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Идёт набор NCT06274034

MUSE-S Headband System for Improving Anxiety and Insomnia Among Breast Cancer Survivors

Ранняя фаза I С лечением Breast Carcinoma

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: Electronic Health Record Review, Medical Device Usage and Evaluation, Meditation Therapy, Survey Administration.
Кому может быть актуально
Состояния в реестре: Breast Carcinoma. Базовые параметры: 18 лет — 80 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 →

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Официальное название

Pilot Study of a Wearable EEG Headband as a Meditation Device for Breast Cancer Survivors

Обзор

This early phase I trial evaluates the feasibility and impact of a meditation headband system (MUSE-S) for breast cancer survivors. Anxiety and insomnia are among the most common distresses in breast cancer survivors during and after chemotherapy, in part due to the side effects of chemotherapy, fear of cancer coming back, progression of the cancer, and uncertainty of the future. These distresses impair patients' well-being and quality of life (QOL) in general, and their cancer treatment adherence and effectiveness in particular. Meditation has been demonstrated to be an effective management tool of stress and anxiety and is given the highest level of evidence (grade A) in the systematic review-based guidelines by the Society of Integrative Medicine. The portable, interactive, electroencephalographic (EEG) Muse headband guided meditation has been shown to improve fatigue, QOL, and stress in newly diagnosed breast cancer patients. The MUSE-S Headband System may decrease anxiety and insomnia among breast cancer survivors.

Подробное описание

PRIMARY OBJECTIVES:

I. To evaluate the frequency of use of meditation (a stress management technique) among breast cancer survivors.

II. To evaluate the feasibility of a wearable EEG headband, MUSE S, together with smartphone or tablet application (app) to guide breast cancer survivors' interactive meditation and sleep support.

III. To measure the impact of interactive meditation and sleep support through MUSE S among breast cancer survivors during or after chemotherapy on improving symptoms of anxiety and insomnia.

OUTLINE:

Patients wear the MUSE S headband to bed every night for 8 weeks and meditate using the MUSE phone app during day hours for at least 5 minutes over 8 weeks.

Вмешательства

  • Другое Electronic Health Record Review
    Ancillary studies
  • Другое Medical Device Usage and Evaluation
    Wear MUSE S headband
  • Процедура Meditation Therapy
    Participate in meditation
  • Другое Survey Administration
    Ancillary studies

Первичные конечные точки

  • Frequency of use of meditation [Срок оценки: Baseline; 6 weeks]
  • Feasibility of a wearable electroencephalographic (EEG) headband (Muse™ S Headband) [Срок оценки: 6 weeks]
  • Impact of interactive meditation and sleep support through the Muse-S™ system [Срок оценки: Baseline; 6 weeks]

Критерии участия

Критерии включения

  • Age between 18-80
  • Breast cancer first diagnosed with stage 1-4 breast cancer in the past 10 years
  • Patients report experiencing anxiety and insomnia both rated > 3 on a 0-10 scale (with 0 indicating none) at the time of enrollment
  • Patients on anti-anxiety/anti-depressant medication must be on stable dose for 1 month prior to study enrollment and must stay on that same dose throughout the trial
  • Has smart phone or tablet
  • Patient willing to use Google-based anonymous email account to sign up for MUSE
  • Be willing to provide informed consent and complete all aspects of the study
  • Have no contraindicating comorbid health condition which would interfere with the proper use of the Muse-S (trademark) system, as determined by the clinical investigators

Критерии исключения

  • Pregnant or breastfeeding individuals
  • Individuals who have used a regular mindfulness practice or received integrative medicine therapy, including acupuncture/acupressure, mindfulness or stress-reduction programs, massage, and/or energy therapies within the past 60 days
  • Currently taking medication for insomnia
  • An exclusionary unstable medical or mental health condition as determined by the patient's oncologist

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • Mayo Clinic in Rochester — Rochester

Идентификаторы

NCT: NCT06274034 · 23-006870

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗