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Набор по приглашению NCT06736548

Sleep Treatment Education Program for Cancer Survivors: STEP-Together

Без фазы С лечением Insomnia Insomnia Chronic Survivorship

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: The Sleep Treatment Education Program Together (STEP-Together), Coaching Session.
Кому может быть актуально
Состояния в реестре: Insomnia, Insomnia Chronic, Survivorship. Базовые параметры: 18 лет — 89 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

Sleep Treatment Education Program Together (STEP-Together): An Online Group Educational Intervention for Insomnia in Cancer Survivors

Обзор

This single-arm research study of off-treatment cancer survivors with self-reported symptoms of insomnia will test the Sleep Treatment Education Program Together (STEP-Together) intervention which is delivered as a synchronous group session by videoconference.

Подробное описание

This single-arm research study of off-treatment cancer survivors with self-reported symptoms of insomnia will test the Sleep Treatment Education Program Together (STEP-Together) intervention which is delivered as a virtual group session.

The research study procedures including screening for eligibility and questionnaires.

Participation in this research study is expected to last about 16 weeks.

It is expected about 90 people will participate in this research study.

Вмешательства

  • Поведенческое The Sleep Treatment Education Program Together (STEP-Together)
    STEP-Together is delivered in a single videoconference group session delivered live by a presenter. During the session, the participants are able to see and hear the presenter, view the presentation slides, and ask questions. The presentation includes educational information on the problem of insomnia after cancer and specific suggestions for improving sleep. Suggestions are presented in four sections addressing lifestyle issues, sleep environment, sleep timing, and managing expectations and cha
  • Поведенческое Coaching Session
    Coaching sessions are brief (\<1hour) sessions intended to support participants in implementing their personal sleep self-management plan. In the session, participants are asked to review their progress with their plan, report on areas of sucess and difficulty with adoption, and to problem solve with the study team as needed to support their sucessful implementation their plan.

Первичные конечные точки

  • Change in Insomnia Severity Index (ISI) Score from Baseline to 8 weeks Post-Intervention [Срок оценки: Baseline to 8 weeks post-intervention]
Вторичные конечные точки (3)
  • Change in Total Mood Disturbance (TMD) Scale from the Profile of Mood States - Short Form (POMS-SF) Score from Baseline to 8 weeks Post-Intervention [Срок оценки: Baseline to 8 weeks post-intervention]
  • Change in Perceived Cognitive impairment Scale from Baseline to 8 weeks Post-Intervention [Срок оценки: Baseline to 8 weeks post-intervention]
  • Change in Impact of Cognitive Function on Quality of Life Scale from Baseline to 8 weeks Post-Intervention [Срок оценки: Baseline to 8 weeks post-intervention]

Критерии участия

Критерии включения

  • Age 18-89
  • History of a cancer diagnosis (except non-melanoma skin cancer) ≥ 6 months prior
  • No active cancer therapy (excluding chemoprevention) in the past four months, and no further therapy planned.
  • Significant insomnia as evidenced by an Insomnia Severity Index score ≥ 8
  • Regular access to the internet
  • Able to read and write in English

Критерии исключения

  • Usual bedtime does not fall between 5:00 pm and 5:00 am.
  • Employment in a position where falling asleep at work could impact public safety (such as air traffic-controller, operating heavy machinery).
  • Ever diagnosed with Bipolar Disorder or with Seizure Disorder, currently taking medications to prevent a seizure, or have experienced a seizure in the prior 12 months.
  • Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all study procedures independently.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Dana Farber Cancer Institute — Boston

Идентификаторы

NCT: NCT06736548 · 24-505

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗