Feasibility and Acceptability of Empowered Relief for American Indians With Pain During and After Cancer Treatment (ejames3)
This project will evaluate the feasibility and acceptability of Empowered Relief (ER) among American Indian adults who are currently receiving or have completed active cancer treatments at Stephenson Cancer Center (SCC). ER is a single-session, Zoom-based, 2-hour, skills-based pain management class delivered by certified instructors. Participants learn three core pain relief skills, develop a personalized plan, and receive access to a free binaural audio app for daily practice. ER has demonstrated moderate efficacy in individuals with chronic non-cancer pain, reducing pain intensity, pain interference, pain-related distress (pain catastrophizing), sleep disturbance, and anxiety at 3 and 6 months post-treatment. Because of its brief, didactic nature and Zoom delivery, ER can accommodate large class sizes and may address accessibility disparities among underserved cancer populations. While ER is being studied across various non-cancer populations and has been adopted as standard of care in leading healthcare institutions in the U.S. and abroad, it has not been tested in American Indians with cancer.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Jordan Keast
- Номер телефона: 405-615-1474
- Электронная почта: jordan-keast@ou.edu
Места учебы
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Oklahoma
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Tulsa, Oklahoma, Соединенные Штаты, 74104
- Stephenson Cancer Center - Tulsa Location
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Контакт:
- Sophia You
- Номер телефона: 918-660-3925
- Электронная почта: dokyoung-you@ou.edu
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Identifies as American Indian
- Has history of a cancer diagnosis
- Is currently undergoing or has completed active cancer treatment
- Experiences body pain most or every day
- Pain duration at least 3 months
- English fluency
Exclusion Criteria:
- Significant psychological and cognitive impairment that limits one's ability to complete study tasks (completion of online survey, attending the Zoom-based ER class)
- Life-threatening acute illness (e.g., infection, heart attack, injury)
- No access to a computer, a smartphone, or a tablet
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 |
|---|---|
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Экспериментальный: Empowered Relief
Participants in this arm will complete a 2-hour Empowered Relief pain management course and get access to all the course materials. Participants will complete a series of follow-up surveys assessing the feasibility of the class for their pain intervention. |
ER is a single-session, Zoom-based, 2-hour, skills-based pain management class delivered by certified instructors. Participants learn three core pain relief skills, develop a personalized plan, and receive access to a free binaural audio app for daily practice. ER has demonstrated moderate efficacy in individuals with chronic non-cancer pain, reducing pain intensity, pain interference, pain-related distress (pain catastrophizing), sleep disturbance, and anxiety at 3 and 6 months post-treatment. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Feasibility of ER in American Indian populations
Временное ограничение: From participant accrual to the completion of their 3-mon follow up survey (approx. 4 months)
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Indexed by:
Measures will be factored together to make an assessment on total feasibility. |
From participant accrual to the completion of their 3-mon follow up survey (approx. 4 months)
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Identify areas for cultural tailoring and improvement of ER
Временное ограничение: Assessed as part of the optional (n=30) Qualitative Post-class interview. (approx. 30 minutes)
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We will use qualitative data from interviews to generate actionable recommendations to improve the cultural engagement, acceptability, and relevance of ER for American Indians with cancer. |
Assessed as part of the optional (n=30) Qualitative Post-class interview. (approx. 30 minutes)
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Pain Intensity
Временное ограничение: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class
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Pain intensity will be reported on a scale from 1-10, with 1 being "No Pain" and 10 being "Worst Pain Imaginable." |
Data collected at the 1-, 2-, and 3-month follow up survey following the ER class
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Pain Interference
Временное ограничение: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
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Pain interference will be gauged using a series of questions decerning the impact of the participants participants pain on daily activities. Participants will rate the interference on a scale from 1-5, with 1 being "Not at All" and 5 being "Very Much." |
Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
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Emotional Distress
Временное ограничение: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
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Emotional distress will be measured using a series of questionnaires asking participants about the frequency of certain emotional reactions. Participants will report frequency on a scale from 1-5, with 1 being "Never" and 5 being "Always." |
Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
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Sleep Disturbance
Временное ограничение: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
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Sleep Disturbance will be recorded using a series of questions rating the quality and frequency of sleep. Participants will report on quality and frequency on a scale from 1-5, with 1 being "Very Poor/Not at All" and 5 being "Very Good/Very Much." |
Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
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Perceived Quality of Life
Временное ограничение: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
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Perceived Quality of Life will be reported on a scale from 1-5, with 1 being "Poor" and 5 being "Excellent." |
Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Sophia You, University of Oklahoma
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
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
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 20065Ph1
Планирование данных отдельных участников (IPD)
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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.
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