About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Empowered Relief
BehavioralER 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.
Treatment groups
Trial outcomes
Primary outcomes
Feasibility of ER in American Indian populations
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.
Identify areas for cultural tailoring and improvement of ER
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 Intensity
Pain intensity will be reported on a scale from 1-10, with 1 being "No Pain" and 10 being "Worst Pain Imaginable."
Pain Interference
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."
Sponsors and contacts
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