Feasibility and Acceptability of Empowered Relief for American Indians With Pain During and After Cancer Treatment

NCT07742449 | Not Yet Recruiting DMC

• 1 other identifier: 20065Ph1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Pain; Pain Management; Chronic Pain; American Indian or Alaska Native

Keywords

Cancer; Cancer Survivor; Pain; Chronic Pain; Native American; American Indian

Outcome Measures

Primary Outcomes (7)

• 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

  From participant accrual to the completion of their 3-mon follow up survey (approx. 4 months)

• 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)

• Pain Intensity

  Pilot data on clinical outcomes to estimate effect sizes and inform power calculations for a fully powered randomized trial. These measures will be collected using a series of verified survey questionnaires.

  Data collected at the 1-, 2-, and 3-month follow up survey following the ER class

• Pain Interference

  Pilot data on clinical outcomes to estimate effect sizes and inform power calculations for a fully powered randomized trial. These measures will be collected using a series of verified survey questionnaires.

  Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.

• Emotional Distress

  Pilot data on clinical outcomes to estimate effect sizes and inform power calculations for a fully powered randomized trial. These measures will be collected using a series of verified survey questionnaires.

  Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.

• Sleep Disturbance

  Pilot data on clinical outcomes to estimate effect sizes and inform power calculations for a fully powered randomized trial. These measures will be collected using a series of verified survey questionnaires.

  Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.

• Perceived Quality of Life

  Pilot data on clinical outcomes to estimate effect sizes and inform power calculations for a fully powered randomized trial. These measures will be collected using a series of verified survey questionnaires.

  Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.

Study Arms (1)

Empowered Relief

EXPERIMENTAL

Participants in this arm will complete a 2-hour Empowered Relief pain management course and get access to all the course materials. They will complete a series of follow-up surveys assessing the feasibility of the class for their pain intervention.

Behavioral: Empowered Relief

Interventions

Empowered Relief BEHAVIORAL

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.

Empowered Relief

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Stephenson Cancer Center - Tulsa Location

Tulsa, Oklahoma, 74104, United States

Location

MeSH Terms

Conditions

Neoplasms; Pain; Agnosia; Chronic Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Sophia You

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordan Keast

CONTACT

405-615-1474; jordan-keast@ou.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: August 3, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)