Chronic Pain Due to Cancer, Pain Catastrophizing
Conditions
Keywords
Empowered Relief, Chronic Pain, Cancer survivor, Survey Study, Monthly follow-ups, Zoom class
Brief summary
This randomized controlled study to examine the efficacy of ER class in cancer survivors with chronic pain. Eligible participants will be randomly assigned to a ER class or a waitlist control condition. We will recruit 250 participants with a goal of having 200 completers (20% attrition). Participants in the control condition will be invited to attend ER class after the 3-month observation period.
Detailed description
The Empowered Relief (ER) study is a Zoom-based, 1-session, 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 use and supportive daily text messages. Participants will fill out a series of follow-up surveys at the 1, 2, and 3-month post-class mark. These surveys will be directly compared to surveys given to participants that do not complete the course. Class admittance will be randomized, however, participants not in the treatment group will have the option to take the course after the 3-month observatory period. 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. Because of its brief, didactic nature and delivery via Zoom, ER can accommodate large class sizes and may address access disparities among underserved cancer survivors. ER is currently 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. Yet, Empowered Relief has not been tested in cancer survivors.
Interventions
BEHAVIORALEmpowered Relief Course (Zoom)
This is a one-time 2 hour long 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 use and supportive daily text messages.
Sponsors
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
History of cancer diagnosis, completion of active cancer treatment, cancer free at the time of enrollment, experience of body pain most or every day, pain duration at least 3 months, and 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), and no access to a computer, a smartphone or a tablet.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall treatment satisfaction | Immediately after intervention | 0-10 scale, higher scores indicate greater satisfaction, mean should be 8 or higher |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | 1 month after intervention | 0-10 scale, higher scores indicate higher pain |
| Pain Interference | 1 month after intervention | T-scores, higher scores indicate higher pain interference |
Countries
United States
Contacts
CONTACTSophia You, PhD, ABPP
CONTACTJordan Keast, BS
PRINCIPAL_INVESTIGATORSophia You, PhD, ABPP
University of Oklahoma
Outcome results
None listed