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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain; Cancer; Chronic Pain; Pain Management; American Indian or Alaska Native
• Intervention / Treatment: Behavioral: Empowered Relief

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jordan Keast; Phone Number: 405-615-1474; Email: jordan-keast@ou.edu

Study Locations

• United States
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Stephenson Cancer Center - Tulsa Location
      • Contact: Sophia You; Phone Number: 918-660-3925; Email: dokyoung-you@ou.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: Empowered Relief; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Assessed as part of the optional (n=30) Qualitative Post-class interview. (approx. 30 minutes)
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.	From participant accrual to the completion of their 3-mon follow up survey (approx. 4 months)
Pain Intensity	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
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."	Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
Emotional Distress	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.
Sleep Disturbance	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.
Perceived Quality of Life	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.

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Sophia You, University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 20, 2026
• First Submitted That Met QC Criteria: July 28, 2026
• First Posted (Actual): August 3, 2026

Study Record Updates

• Last Update Posted (Actual): August 20, 2026
• Last Update Submitted That Met QC Criteria: August 18, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; Pain; Chronic Pain; Cancer Survivor; Native American; American Indian
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Neoplasms; Chronic Pain; Agnosia
• Other Study ID Numbers: 20065Ph1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No