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NCT Number: NCT07742449

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

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.

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Key information

Conditions

Cancer Agnosia American Indian or Alaska Native Chronic Pain Neoplasms Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of ER in American Indian populations

    Time frame: 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

  2. Identify areas for cultural tailoring and improvement of ER

    Time frame: 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.

  3. Pain Intensity

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

    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.

  4. Pain Interference

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

    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.

  5. Emotional Distress

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

    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.

  6. Sleep Disturbance

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

    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.

  7. Perceived Quality of Life

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jordan Keast

CONTACT

[email protected]

405-615-1474

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Acronym: ejames3

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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