children's Research Hospital — Memphis

Идентификаторы

NCT: NCT07245420 · ECHOS2 · 1R01CA297448 · NCI-2025-07891

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗