- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT03528863
Web-based Mindfulness Meditation in Reducing Distress in Participants With Metastatic Gastrointestinal Cancer and Their Caregivers
Being Present 2.0: Web-Based Mindfulness Meditation for Gastrointestinal Cancer Patients and Caregivers
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
PRIMARY OBJECTIVES:
I. To determine the feasibility and acceptability of an 8-week web-based mindfulness meditation program with live webinars among patients with a metastatic gastrointestinal (GI) cancer receiving chemotherapy and their caregivers.
SECONDARY OBJECTIVES:
I. Estimate the efficacy of an 8-week web-based mindfulness meditation program with live webinars among patients with a metastatic GI cancer receiving chemotherapy and their caregivers.
OUTLINE:
Participants practice with web-based mindfulness meditation over 10-15 minute guided audio sessions for 5 days a week for 8 weeks. Participants also attend meditation webinars over 60 minutes once a week, for 8 weeks.
After completion of study, participants are followed up at 8 weeks.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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California
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San Francisco, California, Соединенные Штаты, 94115
- University of California, San Francisco
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- ELIGIBLE PATIENTS: Carry a diagnosis of a metastatic GI cancer
- ELIGIBLE PATIENTS: Anticipate receiving chemotherapy for at least 12 weeks total from the time of recruitment
- ELIGIBLE PATIENTS: Have an estimated life expectancy of at least 6 months, assessed by principal investigator or treating investigator
- ELIGIBLE PATIENTS: Have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-2
- ELIGIBLE PATIENTS: Be able to speak and read English
- ELIGIBLE PATIENTS: Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet (assessed by participant self-report)
- ELIGIBLE PATIENTS: Have daily access to a mobile phone capable of receiving text messages, as determined by a study investigator
- ELIGIBLE PATIENTS: Be able to provide informed consent
- ELIGIBLE CAREGIVERS: Be a spouse/partner, other family member, or a close friend of a patient who consented to participate in the Being Present 2.0 study
- ELIGIBLE CAREGIVERS: Be able to speak and read English
- ELIGIBLE CAREGIVERS: Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet (assessed by participant self-report)
- ELIGIBLE CAREGIVERS: Have access to a mobile phone capable of receiving text messages, as determined by a study investigator
- ELIGIBLE CAREGIVERS: Be able to provide informed consent
Exclusion Criteria:
- Have a current meditation practice (> 2 episodes or > 1 hour total, weekly)
- Be currently enrolled in a stress reduction program
- Have extensive hearing loss such that ability to participate in the study would be impaired
- Have participated in the original Being Present pilot study (BP1)
- Be caregivers of patients who decline Being Present 2.0 (BP2) study participation
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: Supportive Care (web-based mindfulness meditation)
Participants practice with web-based mindfulness meditation over 10-15 minute guided audio sessions for 5 days a week for 8 weeks.
Participants also attend meditation webinars over 60 minutes once a week, for 8 weeks.
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Дополнительные исследования
Receive web-based mindfulness meditation
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Feasibility as assessed by evaluating recruitment rate
Временное ограничение: At end of enrollment (Up to 1 year)
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Number of participants approached who consent to participate
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At end of enrollment (Up to 1 year)
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Feasibility as assessed by evaluating rate of refusal to participate
Временное ограничение: At end of enrollment (Up to 1 year)
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Number of participants refusing to consent.
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At end of enrollment (Up to 1 year)
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Feasibility as assessed by rate of attrition
Временное ограничение: At 8 weeks post end of enrollment (Up to 1 year)
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Number of participants dropping out after start of intervention for any reason.
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At 8 weeks post end of enrollment (Up to 1 year)
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Acceptability as assessed by adherence to practice instructions
Временное ограничение: At 8 weeks after study start (Up to 1 year)
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Number of times participant practices during study, documented via website data capture
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At 8 weeks after study start (Up to 1 year)
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Acceptability as assessed by adherence to practice instructions
Временное ограничение: At 8 weeks after study start (Up to 1 year)
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Number of times participant watches recorded webinars, documented via website data capture
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At 8 weeks after study start (Up to 1 year)
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Acceptability as assessed by adherence to practice instructions
Временное ограничение: At 8 weeks after study start (Up to 1 year)
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Number of times patient participates in live webinars, documented via roll-call.
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At 8 weeks after study start (Up to 1 year)
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Acceptability as assessed by adherence to practice instructions
Временное ограничение: At 8 weeks after study start (Up to 1 year)
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Average duration of meditation session (measured in minutes), documented via website data capture.
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At 8 weeks after study start (Up to 1 year)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Efficacy as assessed by National Comprehensive Cancer Network (NCCN) Distress Thermometer
Временное ограничение: At baseline, week 4 and week 8 after study start (Up to 1 year)
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0 to 10, with 10 being the worst level of distress
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At baseline, week 4 and week 8 after study start (Up to 1 year)
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Efficacy as assessed by National Institutes of Health Patient Reported Outcomes Measurement Information System (NIH PROMIS)
Временное ограничение: At baseline, week 4 and week 8 after study start (Up to 1 year)
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At baseline, week 4 and week 8 after study start (Up to 1 year)
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Efficacy as assessed by a Five Facet Mindfulness Questionnaire Short (FFMQ-SF)
Временное ограничение: At baseline, week 4 and week 8 after study start (Up to 1 year)
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At baseline, week 4 and week 8 after study start (Up to 1 year)
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Efficacy as assessed by a "Are You at Peace?" one-item spiritual probe
Временное ограничение: At baseline, week 4 and week 8 after study start (Up to 1 year)
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At baseline, week 4 and week 8 after study start (Up to 1 year)
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Соавторы и исследователи
Соавторы
Следователи
- Главный следователь: Chloe Atreya, MD, University of California, San Francisco
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 174534 (Integrated Research Application System)
- NCI-2018-00622 (Идентификатор реестра: CTRP (Clinical Trial Reporting Program))
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования Администрация анкеты
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Assistance Publique - Hôpitaux de ParisЗавершенныйБолезнь Паркинсона | Дистонические расстройства | Функциональное двигательное расстройствоФранция
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Far Eastern Memorial HospitalЗавершенный
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University Hospital, Basel, SwitzerlandSwiss National Science FoundationРекрутингРасстройства поведения | Расстройство аутистического спектраШвейцария