Empowered Relief® for Cancer Survivors With Chronic Pain

Официальное название

Feasibility and Preliminary Efficacy of Empowered Relief® for Cancer Survivors With Chronic Pain

Обзор

This randomized controlled study to examine the efficacy of ER class in cancer survivors with chronic pain. Eligible participants will be randomly assigned to a ER class or a waitlist control condition. We will recruit 250 participants with a goal of having 200 completers (20% attrition). Participants in the control condition will be invited to attend ER class after the 3-month observation period.

Подробное описание

The Empowered Relief (ER) study is a Zoom-based, 1-session, 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 use and supportive daily text messages. Participants will fill out a series of follow-up surveys at the 1, 2, and 3-month post-class mark. These surveys will be directly compared to surveys given to participants that do not complete the course. Class admittance will be randomized, however, participants not in the treatment group will have the option to take the course after the 3-month observatory period. 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. Because of its brief, didactic nature and delivery via Zoom, ER can accommodate large class sizes and may address access disparities among underserved cancer survivors. ER is currently 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. Yet, Empowered Relief has not been tested in cancer survivors.

Вмешательства

• Поведенческое Empowered Relief Course (Zoom)
  This is a one-time 2 hour long 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 use and supportive daily text messages.

Первичные конечные точки

• Overall treatment satisfaction [Срок оценки: Immediately after intervention]

Вторичные конечные точки (4)

• Pain Intensity [Срок оценки: 1 month after intervention]
• Pain Interference [Срок оценки: 1 month after intervention]
• Pain Intensity [Срок оценки: 3 months after intervention]
• Pain Interference [Срок оценки: 3 months after intervention]

Критерии участия

Критерии включения

History of cancer diagnosis, completion of active cancer treatment, cancer free at the time of enrollment, experience of body pain most or every day, pain duration at least 3 months, and English fluency.

Критерии исключения

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), and no access to a computer, a smartphone or a tablet.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Oklahoma Schusterman Center - Tulsa — Tulsa

Идентификаторы

NCT: NCT07578376 · 18957P

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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