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Not yet recruiting NCT07742449

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

No phase Interventional Cancer Pain Pain Management Chronic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Empowered Relief.
Who it may be relevant to
Registry conditions: Cancer, Pain, Pain Management, Chronic Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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)]
  • 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)]
  • Pain Intensity [Time frame: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class]
  • Pain Interference [Time frame: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.]
  • Emotional Distress [Time frame: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.]
  • Sleep Disturbance [Time frame: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.]
  • Perceived Quality of Life [Time frame: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Stephenson Cancer Center - Tulsa Location — Tulsa

Identifiers

NCT: NCT07742449 · 20065Ph1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗