American Indian or Alaska Native, Cancer, Chronic Pain, Pain, Pain Management
Conditions
Keywords
Cancer, Cancer Survivor, Pain, Chronic Pain, Native American, American Indian
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.
Interventions
BEHAVIORALEmpowered 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.
Sponsors
University of Oklahoma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Disturbance | Data collected at the 1-, 2-, and 3-month follow up survey following the ER class. | 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." |
| Perceived Quality of Life | Data collected at the 1-, 2-, and 3-month follow up survey following the ER class. | Perceived Quality of Life will be reported on a scale from 1-5, with 1 being "Poor" and 5 being "Excellent." |
| Feasibility of ER in American Indian populations | 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 Measures will be factored together to make an assessment on total feasibility. |
| Identify areas for cultural tailoring and improvement of ER | 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. |
| Pain Intensity | Data collected at the 1-, 2-, and 3-month follow up survey following the ER class | Pain intensity will be reported on a scale from 1-10, with 1 being "No Pain" and 10 being "Worst Pain Imaginable." |
| Pain Interference | Data collected at the 1-, 2-, and 3-month follow up survey following the ER class. | 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." |
| Emotional Distress | Data collected at the 1-, 2-, and 3-month follow up survey following the ER class. | 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." |
Countries
United States
Contacts
CONTACTJordan Keast
PRINCIPAL_INVESTIGATORSophia You
University of Oklahoma
Outcome results
None listed