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Идёт набор NCT04512144

Mindfulness in Endometrial and Cervical Cancer

Без фазы С лечением Gynecologic Cancer Endometrial Cancer Cervical Cancer Quality of Life

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: Headspace Smartphone Application.
Кому может быть актуально
Состояния в реестре: Gynecologic Cancer, Endometrial Cancer, Cervical Cancer, Quality of Life. Базовые параметры: 18 лет — 90 лет · Женщины.
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 →
Официальное название

Mindfulness Practice in Endometrial and Cervical Cancers With Smartphone Applications (MECCA)

Обзор

Patients with endometrial cancer who will be undergoing surgery or patients with cervical cancer who will be treated with chemoradiation will be randomized to utilize the Headspace smartphone application or not prior to their anticipated treatment.

Подробное описание

A diagnosis of cancer can be a major stress-inducing event. The prevalence of depression in patients diagnosed with cancer is estimated up to 16%. Practicing mindfulness is a cost-effective treatment which can also help manage treatment adverse effects and cancer-related symptoms.

Even short exposure and practice of mindfulness exercises have demonstrated improved subjective and objective measurements of stress and anxiety with breast biopsies. Patients with breast cancer also have improved quality of life with mindfulness training. Self-guided mindfulness with smartphone applications, specifically the app Headspace, has been associated with positive benefits and ease of use in the general population and among cancer patients.

A patient's inherent level of baseline mindfulness has been associated with lower pain scores following minimally invasive hysterectomy. This study did not specifically encourage practice of mindfulness exercises. Our own study of post-operative opiate usage in women following minimally invasive hysterectomy contains self-reported data of women using opiates to relax or help sleep. This suggests that mindfulness exercises may improve quality of life in these areas and thus reduce opiate usage. Patients undergoing minimally invasive hysterectomy for treatment of endometrial cancer were specifically chosen as a study cohort to build on our own data and that currently reported in the literature as well as the highest incidence of this cancer as a gynecologic malignancy. The second study cohort chosen was women with cervical cancer undergoing definitive treatment with chemo-sensitizing radiation given the significant endeavor required for complete treatment. Additionally, these women are often younger with the diagnosis of cervical cancer often being their first major medical diagnosis.

Вмешательства

  • Поведенческое Headspace Smartphone Application
    Headspace is a smartphone application used for mindfulness, meditation, and stress reduction. It has been utilized in other behavioral and quality of life studies.

Первичные конечные точки

  • Opiate Usage-Endometrial cancer [Срок оценки: Enrollment to 30 days post op for endometrial cancer.]
  • Opiate Usage-Cervical Cancer [Срок оценки: Enrollment to 6 weeks post treatment for cervical cancer.]
Вторичные конечные точки (5)
  • Five Facet Mindfulness Questionnaire [Срок оценки: Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.]
  • Functional Assessment of Cancer Therapy-General [Срок оценки: Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.]
  • Complication Rates [Срок оценки: Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.]
  • Patient satisfaction [Срок оценки: Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.]
  • Compliance [Срок оценки: Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.]

Критерии участия

Критерии включения

  • New diagnosis of either 1) endometrial cancer undergoing surgery or 2) cervical cancer undergoing chemo-sensitizing radiation
  • Access to a smartphone

Критерии исключения

  • Non-English speaking
  • No access to smartphone
  • Current use of Headspace application

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 · 1 центр
  • Saint Louis University — St Louis

Идентификаторы

NCT: NCT04512144 · 30780

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗