Идёт набор NCT06590285

Diagnostic Refinement and Educational Approaches in Managing Bone Marrow Transplantation

Без фазы С лечением GVHD Bone Marrow Transplant Complications

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: App-based Educational Intervention.
Кому может быть актуально: Состояния в реестре: GVHD, Bone Marrow Transplant Complications. 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

Diagnostic Refinement and Educational Approaches in Managing Bone Marrow Transplantation (DREAM-BMT)

Обзор

This randomized, phase I/II, open-label study will investigate the efficacy and safety of an educational sleep intervention vs standard of care in adults undergoing alloHSCT. The randomization target in this pilot phase is 60 patients.

Подробное описание

To facilitate rapid randomization and baseline collection of patient samples in the patient's home environment, screening activities and assessment of inclusion and exclusion criteria will begin once the patient is identified as transplant eligible at the bone marrow transplant meeting. The patient will subsequently be contacted by a study investigator to explain the study, including its potential benefits and risks.

Patients meeting all inclusion and exclusion criteria will be randomized 1:1 to receive either educational intervention or standard of care therapy.

Вмешательства

Поведенческое App-based Educational Intervention
The program's educational content is designed to engage patients in the science of sleep and recovery. Segments like "The Sleep Adventure" demystify complex neurobiological processes in an accessible format, aligning with emerging trends in patient education that focus on engagement and knowledge empowerment. Concurrently, the program's physical activity component is meticulously crafted, offering safe, supportive exercises that correspond with the treatment stages of alloHSCT patients. This asp

Первичные конечные точки

Objective Sleep Measurement [Срок оценки: Continuous measurement throughout the study duration (from 2 weeks prior to alloHSCT to 100 days post-alloHSCT)]

Вторичные конечные точки (2)

Objective activity measurement [Срок оценки: Continuous measurement throughout the study duration (from 2 weeks prior to alloHSCT to 100 days post-alloHSCT).]
Subjective sleep quality [Срок оценки: Measurements will occur 12 days prior to alloHSCT, 10 days after alloHSCT and 60 days after alloHSCT]

Критерии участия

Критерии включения

Male or female patients aged 18 or older at the time of study informed consent.
Have plan to undergo alloHSCT from any donor source using bone marrow, peripheral blood stem cells, or cord blood. Recipients of non-myeloablative, myeloablative and reduced intensity conditioning are eligible.
Patients have access to digital device capable of downloading study app
Patients able to read study documents and able to complete informed consent within the study app