University of Oklahoma Schusterman Center - Tulsa
Tulsa, Oklahoma, 74135, United States
Location status: Recruiting
NCT Number: NCT07578376
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.
Interested in participating?
Request Info18 year–120 year
All sexes
Interventional
Not applicable
Tulsa, Oklahoma, 74135, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
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.
Time frame: Immediately after intervention
0-10 scale, higher scores indicate greater satisfaction, mean should be 8 or higher
Time frame: 1 month after intervention
0-10 scale, higher scores indicate higher pain
Time frame: 1 month after intervention
T-scores, higher scores indicate higher pain interference
Time frame: 3 months after intervention
0-10 Scale, higher scores indicate higher pain
Time frame: 3 months after intervention
T-scores, higher scores indicate higher pain interference
Contact information is provided by the study sponsor or research team.
Jordan Keast, BS
CONTACT
Sophia You, PhD, ABPP
CONTACT
University of Oklahoma
Other
Feasibility and Preliminary Efficacy of Empowered Relief® for Cancer Survivors With Chronic Pain
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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