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Идёт набор NCT02596490

Couple-Based Meditation for Metastatic Lung Cancer Patients and Their Partners

Без фазы С лечением Lung Cancer

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: Questionnaires, Meditation and Discussion Sessions, Cancer-Related Discussion Program.
Кому может быть актуально
Состояния в реестре: Lung Cancer. 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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Обзор

Objectives: Our specific aims are to: Aim 1: Examine the feasibility of a couple-based meditation program in 50 patients with metastatic lung cancer and their partners. Aim 2: Establish the initial efficacy of a couple-based meditation program in patients and their partners regarding physical, psychological, and spiritual quality of life outcomes.

Вмешательства

  • Поведенческое Questionnaires
    Phase 1: At end of second meditation and discussion session, couples complete complete a written review about the program in general and a questionnaire about their general health and well-being. Phase 2: Couples complete 12 questionnaires before first meditation and discussion session. Questionnaires ask about participant's health, mood, level of fatigue, sleeping habits, their relationship, and quality of life. Same questionnaires completed 1 week after mediation sessions. Phase 3: Participa
  • Поведенческое Meditation and Discussion Sessions
    Phase 1: Participant and partner attend 2 meditation sessions with a mediation trained instructor. Each session will last about 60-90 minutes. Phase 2 and 3: Participant and partner attend meditation class with a trained meditation instructor each week for 4 weeks. Each session will last about 60 minutes total. Meditation and discussion sessions videotaped.
  • Поведенческое Cancer-Related Discussion Program
    Phase 3: Participant and partner attend 1 discussion session each week for 4 weeks with a trained interventionist. During the discussion sessions, participants discuss issues for couples coping with cancer. Each session will last about 60 minutes.

Первичные конечные точки

  • Efficacy of Couple-Based Meditation for Participants with Lung Cancer and Their Partners [Срок оценки: 4 months]
  • Feasibility of Couple-Based Meditation for Participants with Lung Cancer and Their Partners [Срок оценки: 4 months]
  • Feasibility of Couple-Based Meditation for Participants with Lung Cancer and Their Partners [Срок оценки: 4 months]
  • Feasibility of Couple-Based Meditation for Participants with Lung Cancer and Their Partners [Срок оценки: 4 months]

Критерии участия

Критерии включения

  • ALL PHASES, PATIENTS ONLY: Diagnosed with stage IV Non-Small Cell Lung Cancer (NSCLC)
  • ALL PHASES, PATIENTS ONLY: Currently receiving treatment (e.g. radiotherapy, chemotherapy) at MD Anderson Cancer Center
  • ALL PHASES, PATIENTS ONLY: Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
  • ALL PHASES, PATIENTS ONLY: Have a romantic partner with whom they have resided for a minimum of 6 months
  • ALL PHASES, PATIENTS AND PARTNERS: Must be at least 18 years old
  • ALL PHASES, PATIENTS AND PARTNERS: Able to read and speak English
  • ALL PHASES, PATIENTS AND PARTNERS: Able to provide consent.

Критерии исключения

  • ALL PHASES, PATIENTS AND PARTNERS: Not oriented to time, place, or person as deemed by the clinical team
  • ALL PHASES, PATIENTS AND PARTNERS: Regular (self-defined) participation in psychotherapy or a formal cancer support group
  • ALL PHASES, PATIENTS AND PARTNERS: Prior enrollment in a couple-based mind-body intervention research study (protocols 2011-1179, 2013-0496, 2014-0036) conducted by the principal investigator including phase 1 or phase 2 of the current study.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 2 центра
  • Memorial Hermann — Houston
  • University of Texas MD Anderson Cancer Center — Houston

Публикации

  • Milbury K, Tsao AS, Liao Z, Owns A, Engle R, Gonzalez EA, Bruera E, Cohen L. A research protocol for a pilot randomized controlled trial designed to examine the feasibility of a couple-based mind-body intervention for patients with metastatic lung cancer and their partners. Pilot Feasibility Stud. 2018 Jan 24;4:37. doi: 10.1186/s40814-018-0231-6. eCollection 2018. PMID 29416870

Идентификаторы

NCT: NCT02596490 · 2015-0275 · 1R21CA191711 · NCI-2015-02128

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗