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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Jordan Keast
- 电话号码：405-615-1474
- 邮箱：jordan-keast@ou.edu
学习地点
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Oklahoma
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Tulsa、Oklahoma、美国、74104
- Stephenson Cancer Center - Tulsa Location
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接触：
- Sophia You
- 电话号码：918-660-3925
- 邮箱：dokyoung-you@ou.edu
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Feasibility of ER in American Indian populations
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
调查人员
- 首席研究员：Sophia You、University of Oklahoma
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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