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Набор скоро начнётся NCT07177846

LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Protocol for Patients Living With Metastatic Lung Cancer

Без фазы С лечением 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: LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Program.
Кому может быть актуально
Состояния в реестре: Survivorship. 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

In this pilot randomized controlled trial, patients with metastatic non-small cell lung cancer and at least mild distress (N=80) will be randomized to receive LiveWell, an adapted Dialectical Behavioral Therapy (DBT) Skills Training protocol) or Usual Care. The investigators will evaluate feasibility, acceptability, and preliminary efficacy of LiveWell to reduce distress (primary outcome) and improve psychological well-being, symptom burden, and quality of life (secondary outcomes). The investigators will explore emotion regulation as a potential mechanism of change.

Подробное описание

Participants will be randomized 1:1 to receive LiveWell, an eight-session, telehealth-delivered DBT Skills Training intervention tailored for lung cancer metavivors, or Usual Care. Participants will complete self-report measures at baseline, 8-week follow-up, and 3 month follow-up. It is hypothesized that: 1) RCT methods will demonstrate evidence of feasibility (accrual N=80/20 months, \>80% adherence to assigned interventions and assessments, \<25% attrition) and acceptability (\>3/5 satisfaction study procedures, \>3 mean intervention satisfaction LiveWell); 2) LiveWell participants will demonstrate reductions in distress (primary outcome) and improvements in psychological well-being (illness acceptance, positive affect, tolerance of uncertainty, mindfulness, self-efficacy to manage emotions and symptoms), symptom burden (fatigue, dyspnea, pain), and quality of life (secondary outcomes) compared to Usual Care participants at 8-week follow-up. H3. (Exploratory). To explore the role of emotion regulation as a potential mechanism of change.

Вмешательства

  • Поведенческое LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Program
    LiveWell: Adapted DBT Skills Training for Patients with Metastatic Lung Cancer

Первичные конечные точки

  • PROMIS Anxiety Short Form (8a) [Срок оценки: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)]
  • PROMIS Depression Short Form (8a) [Срок оценки: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)]
Вторичные конечные точки (10)
  • Intolerance of Uncertainty Scale - Short Form (IUS-12) [Срок оценки: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)]
  • Peace, Equanimity, and Acceptance in the Cancer (PEACE) - Peaceful Acceptance of Illness Subscale [Срок оценки: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)]
  • PROMIS Positive Affect Short Form (15a) [Срок оценки: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)]
  • Difficulty in Regulating Emotions Scale (DERS-18) [Срок оценки: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)]
  • Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) [Срок оценки: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)]
  • PROMIS Self-Efficacy for Managing Symptoms Short Form (8a) [Срок оценки: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)]
  • PROMIS Self-Efficacy for Managing Emotions (8a) Short Form [Срок оценки: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)]
  • NCI Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (NCI-PRO-CTCAE) [Срок оценки: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)]
  • Functional Assessment of Cancer Therapy - Lung (FACT-L) [Срок оценки: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)]
  • DBT Ways of Coping Checklist (DBT-WCCL) - DBT Skills Subscale (DSS) [Срок оценки: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)]

Критерии участия

Критерии включения

  • Age ≥ 18
  • AJCC Stage IV non-small cell lung cancer
  • Receiving treatment with non-curative intent
  • English proficiency
  • Able to provide informed consent
  • National Comprehensive Cancer Network distress screening score ≥ 3/10

Критерии исключения

  • Cognitive impairment
  • Untreated serious mental illness
  • Expected survival < 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
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07177846 · Pro00144605 · R00CA286959

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗