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Идёт набор NCT06532773

Mindfulness Intervention for Sleep Disturbance and Symptom Management in Hematologic Cancer Patients During and After Inpatient Treatment

Без фазы С лечением Hematologic Malignancy

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: Nite2Day+.
Кому может быть актуально
Состояния в реестре: Hematologic Malignancy. 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
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Обзор

People with hematologic cancer often have sleep disturbance and symptoms of fatigue, stress, and pain. This study is being done to test a mindfulness intervention for sleep disturbance and symptom management in patients with hematologic cancer during and after inpatient treatment (Nite2Day+). Participants will complete a baseline survey online, using a mobile application, or paper/pencil. Once the baseline survey is complete, participants will be randomized (like a flip of a coin) to receive Nite2Day+ or Standard Care. Nite2Day+ will include activities during and after inpatient treatment. During inpatient treatment, participants will use a mobile app to access: 1) mindfulness meditations, 2) brief sleep education videos, and 3) brief videos teaching strategies to improve sleep quality in the hospital. After inpatient treatment, participants will complete 6, videoconference sessions (45-60 minutes) with a trained therapist to learn mindfulness and behavioral coping strategies to self-manage nighttime sleep disturbance and daytime symptoms of fatigue, stress, and pain. Three follow-up surveys will occur at hospital discharge, and approximately 8, and 12 weeks after hospital discharge. Participants randomized to Nite2Day+ will be given the option to complete an exit interview to provide feedback on the Nite2Day+ program. Participants randomized to Standard Care will only complete the four surveys. All participants will continue to receive their usual medical care. The total study duration is about 16 weeks.

Вмешательства

  • Поведенческое Nite2Day+
    Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.

Первичные конечные точки

  • Feasibility as measured by study accrual [Срок оценки: 24 months of study recruitment]
  • Feasibility as measured by study attrition [Срок оценки: Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)]
  • Feasibility as measured by adherence [Срок оценки: Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)]
  • Acceptability as measured by the Client Satisfaction Questionnaire (CSQ) [Срок оценки: Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)]
  • Engagement as measured by Nite2Day+ app and skills use [Срок оценки: Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)]
  • Change in insomnia symptoms [Срок оценки: Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)]
Вторичные конечные точки (7)
  • Change in fatigue [Срок оценки: Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)]
  • Change in depressive symptoms [Срок оценки: Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)]
  • Change in anxiety symptoms [Срок оценки: Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)]
  • Change in pain severity [Срок оценки: Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)]
  • Change in pain interference [Срок оценки: Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)]
  • Change in mindfulness [Срок оценки: Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)]
  • Change in self-efficacy for symptom management [Срок оценки: Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)]

Критерии участия

Критерии включения

  • Male and female patients, >18 years old
  • Initial or recurrent diagnosis of acute myeloid leukemia, acute lymphoblastic leukemia, Non-Hodgkin's lymphoma, multiple myeloma, or myelodysplastic syndrome
  • at least 7 days of hospitalization for treatment (e.g., chemotherapy, CAR-T immunotherapy)
  • 8 or greater on the Insomnia Severity Index with timeframe adjusted to be "past 7 days"
  • Ability to speak and read English, and intact hearing and vision

Критерии исключения

  • Reported or suspected cognitive impairment, confirmed via Folstein Mini-Mental Status Exam <25
  • Serious psychiatric (e.g., schizophrenia, suicidal intent) or medical condition (e.g., seizure disorder, narcolepsy) indicated by medical chart, oncologist, or other provider
  • Expected survival of <6 months

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
Лечение

Центры проведения

США · 1 центр
  • 2400 Pratt Street — Durham

Идентификаторы

NCT: NCT06532773 · Pro00115799 · K08CA283026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗