Меню
Идёт набор NCT06747910

Assessment of Remote Approaches for Identification of Autonomic Dysfunction Among Survivors of Leukemia and Lymphoma

Без фазы С лечением Childhood Cancer

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: Exercise Intervention - Ewing Battery Assessment, Questionnaire Administration, Medical Device Usage and Evaluation.
Кому может быть актуально
Состояния в реестре: Childhood Cancer. Базовые параметры: от 18 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

This study seeks to determine if diagnosing cardiac autonomic dysfunction (AD) can be done remotely with the same accuracy as in-person testing. If so, the identification of AD could happen sooner, facilitating remote studies of the condition and potentially reducing the risk of illness. Childhood cancer survivors, particularly survivors of acute lymphoblastic leukemia (ALL) and Hodgkins's lymphoma (HL), appear to be at increased risk for AD. Primary Objectives: * To determine the sensitivity and specificity of heart rate variability (HRV), measured remotely with biosensor technology (Actigraph LEAP), compared to in-person assessment using the Ewing battery as the reference standard to identify cardiac autonomic dysfunction (AD) among survivors of leukemia and lymphoma. * To determine the sensitivity and specificity of the Composite Autonomic Symptom Scale 31 (COMPASS31) compared to the Ewing battery to identify AD among leukemia and lymphoma survivors.

Подробное описание

Each participant will complete an in-person standardized clinical assessment for AD, called the Ewing battery. during the participants' Human Performance Lab during their SJLIFE functional exam. It is estimated it will take 60-90-minutes to complete the Ewing battery. The tests include monitoring heart rate variations during deep breathing and lying down to standing, as well as monitoring blood pressure variations when standing and maintaining hand grip. Participants will be asked to not consume aspirin, ibuprofen or acetaminophen 24-hours before the assessment. Additionally, participants will be asked to avoid alcohol or caffeine within 6-hours, and smoking 3-hours, before testing.

After the in-person assessment, each participant will be given a wrist biosensor to remotely monitor heart rate variability for 7 days after they return home. Participants will also complete an AD symptom questionnaire, COMPASS31. The AD symptom questionnaire will be completed either before or after the in-person assessment. This questionnaire will take about 20-30 minutes to complete.

Вмешательства

  • Другое Exercise Intervention - Ewing Battery Assessment
    Undergo in-person Ewing battery assessment
  • Другое Questionnaire Administration
    Receive COMPASS31 questionnaire
  • Устройство Medical Device Usage and Evaluation
    Wear biosensensor heart monitor that remotely collects heart rate variability.

Первичные конечные точки

  • Heart rate variability (msec) [Срок оценки: Up to 7 days after the on-campus study visit]
  • Abbreviated Composite Autonomic Symptom Score (0-100) [Срок оценки: During the on-campus study visit (Day 1)]
  • Ewing Score (0-5) [Срок оценки: During the on-campus study visit (Day 1)]

Критерии участия

Критерии включения

  • Participants enrolled in St. Jude Lifetime Cohort (SJLIFE) >18 years of age.
  • Primary diagnosis of acute lymphoblastic leukemia (ALL), Hodgkin's Lymphoma (HL), or Non-Hodgkin's Lymphoma (Non-HL).
  • Not currently taking beta-blocker medication.

Критерии исключения

  • Individuals who cannot speak, read, and/or understand English.
  • Individuals who are unable to follow directions/instructions in order to complete the Ewing battery.
  • Individuals with acute heart failure (new or worsening signs and symptoms of heart failure, including a combination of the following: dyspnea, orthopnea, lower limb swelling, elevated jugular venous pressure, and pulmonary congestion).
  • Women who are currently pregnant.

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
Скрининг

Центры проведения

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

Идентификаторы

NCT: NCT06747910 · READ · NCI-2025-00603

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗