Feasibility and Acceptability of Empowered Relief for American Indians With Pain During and After Cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Identify areas for cultural tailoring and improvement of ER
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Empowered Relief (Behavioral)
结局指标
主要结局
Identify areas for cultural tailoring and improvement of ER
时间窗: Assessed as part of the optional (n=30) Qualitative Post-class interview. (approx. 30 minutes)
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.
Pain Interference
时间窗: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
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."
Feasibility of ER in American Indian populations
时间窗: From participant accrual to the completion of their 3-mon follow up survey (approx. 4 months)
Indexed by: * ≥70% attendance rate amongst all eligible participants * An average treatment satisfaction rating of ≥ 8 on a 0-10 scale (with 0 being completely dissatisfied and 10 being completely satisfied) * Successful recruitment and completion of 70 participants within one year Measures will be factored together to make an assessment on total feasibility.
Pain Intensity
时间窗: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class
Pain intensity will be reported on a scale from 1-10, with 1 being "No Pain" and 10 being "Worst Pain Imaginable."
Emotional Distress
时间窗: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
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."
Sleep Disturbance
时间窗: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
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."
Perceived Quality of Life
时间窗: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
Perceived Quality of Life will be reported on a scale from 1-5, with 1 being "Poor" and 5 being "Excellent."
次要结局
未报告次要终点