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Идёт набор NCT06960993

Mosaic Trial for Stem Cell Transplant Recipients

Без фазы С лечением Hematologic Malignancy Stem Cell Transplant Bone Marrow Transplant Leukemia

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: Intervention website, Enhanced Usual Care (Control) Website.
Кому может быть актуально
Состояния в реестре: Hematologic Malignancy, Stem Cell Transplant, Bone Marrow Transplant, Leukemia. 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 →

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Официальное название

Mosaic: RCT of a Digital Health Intervention for English- and Spanish-speaking Stem Cell Transplant Recipients

Обзор

The goal of this clinical trial is to learn if using an intervention website (Mosaic) improves selected patient-reported outcomes in adult blood cancer patients undergoing allogeneic or autologous stem cell transplant, compared to using an educational website (control group). Patients will be recruited prior to their scheduled transplant, then randomized to use one of these two study websites throughout the study. They will complete five assessments during the study: one before transplant (baseline) and four after transplant (2, 4, 6, and 8 month follow-ups). The main questions this trial aims to answer are: 1. Compared to patients using the control group website, do patients using the intervention website report greater improvements in general psychological distress, cancer treatment-related distress, physical symptoms, and health-related quality of life? 2. Are these benefits at least partially explained by improvements in perceived preparedness, self-efficacy, and approach coping and/or reductions in avoidant coping and perceived stress? 3. Do some patients benefit more from using the intervention website than others? Specifically, we will examine whether patients' primary language (English/Spanish) and their initial psychological distress are related to the benefit they get from using the intervention website. We will also explore effects of sex, race, ethnicity, and transplant type.

Вмешательства

  • Поведенческое Intervention website
    Website that includes experiential information, stress and coping resources, educational content, and links to trusted websites with additional educational content and links to psychosocial resources for transplant recipients and caregivers.
  • Поведенческое Enhanced Usual Care (Control) Website
    Website that includes stress and coping resources, educational content, and links to trusted websites with additional educational content and links to psychosocial resources for transplant recipients and caregivers.

Первичные конечные точки

  • Improvement in general psychological distress [Срок оценки: Baseline to 2 months post-transplant]
Вторичные конечные точки (12)
  • Improvement in general psychological distress [Срок оценки: Baseline to 4 months post-transplant]
  • Improvement in general psychological distress [Срок оценки: Baseline to 6 months post-transplant]
  • Improvement in general psychological distress [Срок оценки: Baseline to 8 months post-transplant]
  • Improvement in cancer treatment-related distress [Срок оценки: Baseline to 2 months post-transplant]
  • Improvement in cancer treatment-related distress [Срок оценки: Baseline to 4 months post-transplant]
  • Improvement in cancer treatment-related distress [Срок оценки: Baseline to 6 months post-transplant]
  • Improvement in cancer treatment-related distress [Срок оценки: Baseline to 8 months post-transplant]
  • Improvement in symptoms [Срок оценки: Baseline to 2 months post-transplant]
  • Improvement in symptoms [Срок оценки: Baseline to 4 months post-transplant]
  • Improvement in symptoms [Срок оценки: Baseline to 6 months post-transplant]
  • Improvement in symptoms [Срок оценки: Baseline to 8 months post-transplant]
  • Improvement in health-related quality of life [Срок оценки: Baseline to 2 months post-transplant]

Критерии участия

Критерии включения

  • Diagnosed with a hematologic cancer according to medical records
  • Scheduled for or preparing for scheduling of an allogeneic or autologous stem cell transplant at one of our study sites
  • Aged 18 or older (no upper limit)
  • English or Spanish Proficient
  • Interested in using a website to learn about stem cell transplant
  • Ability to understand and willingness to sign an informed consent document and comply with all study procedures

Критерии исключения

  • Currently participating in a behavioral intervention targeting distress, health-related quality of life, or symptoms
  • Undergoing the first in a planned tandem stem cell transplant
  • Unable to provide meaningful consent (severe cognitive impairment or language difficulties)

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
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

США · 3 центра
  • Georgetown University School of Medicine — Washington D.C.
  • Northwestern University Feinberg School of Medicine — Chicago
  • Hackensack Meridian Health — Nutley

Идентификаторы

NCT: NCT06960993 · STU00221336 · R01CA292116

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗