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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Oklahoma

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: Empowered ReliefExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From participant accrual to the completion of their 3-mon follow up survey (approx. 4 months)
2

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.

Time frame
Assessed as part of the optional (n=30) Qualitative Post-class interview. (approx. 30 minutes)
3

Pain Intensity

Pain intensity will be reported on a scale from 1-10, with 1 being "No Pain" and 10 being "Worst Pain Imaginable."

Time frame
Data collected at the 1-, 2-, and 3-month follow up survey following the ER class
4

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."

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: